NCT01122030 is a Phase 2 clinical trial of Naldemedine in Opioid Induced Bowel Dysfunction, sponsored by Shionogi.

Who is sponsoring NCT01122030?

NCT01122030 is sponsored by Shionogi.

What drugs are being tested in NCT01122030?

Interventions in NCT01122030: Naldemedine, Placebo.

What condition does NCT01122030 study?

NCT01122030 studies Opioid Induced Bowel Dysfunction.

Is NCT01122030 still recruiting?

NCT01122030 is currently completed. Last updated 30 May 2017.

Are results published for NCT01122030?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2017-05-30 · How we verify

NCT01122030

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Study to Evaluate the Safety and Efficacy of Naldemedine (S-297995) for the Treatment of Opioid-Induced Bowel Dysfunction in Subjects With Chronic Pain

Completed Phase 2 Results posted Last updated 30 May 2017

What this trial tests

Phase 2 trial testing Naldemedine in Opioid Induced Bowel Dysfunction in 72 participants. Completed in 22 March 2011.

Timeline

19 May 2010

Primary endpoint
23 February 2011

22 March 2011

Quick facts

Lead sponsor	Shionogi
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	single group
Masking	triple
Primary purpose	treatment
Enrollment	72
Start date	19 May 2010
Primary completion	23 February 2011
Estimated completion	22 March 2011
Sites	1 location across United States

Drugs / interventions tested

Naldemedine (NALDEMEDINE) — full drug profile →
Placebo

Conditions studied

Opioid Induced Bowel Dysfunction — all drugs for Opioid Induced Bowel Dysfunction →

Sponsor

Shionogi — full company profile →

Who can join

Adults 18 to 65, any sex, with Opioid Induced Bowel Dysfunction. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Adverse Events Primary · From the first dose of study drug on Day 15 up to Day 24.

Severity of adverse events (AEs) was graded according to the following definitions: * Mild: The subject experiences awareness of symptoms but these are easily tolerated or managed without specific treatment * Moderate: The subject experiences discomfort enough to cause interference with usual activity, and/or the condition requires specific treatment * Severe: The subject is incapacitated with inability to work or do usual activity, and/or the event requires significant treatment measures. The relationship of the event to the study drug was determined by the investigator. A serious adverse

Any adverse event

Group	Value	95% CI
Pooled Placebo	9
Naldemedine 0.01 mg	6
Naldemedine 0.03 mg	6
Naldemedine 0.1 mg	5
Naldemedine 0.3 mg	9
Naldemedine 1 mg	9
Naldemedine 3 mg	9

Mild adverse events

Group	Value	95% CI
Pooled Placebo	9
Naldemedine 0.01 mg	6
Naldemedine 0.03 mg	6
Naldemedine 0.1 mg	4
Naldemedine 0.3 mg	6
Naldemedine 1 mg	5
Naldemedine 3 mg	1

Moderate adverse events

Group	Value	95% CI
Pooled Placebo	0
Naldemedine 0.01 mg	0
Naldemedine 0.03 mg	0
Naldemedine 0.1 mg	1
Naldemedine 0.3 mg	3
Naldemedine 1 mg	3
Naldemedine 3 mg	2

Severe adverse events

Group	Value	95% CI
Pooled Placebo	0
Naldemedine 0.01 mg	0
Naldemedine 0.03 mg	0
Naldemedine 0.1 mg	0
Naldemedine 0.3 mg	0
Naldemedine 1 mg	1
Naldemedine 3 mg	6

Treatment-related adverse events

Group	Value	95% CI
Pooled Placebo	6
Naldemedine 0.01 mg	5
Naldemedine 0.03 mg	3
Naldemedine 0.1 mg	1
Naldemedine 0.3 mg	9
Naldemedine 1 mg	8
Naldemedine 3 mg	9

Deaths

Group	Value	95% CI
Pooled Placebo	0
Naldemedine 0.01 mg	0
Naldemedine 0.03 mg	0
Naldemedine 0.1 mg	0
Naldemedine 0.3 mg	0
Naldemedine 1 mg	0
Naldemedine 3 mg	0

Serious adverse events

Group	Value	95% CI
Pooled Placebo	0
Naldemedine 0.01 mg	0
Naldemedine 0.03 mg	0
Naldemedine 0.1 mg	0
Naldemedine 0.3 mg	0
Naldemedine 1 mg	0
Naldemedine 3 mg	0

Adverse events leading to discontinuation

Group	Value	95% CI
Pooled Placebo	0
Naldemedine 0.01 mg	0
Naldemedine 0.03 mg	0
Naldemedine 0.1 mg	0
Naldemedine 0.3 mg	0
Naldemedine 1 mg	0
Naldemedine 3 mg	0

Change From Baseline to 24 Hours Post-dose in Number of Spontaneous Bowel Movements (SBMs) Per Day Secondary · Baseline (Day 1 to Day 15) and Day 15 to 16 (0 to 24 hours post-dose)

Participants completed a bowel function assessment daily diary to record information about bowel movements and constipation. A spontaneous bowel movement was defined as a bowel movement where no laxative or enema was used in the 24 hours preceding the bowel movement. Baseline was defined as the average number of SBMs per day during the 2 weeks prior to receiving study drug (Day 1 to Day 15).

Baseline

Group	Value	95% CI
Pooled Placebo	0.15	± 0.13
Naldemedine 0.01 mg	0.20	± 0.14
Naldemedine 0.03 mg	0.24	± 0.09
Naldemedine 0.1 mg	0.13	± 0.13
Naldemedine 0.3 mg	0.17	± 0.12
Naldemedine 1 mg	0.13	± 0.09
Naldemedine 3 mg	0.23	± 0.11

24 hours post-dose

Group	Value	95% CI
Pooled Placebo	0.44	± 0.51
Naldemedine 0.01 mg	0.11	± 0.33
Naldemedine 0.03 mg	0.67	± 0.71
Naldemedine 0.1 mg	0.56	± 0.73
Naldemedine 0.3 mg	2.00	± 1.32
Naldemedine 1 mg	3.89	± 3.06
Naldemedine 3 mg	5.00	± 2.12

Change from Baseline to 24 hours post-dose

Group	Value	95% CI
Pooled Placebo	0.29	± 0.48
Naldemedine 0.01 mg	-0.09	± 0.41
Naldemedine 0.03 mg	0.42	± 0.72
Naldemedine 0.1 mg	0.43	± 0.68
Naldemedine 0.3 mg	1.83	± 1.34
Naldemedine 1 mg	3.76	± 3.06
Naldemedine 3 mg	4.77	± 2.15

Change From Baseline to 48 Hours Post-dose in the Number of SBMs Per Day Secondary · Baseline (Day 1 to Day 15) and Day 15 to Day 17 (0 to 48 hours post-dose)

Baseline

Group	Value	95% CI
Pooled Placebo	0.15	± 0.13
Naldemedine 0.01 mg	0.20	± 0.14
Naldemedine 0.03 mg	0.24	± 0.09
Naldemedine 0.1 mg	0.13	± 0.13
Naldemedine 0.3 mg	0.17	± 0.12
Naldemedine 1 mg	0.13	± 0.09
Naldemedine 3 mg	0.23	± 0.11

48 hours post-dose

Group	Value	95% CI
Pooled Placebo	0.36	± 0.33
Naldemedine 0.01 mg	0.44	± 0.39
Naldemedine 0.03 mg	0.67	± 0.61
Naldemedine 0.1 mg	0.39	± 0.49
Naldemedine 0.3 mg	1.06	± 0.68
Naldemedine 1 mg	2.28	± 1.80
Naldemedine 3 mg	2.67	± 1.03

Change from Baseline to 48 hours post-dose

Group	Value	95% CI
Pooled Placebo	0.21	± 0.32
Naldemedine 0.01 mg	0.24	± 0.39
Naldemedine 0.03 mg	0.42	± 0.65
Naldemedine 0.1 mg	0.26	± 0.45
Naldemedine 0.3 mg	0.88	± 0.68
Naldemedine 1 mg	2.15	± 1.81
Naldemedine 3 mg	2.44	± 1.05

Change From Baseline to 24 Hours Post-dose in Number of Bowel Movements (BM) Per Day Secondary · Baseline and 24 hours post-dose

Participants completed a bowel function assessment daily diary to record information about bowel movements and constipation. Baseline was defined as the average number of BMs per day during the 2 weeks prior to receiving study drug (Day 1 to Day 15).

Baseline

Group	Value	95% CI
Pooled Placebo	0.35	± 0.18
Naldemedine 0.01 mg	0.34	± 0.10
Naldemedine 0.03 mg	0.41	± 0.22
Naldemedine 0.1 mg	0.35	± 0.17
Naldemedine 0.3 mg	0.33	± 0.12
Naldemedine 1 mg	0.29	± 0.09
Naldemedine 3 mg	0.38	± 0.19

24 hours post-dose

Group	Value	95% CI
Pooled Placebo	0.50	± 0.62
Naldemedine 0.01 mg	0.11	± 0.33
Naldemedine 0.03 mg	0.67	± 0.71
Naldemedine 0.1 mg	0.56	± 0.73
Naldemedine 0.3 mg	2.00	± 1.32
Naldemedine 1 mg	3.89	± 3.06
Naldemedine 3 mg	5.00	± 2.12

Change from Baseline to 24 hours post-dose

Group	Value	95% CI
Pooled Placebo	0.15	± 0.65
Naldemedine 0.01 mg	-0.23	± 0.36
Naldemedine 0.03 mg	0.25	± 0.75
Naldemedine 0.1 mg	0.21	± 0.76
Naldemedine 0.3 mg	1.67	± 1.35
Naldemedine 1 mg	3.60	± 3.10
Naldemedine 3 mg	4.62	± 2.06

Change From Baseline to 48 Hours Post-dose in Number of Bowel Movements Per Day Secondary · Baseline and 48 hours post-dose

Baseline

Group	Value	95% CI
Pooled Placebo	0.35	± 0.18
Naldemedine 0.01 mg	0.34	± 0.10
Naldemedine 0.03 mg	0.41	± 0.22
Naldemedine 0.1 mg	0.35	± 0.17
Naldemedine 0.3 mg	0.33	± 0.12
Naldemedine 1 mg	0.29	± 0.09
Naldemedine 3 mg	0.38	± 0.19

48 hours post-dose

Group	Value	95% CI
Pooled Placebo	0.50	± 0.51
Naldemedine 0.01 mg	0.61	± 0.49
Naldemedine 0.03 mg	0.72	± 0.71
Naldemedine 0.1 mg	0.56	± 0.46
Naldemedine 0.3 mg	1.06	± 0.68
Naldemedine 1 mg	2.28	± 1.80
Naldemedine 3 mg	2.67	± 1.03

Change from baseline to 48 hours post-dose

Group	Value	95% CI
Pooled Placebo	0.15	± 0.53
Naldemedine 0.01 mg	0.27	± 0.51
Naldemedine 0.03 mg	0.31	± 0.67
Naldemedine 0.1 mg	0.21	± 0.52
Naldemedine 0.3 mg	0.72	± 0.70
Naldemedine 1 mg	1.99	± 1.82
Naldemedine 3 mg	2.29	± 0.98

Change From Baseline to 24 Hours Post-dose in Number of Complete Spontaneous Bowel Movements (CSBMs) Per Day Secondary · Baseline and 24 hours post-dose

Participants completed a bowel function assessment daily diary to record information about bowel movements and constipation. A complete spontaneous bowel movement was defined as a bowel movement where no laxative or enema was used and the bowel movement resulted in a sensation of complete evacuation (based on the question of "having a feeling of complete emptying after the bowel movement"). Baseline was defined as the average number of CSBMs per day during the 2 weeks prior to receiving study drug (Day 1 to Day 15).

Baseline

Group	Value	95% CI
Pooled Placebo	0.03	± 0.06
Naldemedine 0.01 mg	0.07	± 0.09
Naldemedine 0.03 mg	0.07	± 0.08
Naldemedine 0.1 mg	0.06	± 0.10
Naldemedine 0.3 mg	0.01	± 0.03
Naldemedine 1 mg	0.03	± 0.04
Naldemedine 3 mg	0.10	± 0.07

24 hours post-dose

Group	Value	95% CI
Pooled Placebo	0.06	± 0.24
Naldemedine 0.01 mg	0.00	± 0.00
Naldemedine 0.03 mg	0.11	± 0.33
Naldemedine 0.1 mg	0.22	± 0.44
Naldemedine 0.3 mg	0.11	± 0.33
Naldemedine 1 mg	2.44	± 2.55
Naldemedine 3 mg	3.00	± 3.20

Change from Baseline to 24 hours post-dose

Group	Value	95% CI
Pooled Placebo	0.02	± 0.25
Naldemedine 0.01 mg	-0.07	± 0.09
Naldemedine 0.03 mg	0.04	± 0.29
Naldemedine 0.1 mg	0.16	± 0.44
Naldemedine 0.3 mg	0.10	± 0.34
Naldemedine 1 mg	2.42	± 2.55
Naldemedine 3 mg	2.90	± 3.24

Change From Baseline to 48 Hours Post-dose in Number of Complete Spontaneous Bowel Movements (CSBMs) Per Day Secondary · Baseline and 48 hours post-dose

Baseline

Group	Value	95% CI
Pooled Placebo	0.03	± 0.06
Naldemedine 0.01 mg	0.07	± 0.09
Naldemedine 0.03 mg	0.07	± 0.08
Naldemedine 0.1 mg	0.06	± 0.10
Naldemedine 0.3 mg	0.01	± 0.03
Naldemedine 1 mg	0.03	± 0.04
Naldemedine 3 mg	0.10	± 0.07

48 hours post-dose

Group	Value	95% CI
Pooled Placebo	0.08	± 0.19
Naldemedine 0.01 mg	0.17	± 0.25
Naldemedine 0.03 mg	0.17	± 0.25
Naldemedine 0.1 mg	0.17	± 0.35
Naldemedine 0.3 mg	0.06	± 0.17
Naldemedine 1 mg	1.39	± 1.34
Naldemedine 3 mg	1.61	± 1.52

Change from baseline to 48 hours post-dose

Group	Value	95% CI
Pooled Placebo	0.05	± 0.16
Naldemedine 0.01 mg	0.10	± 0.18
Naldemedine 0.03 mg	0.10	± 0.25
Naldemedine 0.1 mg	0.10	± 0.34
Naldemedine 0.3 mg	0.04	± 0.17
Naldemedine 1 mg	1.36	± 1.34
Naldemedine 3 mg	1.51	± 1.56

Time to First Spontaneous Bowel Movement Secondary · From first dose on Day 15 through Day 17

The time to first SBM during the Study Drug Administration Period was summarized using Kaplan-Meier estimates. Each participant's first SBM was counted as an event and the time to first SBM after dosing was calculated from the date and time of first dosing until the date and time of first SBM. Participants who dropped out or were lost to follow-up before the first SBM were censored.

Group	Value	95% CI
Pooled Placebo	27.2	12.4 – NA
Naldemedine 0.01 mg	37.0	25.8 – NA
Naldemedine 0.03 mg	13.9	8.2 – NA
Naldemedine 0.1 mg	NA	3.3 – NA
Naldemedine 0.3 mg	4.7	2.8 – 6.2
Naldemedine 1 mg	1.4	1.0 – 2.3
Naldemedine 3 mg	0.7	0.6 – 0.8

Time to First Bowel Movement Secondary · From first dose on Day 15 through Day 17

The time to first BM during the Study Drug Administration Period was summarized using Kaplan-Meier estimates. Each participant's first BM was counted as an event and the time to first BM after dosing was calculated from the date and time of first dosing until the date and time of first BM. Participants who dropped out or were lost to follow-up before the first BM were censored.

Group	Value	95% CI
Pooled Placebo	27.2	12.4 – NA
Naldemedine 0.01 mg	28.4	25.8 – 43.0
Naldemedine 0.03 mg	13.9	8.2 – NA
Naldemedine 0.1 mg	25.1	3.3 – 57.3
Naldemedine 0.3 mg	4.7	2.8 – 6.2
Naldemedine 1 mg	1.4	1.0 – 2.3
Naldemedine 3 mg	0.7	0.6 – 0.8

Time to First Complete Spontaneous Bowel Movement Secondary · From first dose on Day 15 through Day 17

The time to first CSBM during the Study Drug Administration Period was summarized using Kaplan-Meier estimates. Each participant's first CSBM was counted as an event and the time to first CSBM after dosing was calculated from the date and time of first dosing until the date and time of first CSBM. Participants who dropped out or were lost to follow-up before the first CSBM were censored.

Group	Value	95% CI
Pooled Placebo	NA	NA – NA
Naldemedine 0.01 mg	NA	37.0 – NA
Naldemedine 0.03 mg	NA	37.7 – NA
Naldemedine 0.1 mg	NA	NA – NA
Naldemedine 0.3 mg	NA	NA – NA
Naldemedine 1 mg	1.7	1.3 – 2.3
Naldemedine 3 mg	0.8	0.6 – 25.8

Change From Baseline in Straining During Bowel Movements Secondary · Baseline, 24 hours post-dose and 48 hours post-dose

Straining during BMs was graded using the following scale: 0 = Absent; 1 = Mild; 2 = Moderate; 3 = Severe; 4 = Very Severe. Baseline was defined as the average straining score of all BMs prior to receiving study drug (Day 1 to Day 15). The straining score at 24 and 48 hours post-dose was calculated as the average straining score from all bowel movements from 0 to 24 and 0 to 48 hours post-dose, respectively.

Baseline

Group	Value	95% CI
Pooled Placebo	2.2	± 0.71
Naldemedine 0.01 mg	2.0	± 0.78
Naldemedine 0.03 mg	2.2	± 0.68
Naldemedine 0.1 mg	1.9	± 0.90
Naldemedine 0.3 mg	2.0	± 1.08
Naldemedine 1 mg	2.5	± 0.97
Naldemedine 3 mg	1.7	± 0.99

Change from Baseline to 24 hours post-dose

Group	Value	95% CI
Pooled Placebo	0.8	± 0.76
Naldemedine 0.01 mg	-0.8	± NA
Naldemedine 0.03 mg	-0.2	± 0.88
Naldemedine 0.1 mg	-0.7	± 0.43
Naldemedine 0.3 mg	-0.1	± 0.89
Naldemedine 1 mg	-0.5	± 1.37
Naldemedine 3 mg	-0.9	± 1.64

Change from Baseline to 48 hours post-dose

Group	Value	95% CI
Pooled Placebo	0.5	± 0.87
Naldemedine 0.01 mg	0.2	± 0.74
Naldemedine 0.03 mg	0.4	± 0.80
Naldemedine 0.1 mg	-0.6	± 0.67
Naldemedine 0.3 mg	0.1	± NA
Naldemedine 1 mg	-0.4	± 0.42
Naldemedine 3 mg	-1.4	± 1.40

Change From Baseline to 24 Hours Post-dose in Number of Complete Bowel Movements Per Day Secondary · Baseline and 24 hours post-dose

A complete bowel movement (CBM) was defined as a bowel movement that resulted in a sensation of complete evacuation based on the question "Did you have a feeling of complete emptying after the bowel movement?" Baseline was defined as the average number of CBMs per day prior to receiving study drug (Day 1 to Day 15).

Baseline

Group	Value	95% CI
Pooled Placebo	0.13	± 0.16
Naldemedine 0.01 mg	0.13	± 0.14
Naldemedine 0.03 mg	0.11	± 0.09
Naldemedine 0.1 mg	0.14	± 0.12
Naldemedine 0.3 mg	0.04	± 0.06
Naldemedine 1 mg	0.12	± 0.15
Naldemedine 3 mg	0.19	± 0.15

24 hours post-dose

Group	Value	95% CI
Pooled Placebo	0.06	± 0.24
Naldemedine 0.01 mg	0.00	± 0.00
Naldemedine 0.03 mg	0.11	± 0.33
Naldemedine 0.1 mg	0.22	± 0.44
Naldemedine 0.3 mg	0.11	± 0.33
Naldemedine 1 mg	2.44	± 2.55
Naldemedine 3 mg	3.00	± 3.20

Change from baseline to 24 hours post-dose

Group	Value	95% CI
Pooled Placebo	-0.07	± 0.20
Naldemedine 0.01 mg	-0.13	± 0.14
Naldemedine 0.03 mg	0.01	± 0.31
Naldemedine 0.1 mg	0.09	± 0.45
Naldemedine 0.3 mg	0.07	± 0.35
Naldemedine 1 mg	2.32	± 2.61
Naldemedine 3 mg	2.81	± 3.21

Adverse events — posted to ClinicalTrials.gov

Time frame: From first dose of study drug on Day 15 up to Day 24 (10 days).. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Pooled Placebo

Serious: 0/18 (0%)

Deaths: —

Naldemedine 0.01 mg

Serious: 0/9 (0%)

Deaths: —

Naldemedine 0.03 mg

Serious: 0/9 (0%)

Deaths: —

Naldemedine 0.1 mg

Serious: 0/9 (0%)

Deaths: —

Naldemedine 0.3 mg

Serious: 0/9 (0%)

Deaths: —

Naldemedine 1 mg

Serious: 0/9 (0%)

Deaths: —

Naldemedine 3 mg

Serious: 0/9 (0%)

Deaths: —

Other adverse events (53 terms — click to expand)

Reaction	System	Pooled Placebo	Naldemedine 0.01 mg	Naldemedine 0.03 mg	Naldemedine 0.1 mg	Naldemedine 0.3 mg	Naldemedine 1 mg	Naldemedine 3 mg
Abdominal pain	Gastrointestinal disorders	—	—	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—	—	—
Chills	General disorders	—	—	—	—	—	—	—
Hyperhidrosis	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—
Oxygen saturation decreased	Investigations	—	—	—	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—	—	—
Flatulence	Gastrointestinal disorders	—	—	—	—	—	—	—
Abdominal pain upper	Gastrointestinal disorders	—	—	—	—	—	—	—
Retching	Gastrointestinal disorders	—	—	—	—	—	—	—
Cardiac murmur	Investigations	—	—	—	—	—	—	—
Pallor	Vascular disorders	—	—	—	—	—	—	—
Abdominal discomfort	Gastrointestinal disorders	—	—	—	—	—	—	—
Abdominal distension	Gastrointestinal disorders	—	—	—	—	—	—	—
Dyspepsia	Gastrointestinal disorders	—	—	—	—	—	—	—
Abdominal tenderness	Gastrointestinal disorders	—	—	—	—	—	—	—
Eructation	Gastrointestinal disorders	—	—	—	—	—	—	—
Tongue discolouration	Gastrointestinal disorders	—	—	—	—	—	—	—
Proctalgia	Gastrointestinal disorders	—	—	—	—	—	—	—
Oedema peripheral	General disorders	—	—	—	—	—	—	—
Drug withdrawal syndrome	General disorders	—	—	—	—	—	—	—
Fatigue	General disorders	—	—	—	—	—	—	—
Pyrexia	General disorders	—	—	—	—	—	—	—
Venipuncture site thrombosis	General disorders	—	—	—	—	—	—	—
Infusion site rash	General disorders	—	—	—	—	—	—	—
Cold sweat	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—
Rash	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—
Lethargy	Nervous system disorders	—	—	—	—	—	—	—
Hypoaesthesia	Nervous system disorders	—	—	—	—	—	—	—
Migraine	Nervous system disorders	—	—	—	—	—	—	—
Paraesthesia	Nervous system disorders	—	—	—	—	—	—	—
Somnolence	Nervous system disorders	—	—	—	—	—	—	—
Blood glucose decreased	Investigations	—	—	—	—	—	—	—
Blood prolactin increased	Investigations	—	—	—	—	—	—	—
Heart rate irregular	Investigations	—	—	—	—	—	—	—
Weight decreased	Investigations	—	—	—	—	—	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—

Data from ClinicalTrials.gov NCT01122030 adverse events section.

Sponsor's own description

The primary objective of the study is to evaluate the safety of single doses of oral naldemedine in adults physically dependent on opioids.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Opioid-induced constipation: advances and clinical guidance.
Nelson AD, Camilleri M. · · 2016 · cited 70× · PMID 26977281 · DOI 10.1177/2040622315627801
Naldemedine (Symproic) for the Treatment Of Opioid-Induced Constipation.
Hu K, Bridgeman MB. · · 2018 · cited 11× · PMID 30271103

Verify or expand the search:

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NCT07012005 — Study of BPN14770 in Participants With Severe Renal Impairment and Healthy Controls · Phase 1 · completed

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ClinicalTrials.gov — authoritative US registry record
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Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01122030 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Shionogi
Last refreshed: 30 May 2017

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01122030.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT01122030

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Sponsor's own description

Publications & conference data

Related trials

Other trials of Naldemedine

Other Shionogi trials

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