NCT03060512

To Evaluate Patient Preference of Movantik and Polyethylene Glycol 3350 for Opioid Induced Constipation

Completed Phase 4 Results posted Last updated 13 July 2018

What this trial tests

Phase 4 trial testing Polyethylene Glycol 3350 in Opioid Induced Constipation in 276 participants. Completed in 23 August 2017.

Timeline

2 March 2017

Primary endpoint
23 August 2017

23 August 2017

Quick facts

Lead sponsor	AstraZeneca
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	276
Start date	2 March 2017
Primary completion	23 August 2017
Estimated completion	23 August 2017
Sites	53 locations across United States

Drugs / interventions tested

• Polyethylene Glycol 3350 — full drug profile →
• Movantik (NALOXEGOL) — full drug profile →

Conditions studied

• Opioid Induced Constipation — all drugs for Opioid Induced Constipation →

Sponsor

AstraZeneca — full company profile →

Who can join

Adults 18 to 84, any sex, with Opioid Induced Constipation. 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.

Patient Reported Preference for Movantik or PEG 3350 for Opioid-induced Constipation (OIC) Treatment Primary · From Visit 2 (Day 1) of Treatment Period 1 to Visit 5 (Day 36) of Treatment Period 2 (end of study).

The Patient Preference Assessment was conducted at Visit 5 using a 7-point scale in subjects with chronic non-cancer pain. The 3 categories were formed by collapsing the 7-point rating scale to: 1. Prefer Movantik (including Strong preference for Movantik, Moderate preference for Movantik, Slight preference for Movantik), 2. No preference, and 3. Prefer PEG 3350 (including Strong preference for PEG 3350, Moderate preference for PEG 3350, and Slight preference for PEG 3350). The number of subjects in each category is presented for the total number of subjects in the Per-Protocol (PP) Set.

Prefer Movantik

Group	Value	95% CI
Total (PP Set)	124

Prefer PEG 3350

Group	Value	95% CI
Total (PP Set)	118

No preference

Group	Value	95% CI
Total (PP Set)	4

Patient Reported Preference for Movantik or PEG 3350 for OIC Treatment by Treatment Sequence Primary · From Visit 2 (Day 1) of Treatment Period 1 to Visit 5 (Day 36) of Treatment Period 2 (end of study).

The Patient Preference Assessment was conducted at Visit 5 using a 7-point scale in subjects with chronic non-cancer pain. The following categories were the possible responses: Strong preference for Movantik, Moderate preference for Movantik, Slight preference for Movantik, No preference, Slight preference for PEG 3350, Moderate preference for PEG 3350 and Strong preference for PEG 3350. Prefer Movantik included subjects in the categories Strong preference for Movantik, Moderate preference for Movantik and Slight preference for Movantik. Prefer PEG 3350 included subjects in the categories Stro

Strong preference for Movantik

Group	Value	95% CI
Movantik, Then PEG 3350	37
PEG 3350, Then Movantik	38

Moderate preference for Movantik

Group	Value	95% CI
Movantik, Then PEG 3350	14
PEG 3350, Then Movantik	17

Slight preference for Movantik

Group	Value	95% CI
Movantik, Then PEG 3350	11
PEG 3350, Then Movantik	7

No preference

Group	Value	95% CI
Movantik, Then PEG 3350	2
PEG 3350, Then Movantik	2

Slight preference for PEG 3350

Group	Value	95% CI
Movantik, Then PEG 3350	9
PEG 3350, Then Movantik	8

Moderate preference for PEG 3350

Group	Value	95% CI
Movantik, Then PEG 3350	15
PEG 3350, Then Movantik	23

Strong preference for PEG 3350

Group	Value	95% CI
Movantik, Then PEG 3350	37
PEG 3350, Then Movantik	26

Prefer Movantik

Group	Value	95% CI
Movantik, Then PEG 3350	62
PEG 3350, Then Movantik	62

Patient Reported Influence of Each Medication Characteristic Median Scores That Contributed to Their Overall Preference for Movantik or PEG 3350 Secondary · From Visit 2 (Day 1) of Treatment Period 1 to Visit 5 (Day 36) of Treatment Period 2 (end of study).

In order to assess the reason for patient preference of Movantik or PEG 3350, subjects reported on the influence of 5 medication characteristics using a 4-point rating scale. The following were the scale options: efficacy ('worked better to relieve my OIC'), tolerability ('tolerated better'), convenience ('was more convenient'), works quickly ('worked quickly') and works predictably ('worked predictably'). For each characteristic, influence scores were rated as: 0 = No influence, 1 = Mildly influenced, 2 = Moderately influenced or 3 = Strongly influenced. The scale range for each characteristi

Worked better to relieve my OIC

Group	Value	95% CI
Preferred Movantik	2.0	0 – 3
Preferred PEG 3350	2.0	0 – 3

Tolerated better

Group	Value	95% CI
Preferred Movantik	3.0	0 – 3
Preferred PEG 3350	3.0	0 – 3

Was more convenient

Group	Value	95% CI
Preferred Movantik	3.0	0 – 3
Preferred PEG 3350	1.0	0 – 3

Worked quickly

Group	Value	95% CI
Preferred Movantik	2.0	0 – 3
Preferred PEG 3350	2.0	0 – 3

Worked predictably

Group	Value	95% CI
Preferred Movantik	2.0	0 – 3
Preferred PEG 3350	2.0	0 – 3

Patient Reported Influence of Each Medication Characteristic Individual Category Results That Contributed to Their Overall Preference for Movantik or PEG 3350 Secondary · From Visit 2 (Day 1) of Treatment Period 1 to Visit 5 (Day 36) of Treatment Period 2 (end of study).

In order to assess the reason for patient preference of Movantik or PEG 3350, subjects reported on the influence of 5 medication characteristics using a 4-point rating scale. The following were the scale options: efficacy ('worked better to relieve my OIC'), tolerability ('tolerated better'), convenience ('was more convenient'), works quickly ('worked quickly') and works predictably ('worked predictably'). For each characteristic, influence scores were rated as: 0 = No influence, 1 = Mildly influenced, 2 = Moderately influenced or 3 = Strongly influenced. The scale range for each characteristi

Efficacy: No Influence

Group	Value	95% CI
Preferred Movantik	4
Preferred PEG 3350	2

Efficacy: Mildly Influenced

Group	Value	95% CI
Preferred Movantik	18
Preferred PEG 3350	20

Efficacy: Moderately Influenced

Group	Value	95% CI
Preferred Movantik	40
Preferred PEG 3350	43

Efficacy: Strongly Influenced

Group	Value	95% CI
Preferred Movantik	61
Preferred PEG 3350	52

Tolerability: No Influence

Group	Value	95% CI
Preferred Movantik	14
Preferred PEG 3350	15

Tolerability: Mildly Influenced

Group	Value	95% CI
Preferred Movantik	16
Preferred PEG 3350	11

Tolerability: Moderately Influenced

Group	Value	95% CI
Preferred Movantik	30
Preferred PEG 3350	32

Tolerability: Strongly Influenced

Group	Value	95% CI
Preferred Movantik	63
Preferred PEG 3350	59

Patient Global Impression of Change (PGIC) Questionnaire to Compare the Impact of Movantik and PEG 3350 on OIC Symptoms Secondary · At Visit 3 (Day 15) of Treatment Period 1 and Visit 5 (Day 36) of Treatment Period 2.

PGIC was measured on a 7-point scale at the end of each two-week treatment period to assess the subject's impression of the effectiveness of the treatment received for OIC. The scoring was as follows: 1 = No change (or condition has gotten worse); 2 = Almost the same, hardly any change at all; 3 = A little better, but no noticeable change; 4 = Somewhat better, but the change has not made any real difference; 5 = Moderately better, and a slight but noticeable change; 6 = Better and a definite improvement that has made a real and worthwhile difference; and 7 = A great deal better and a considera

Group	Value	95% CI
Movantik FAS	4.5	± 1.83
PEG 3350 FAS	4.5	± 1.83

PGIC Questionnaire Individual Item Results to Compare the Impact of Movantik and PEG 3350 on OIC Symptoms Secondary · At Visit 3 (Day 15) of Treatment Period 1 and Visit 5 (Day 36) of Treatment Period 2.

PGIC was measured on a 7-point scale at the end of each two-week treatment period to assess the subject's impression of the effectiveness of the treatment received for OIC. The subjects selected one of the following PGIC items as their response: 1 = No change (or condition has gotten worse); 2 = Almost the same, hardly any change at all; 3 = A little better, but no noticeable change; 4 = Somewhat better, but the change has not made any real differences; 5 = Moderately better, and a slight but noticeable change; 6 = Better and a definite improvement that has made a real and worthwhile differenc

PGIC Item 1

Group	Value	95% CI
Movantik FAS	23
PEG 3350 FAS	27

PGIC Item 2

Group	Value	95% CI
Movantik FAS	30
PEG 3350 FAS	27

PGIC Item 3

Group	Value	95% CI
Movantik FAS	21
PEG 3350 FAS	20

PGIC Item 4

Group	Value	95% CI
Movantik FAS	38
PEG 3350 FAS	33

PGIC Item 5

Group	Value	95% CI
Movantik FAS	57
PEG 3350 FAS	66

PGIC Item 6

Group	Value	95% CI
Movantik FAS	61
PEG 3350 FAS	65

PGIC Item 7

Group	Value	95% CI
Movantik FAS	32
PEG 3350 FAS	28

Mean Change From Baseline at Visit 3/5 in Bowel Function Index (BFI) Questionnaire Scores to Compare the Impact of Movantik and PEG 3350 on OIC Symptoms Secondary · From Baseline (Visit 2, Day 1) to Visit 3 (Day 15) and Visit 5 (Day 36).

The BFI is a 3-item questionnaire administered by a study clinician to measure constipation from the subject's perspective (ease of defecation, feeling of complete evacuation, and personal judgment of constipation). For each item the subject was asked to rate their response on a scale from 0 to 100, where 0 indicates the best response (easy/no diffculty) and 100 the worst response (severe difficulty). The total BFI score was calculated as the mean of the 3 item scores. The mean change from baseline in BFI scores at Visits 3 and/or 5 are presented.

Group	Value	95% CI
Movantik FAS	-25.0	± 31.64
PEG 3350 FAS	-26.0	± 28.82

Adverse events — posted to ClinicalTrials.gov

Time frame: Approximately 5 weeks.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Movantik

Serious: 3/271 (1%)

Deaths: 0/271

PEG 3350

Serious: 1/268 (0%)

Deaths: 0/268

Serious adverse events (6 terms)

Reaction	System	Movantik	PEG 3350
Gastroenteritis	Infections and infestations	—	—
Cardiac failure congestive	Cardiac disorders	—	—
Diarrhoea	Gastrointestinal disorders	—	—
Hypokalaemia	Metabolism and nutrition disorders	—	—
Aphasia	Nervous system disorders	—	—
Salmonellosis	Infections and infestations	—	—

Other adverse events (77 terms — click to expand)

Reaction	System	Movantik	PEG 3350
Abdominal pain	Gastrointestinal disorders	—	—
Abdominal pain upper	Gastrointestinal disorders	—	—
Diarrhoea	Gastrointestinal disorders	—	—
Flatulence	Gastrointestinal disorders	—	—
Headache	Nervous system disorders	—	—
Nausea	Gastrointestinal disorders	—	—
Abdominal distension	Gastrointestinal disorders	—	—
Vertigo	Ear and labyrinth disorders	—	—
Defaecation urgency	Gastrointestinal disorders	—	—
Dry mouth	Gastrointestinal disorders	—	—
Vomiting	Gastrointestinal disorders	—	—
Drug withdrawal syndrome	General disorders	—	—
Non-cardiac chest pain	General disorders	—	—
Bronchitis	Infections and infestations	—	—
Gastroenteritis	Infections and infestations	—	—
Urinary tract infection	Infections and infestations	—	—
Laceration	Injury, poisoning and procedural complications	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—
Dizziness	Nervous system disorders	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—
Lymph node pain	Blood and lymphatic system disorders	—	—
Thrombocytopenia	Blood and lymphatic system disorders	—	—
Atrial fibrillation	Cardiac disorders	—	—
Bradycardia	Cardiac disorders	—	—
Diastolic dysfunction	Cardiac disorders	—	—
Abdominal pain lower	Gastrointestinal disorders	—	—
Abdominal tenderness	Gastrointestinal disorders	—	—
Abnormal faeces	Gastrointestinal disorders	—	—
Enteritis	Gastrointestinal disorders	—	—
Eructation	Gastrointestinal disorders	—	—
Frequent bowel movements	Gastrointestinal disorders	—	—
Rectal haemorrhage	Gastrointestinal disorders	—	—
Toothache	Gastrointestinal disorders	—	—
Influenza like illness	General disorders	—	—
Malaise	General disorders	—	—
Oedema	General disorders	—	—
Abscess limb	Infections and infestations	—	—
Conjunctivitis	Infections and infestations	—	—
Gastroenteritis viral	Infections and infestations	—	—
Hordeolum	Infections and infestations	—	—

Most-reported serious reactions: Gastroenteritis, Cardiac failure congestive, Diarrhoea, Hypokalaemia, Aphasia, Salmonellosis.

Data from ClinicalTrials.gov NCT03060512 adverse events section.

Sponsor's own description

The purpose of this study is to determine whether patients with opioid induced constipation prefer treatment with naloxegol (Movantik) or with Polyethylene Glycol 3350.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. A Randomized, Multicenter, Prospective, Crossover, Open-Label Study of Factors Associated With Patient Preferences for Naloxegol or PEG 3350 for Opioid-Induced Constipation.
   Brenner DM, Hu Y, Datto C, Creanga D, et al · · 2019 · cited 8× · PMID 31058652 · DOI 10.14309/ajg.0000000000000229