NCT03054506

The Effect of CSP01 on Chronic Idiopathic Constipation and Irritable Bowel Syndrome With Constipation

Completed NA Results posted Last updated 20 August 2019

What this trial tests

NA trial testing CSP01 in Constipation in 52 participants. Completed in 1 February 2019.

Timeline

7 March 2017

Primary endpoint
10 May 2018

1 February 2019

Quick facts

Lead sponsor	Massachusetts General Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	52
Start date	7 March 2017
Primary completion	10 May 2018
Estimated completion	1 February 2019
Sites	1 location across United States

Drugs / interventions tested

• CSP01
• Carboxymethylcellulose (CMC)
• Placebo

Conditions studied

• Constipation — all drugs for Constipation →
• Chronic Idiopathic Constipation — all drugs for Chronic Idiopathic Constipation →
• Irritable Bowel Syndrome With Constipation — all drugs for Irritable Bowel Syndrome With Constipation →

Sponsor

Massachusetts General Hospital

Who can join

Adults 22 to 70, any sex, with Constipation or Chronic Idiopathic 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.

Change From Baseline in Colonic Transit Time (CTT) Primary · Up to 1 week; measured once during the run-in-period and again during third week of the treatment period

Colonic Transit Time is the amount of time (in minutes) that the SmartPill capsule spent in the large intestine before expulsion. We measured the difference between CTT pre-treatment and post-treatment and calculated the mean difference for each treatment group. Negative values equal a reduction in CTT.

Group	Value	95% CI
CSP01	-727	± 1277
Carboxymethylcellulose (CMC)	-15	± 2226
Placebo	366	± 1714

Complete Spontaneous Bowel Movement (CSBM) Frequency Rate Secondary · 55 days (baseline, treatment, & follow-up)

Average number of Complete Spontaneous Bowel Movements per day (BMs where participant felt that they emptied their bowels). More CSBMs are interpreted as a better outcome.

Pre-treatment

Group	Value	95% CI
CSP01	0.2	± 0.2
Carboxymethylcellulose (CMC)	0.2	± 0.2
Placebo	0.2	± 0.3

Post-treatment

Group	Value	95% CI
CSP01	0.3	± 0.3
Carboxymethylcellulose (CMC)	0.3	± 0.2
Placebo	0.3	± 0.3

Stool Consistency Secondary · 55 days (baseline, treatment, & follow-up)

Stool consistency for each bowel movement based on the Bristol Stool Scale A descriptive numerical scale from 1 to 7 where lower numbers indicate constipation, numbers toward the middle indicate normal stool consistence, and the highest numbers indicate diarrhea. Therefore middle scores mean a better outcome 1= hard lumps 2 = lumpy sausage 3 = cracked sausage 4 = smooth sausage 5 = soft lumps 6 = mushy 7 = watery

Pre-treatment

Group	Value	95% CI
CSP01	3.62	± 0.56
Carboxymethylcellulose (CMC)	3.54	± 0.45
Placebo	3.88	± 0.65

Post-treatment

Group	Value	95% CI
CSP01	3.81	± 0.44
Carboxymethylcellulose (CMC)	3.62	± 0.59
Placebo	3.59	± 0.63

Ease of Passage Rating Secondary · 55 days (baseline, treatment, & follow-up)

Patient assessment of the ease with which bowel movements are passed using a descriptive numerical scale where lower numbers indicate difficult passage of stool, numbers toward the middle indicate more normal passage of stool, and numbers on the highest end indicate abnormally urgent passage of stool. Middle scores indicate a better outcome. 1. = manual disimpaction needed 2. = enema needed 3. = straining needed 4. = normal 5. = urgent without pain 6. = urgent with pain 7. = incontinent

Pre-treatment

Group	Value	95% CI
CSP01	3.62	± 0.56
Carboxymethylcellulose (CMC)	3.54	± 0.45
Placebo	3.88	± 0.65

Post-treatment

Group	Value	95% CI
CSP01	3.81	± 0.44
Carboxymethylcellulose (CMC)	3.62	± 0.59
Placebo	3.59	± 0.63

Patient's Assessment of Abdominal Discomfort Secondary · 55 days (baseline, treatment, & follow-up)

Patient's daily assessment of abdominal discomfort using a numerical rating scale of 0 to 10, where 0 = no discomfort at all and 10 = severe discomfort. Higher scores mean a worse outcome.

Pre-treatment

Group	Value	95% CI
CSP01	3.91	± 1.75
Carboxymethylcellulose (CMC)	3.55	± 1.43
Placebo	3.82	± 2.23

Post-treatment

Group	Value	95% CI
CSP01	3.67	± 1.91
Carboxymethylcellulose (CMC)	3.08	± 1.41
Placebo	3.58	± 2.60

Patient Assessment of Bloating Severity Secondary · 55 days (baseline, treatment, & follow-up)

Patient's daily assessment of bloating severity using a numerical rating scale from 0 to 10 where 0 = no bloating at all and 10 = severe bloating. Higher scores mean a worse outcome.

Pre-treatment

Group	Value	95% CI
CSP01	4.36	± 2.20
Carboxymethylcellulose (CMC)	4.43	± 1.42
Placebo	4.67	± 2.47

Post-treatment

Group	Value	95% CI
CSP01	4.17	± 2.22
Carboxymethylcellulose (CMC)	3.89	± 1.16
Placebo	3.98	± 2.80

Patient Assessment of Constipation Severity Secondary · 55 days (baseline, treatment, & follow-up)

Patient's daily assessment of constipation severity using a numerical rating scale from 0 to 10 where 0 = no constipation at all and 10 = severe constipation. Higher numbers mean a worse outcome.

Pre-treatment

Group	Value	95% CI
CSP01	4.11	± 2.06
Carboxymethylcellulose (CMC)	4.04	± 1.34
Placebo	4.15	± 2.53

Post-treatment

Group	Value	95% CI
CSP01	3.46	± 1.77
Carboxymethylcellulose (CMC)	3.29	± 1.15
Placebo	3.85	± 2.50

Relief Rating Secondary · 55 days (baseline, treatment, & follow-up)

Patient's feeling of overall relief after each bowel movement using a numerical rating scale from 0 to 10 where 0 = no relief and 10 = complete relief. Higher scores mean a better outcome (feeling more relief after a bowel movement).

Pre-treatment

Group	Value	95% CI
CSP01	4.27	± 1.95
Carboxymethylcellulose (CMC)	4.21	± 1.91
Placebo	4.11	± 1.78

Post-treatment

Group	Value	95% CI
CSP01	5.11	± 2.29
Carboxymethylcellulose (CMC)	4.86	± 1.99
Placebo	4.38	± 1.79

Patient Assessment of Constipation - Symptoms (PAC-SYM) Secondary · Day -14 to Day 22

Patient assessment of constipation symptom severity questionnaire. A validated 12-question questionnaire. Numerical scale from 0 to 4 where 0 = absent and 4 = very severe. Possible total score ranges from 0 to 48. Higher total PAC-SYM scores mean a worse outcome. PAC-SYM was completed at four time-points (Day -14, Day 0, Day 15, \& Day 22). Scores were aggregated based on time period as either pre- (Day -14 \& Day 0) or post- (Day 15 \& Day 22) treatment start. Values reported are averages based on patient total scores from these time points. Data was specifically analyzed based on patient d

Pre-treatment (CIC Group)

Group	Value	95% CI
CSP01	17.62	± 6.98
Carboxymethylcellulose (CMC)	17.56	± 4.90
Placebo	12.75	± 6.85

Post-treatment (CIC Group)

Group	Value	95% CI
CSP01	11.77	± 7.43
Carboxymethylcellulose (CMC)	9.22	± 4.09
Placebo	10.25	± 3.86

Pre-treatment (IBS Group)

Group	Value	95% CI
CSP01	18.67	± 11.08
Carboxymethylcellulose (CMC)	17.00	± 4.24
Placebo	17.40	± 7.30

Post-treatment (IBS Group)

Group	Value	95% CI
CSP01	13.17	± 7.41
Carboxymethylcellulose (CMC)	16.00	± 4.24
Placebo	15.20	± 10.18

Patient Assessment of Constipation - Quality of Life (PAC-QOL) Secondary · Day -14 to Day 22

Patient Assessment of Constipation Quality of Life Questionnaire. A validated questionnaire containing 28 total questions with four sub-sections each broadly ranging from "not at all" to "all of the time" on 0 to 4 scales. Possible total range is 0 to 112. An overall higher total score on the PAC-QOL means a worse outcome. PAC-QOL was completed at four time-points (Day -14, Day 0, Day 15, \& Day 22). Scores were aggregated based on time period as either pre- (Day -14 \& Day 0) or post- (Day 15 \& Day 22) treatment start. Values reported are averages based on patient total scores from these ti

Pre-treatment (CIC Group)

Group	Value	95% CI
CSP01	39.08	± 17.09
Carboxymethylcellulose (CMC)	31.22	± 6.57
Placebo	26.50	± 14.25

Post-treatment (CIC Group)

Group	Value	95% CI
CSP01	26.46	± 18.30
Carboxymethylcellulose (CMC)	20.56	± 4.42
Placebo	19.75	± 6.99

Pre-treatment (IBS Group)

Group	Value	95% CI
CSP01	41.00	± 17.01
Carboxymethylcellulose (CMC)	32.00	± 4.24
Placebo	34.30	± 14.48

Post-treatment (IBS Group)

Group	Value	95% CI
CSP01	30.33	± 20.20
Carboxymethylcellulose (CMC)	23.00	± 1.41
Placebo	35.60	± 8.53

Need for Rescue Laxatives Secondary · 55 days (baseline, treatment, & follow-up)

Number of total days that rescue laxatives were used by participants in each treatment group. (The number of days that rescue laxatives were used by each individual patient was calculated and added to the treatment group total)

Group	Value	95% CI
CSP01	13
Carboxymethylcellulose (CMC)	6
Placebo	3

Spontaneous Bowel Movement (SBM) Frequency Secondary · 55 days (baseline, treatment, & follow-up)

Average number of Spontaneous Bowel Movements per day. (Spontaneous Bowel Movements include both complete and incomplete bowel movements)

Pre-treatment

Group	Value	95% CI
CSP01	0.75	± 0.29
Carboxymethylcellulose (CMC)	0.70	± 0.40
Placebo	0.75	± 0.39

Post-treatment

Group	Value	95% CI
CSP01	0.95	± 0.36
Carboxymethylcellulose (CMC)	0.79	± 0.35
Placebo	0.89	± 0.58

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse event data was collected for each subject throughout the study duration, from study enrollment to final day in study (includes 9-day follow-up period). Study duration was approximately 46-59 days.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

CSP01

Serious: 0/20 (0%)

Deaths: 0/20

Carboxymethylcellulose (CMC)

Serious: 0/11 (0%)

Deaths: 0/11

Placebo

Serious: 0/9 (0%)

Deaths: 0/9

Other adverse events (1 terms — click to expand)

Reaction	System	CSP01	Carboxymethylcellulose (CMC)	Placebo
Constipation and back pain caused by constipation	Gastrointestinal disorders	—	—	—

Data from ClinicalTrials.gov NCT03054506 adverse events section.

Sponsor's own description

Constipation is a common gastrointestinal motility disorder that is often chronic, negatively affects patients' daily lives. Constipation occurs when bowel movements become difficult or less frequent.This study is being done to study the effectiveness of the hydrogel capsule, CSP01, compared to the active control (carboxymethylcellulose) and placebo (non-medicine sugar pill), to relieve constipation among subjects with chronic idiopathic constipation (CIC) or with irritable bowel syndrome with constipation (IBS-C).

Publications & conference data

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

1. CSP01, a Novel Superabsorbent Hydrogel, Reduces Colonic Transit Time in Patients With Chronic Idiopathic Constipation in a Randomized, Double-blind, Controlled Pilot Clinical Trial.
   Staller K, Barshop K, Vélez C, Bailey A, et al · · 2020 · cited 1× · PMID 32807749 · DOI 10.5056/jnm20001