Trial Outcomes & Findings for The Effect of CSP01 on Chronic Idiopathic Constipation and Irritable Bowel Syndrome With Constipation (NCT NCT03054506)
NCT ID: NCT03054506
Last Updated: 2019-08-20
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
52 participants
Primary outcome timeframe
Up to 1 week; measured once during the run-in-period and again during third week of the treatment period
Results posted on
2019-08-20
Participant Flow
52 patients signed the consent form and thus were considered enrolled. 4 failed screening 48 passed screening 5 withdrew before run-in 1 lost to follow-up 42 started run-in 2 failed run-in 40 randomized 1 withdrew due to AE 39 completed study 1 patient's follow-up CTT data irretrievable (technical malfunction) 38 complete CTTs
Participant milestones
| Measure |
CSP01
Subjects in the experimental group will receive CSP01, a non-systemic, orally administered hydrogel capsule, twice a day. CSP01 capsules are taken prior to a meal with water, after which the small particles within the capsules hydrate and expand in the stomach and small intestine. By acting as a bulking agent and possibly reducing colonic transit time through increase of colonic water content, CSP01 may contribute to constipation relief.
CSP01: Subjects will take three capsules in the morning before breakfast, and three capsules at night before dinner each day for three weeks.
|
Carboxymethylcellulose (CMC)
Subjects in the active control group will receive orally administered 3 capsules of carboxymethylcellulose (CMC) capsules twice a day.
Carboxymethylcellulose (CMC): Subjects will take three capsules in the morning before breakfast, and three capsules at night before dinner each day for three weeks.
|
Placebo
Matching placebo consists of an inert mixture supplied by Gelesis Inc. in identical-appearing capsules.Subjects in the placebo group will be administered 3 capsules of placebo twice a day.
Placebo: Subjects will take three capsules in the morning before breakfast, and three capsules at night before dinner each day for three weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
20
|
11
|
9
|
|
Overall Study
COMPLETED
|
19
|
11
|
9
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Effect of CSP01 on Chronic Idiopathic Constipation and Irritable Bowel Syndrome With Constipation
Baseline characteristics by cohort
| Measure |
CSP01
n=20 Participants
Subjects in the experimental group will receive CSP01, a non-systemic, orally administered hydrogel capsule, twice a day. CSP01 capsules are taken prior to a meal with water, after which the small particles within the capsules hydrate and expand in the stomach and small intestine. By acting as a bulking agent and possibly reducing colonic transit time through increase of colonic water content, CSP01 may contribute to constipation relief.
CSP01: Subjects will take three capsules in the morning before breakfast, and three capsules at night before dinner each day for three weeks.
|
Carboxymethylcellulose (CMC)
n=11 Participants
Subjects in the active control group will receive orally administered 3 capsules of carboxymethylcellulose (CMC) capsules twice a day.
Carboxymethylcellulose (CMC): Subjects will take three capsules in the morning before breakfast, and three capsules at night before dinner each day for three weeks.
|
Placebo
n=9 Participants
Matching placebo consists of an inert mixture supplied by Gelesis Inc. in identical-appearing capsules.Subjects in the placebo group will be administered 3 capsules of placebo twice a day.
Placebo: Subjects will take three capsules in the morning before breakfast, and three capsules at night before dinner each day for three weeks.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
11 participants
n=7 Participants
|
9 participants
n=5 Participants
|
40 participants
n=4 Participants
|
|
Diagnosis: CIC, IBS-C
Chronic Idiopathic Constipation
|
14 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
|
Diagnosis: CIC, IBS-C
Irritable Bowel Syndrome with Constipation
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Up to 1 week; measured once during the run-in-period and again during third week of the treatment periodPopulation: All participants who completed the study. (39 participants) Note: One participant who received placebo had pre-treatment CTT data, but post-treatment CTT data was irretrievable due to technical malfunction. This subject's pre-treatment CTT data is included in analysis, but no post-treatment CTT data.
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.
Outcome measures
| Measure |
CSP01
n=19 Participants
Subjects in the experimental group will receive CSP01, a non-systemic, orally administered hydrogel capsule, twice a day. CSP01 capsules are taken prior to a meal with water, after which the small particles within the capsules hydrate and expand in the stomach and small intestine. By acting as a bulking agent and possibly reducing colonic transit time through increase of colonic water content, CSP01 may contribute to constipation relief.
CSP01: Subjects will take three capsules in the morning before breakfast, and three capsules at night before dinner each day for three weeks.
|
Carboxymethylcellulose (CMC)
n=11 Participants
Subjects in the active control group will receive orally administered 3 capsules of carboxymethylcellulose (CMC) capsules twice a day.
Carboxymethylcellulose (CMC): Subjects will take three capsules in the morning before breakfast, and three capsules at night before dinner each day for three weeks.
|
Placebo
n=9 Participants
Matching placebo consists of an inert mixture supplied by Gelesis Inc. in identical-appearing capsules.Subjects in the placebo group will be administered 3 capsules of placebo twice a day.
Placebo: Subjects will take three capsules in the morning before breakfast, and three capsules at night before dinner each day for three weeks.
|
|---|---|---|---|
|
Change From Baseline in Colonic Transit Time (CTT)
|
-727 minutes
Standard Deviation 1277
|
-15 minutes
Standard Deviation 2226
|
366 minutes
Standard Deviation 1714
|
SECONDARY outcome
Timeframe: 55 days (baseline, treatment, & follow-up)Population: All participants who completed the study and had both pre and post treatment CSBM measurement
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.
Outcome measures
| Measure |
CSP01
n=19 Participants
Subjects in the experimental group will receive CSP01, a non-systemic, orally administered hydrogel capsule, twice a day. CSP01 capsules are taken prior to a meal with water, after which the small particles within the capsules hydrate and expand in the stomach and small intestine. By acting as a bulking agent and possibly reducing colonic transit time through increase of colonic water content, CSP01 may contribute to constipation relief.
CSP01: Subjects will take three capsules in the morning before breakfast, and three capsules at night before dinner each day for three weeks.
|
Carboxymethylcellulose (CMC)
n=11 Participants
Subjects in the active control group will receive orally administered 3 capsules of carboxymethylcellulose (CMC) capsules twice a day.
Carboxymethylcellulose (CMC): Subjects will take three capsules in the morning before breakfast, and three capsules at night before dinner each day for three weeks.
|
Placebo
n=9 Participants
Matching placebo consists of an inert mixture supplied by Gelesis Inc. in identical-appearing capsules.Subjects in the placebo group will be administered 3 capsules of placebo twice a day.
Placebo: Subjects will take three capsules in the morning before breakfast, and three capsules at night before dinner each day for three weeks.
|
|---|---|---|---|
|
Complete Spontaneous Bowel Movement (CSBM) Frequency Rate
Pre-treatment
|
0.2 number of CSBMs per day
Standard Deviation 0.2
|
0.2 number of CSBMs per day
Standard Deviation 0.2
|
0.2 number of CSBMs per day
Standard Deviation 0.3
|
|
Complete Spontaneous Bowel Movement (CSBM) Frequency Rate
Post-treatment
|
0.3 number of CSBMs per day
Standard Deviation 0.3
|
0.3 number of CSBMs per day
Standard Deviation 0.2
|
0.3 number of CSBMs per day
Standard Deviation 0.3
|
SECONDARY outcome
Timeframe: 55 days (baseline, treatment, & follow-up)Population: All participants who completed the study and had both pre and post treatment stool consistency ratings.
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
Outcome measures
| Measure |
CSP01
n=19 Participants
Subjects in the experimental group will receive CSP01, a non-systemic, orally administered hydrogel capsule, twice a day. CSP01 capsules are taken prior to a meal with water, after which the small particles within the capsules hydrate and expand in the stomach and small intestine. By acting as a bulking agent and possibly reducing colonic transit time through increase of colonic water content, CSP01 may contribute to constipation relief.
CSP01: Subjects will take three capsules in the morning before breakfast, and three capsules at night before dinner each day for three weeks.
|
Carboxymethylcellulose (CMC)
n=11 Participants
Subjects in the active control group will receive orally administered 3 capsules of carboxymethylcellulose (CMC) capsules twice a day.
Carboxymethylcellulose (CMC): Subjects will take three capsules in the morning before breakfast, and three capsules at night before dinner each day for three weeks.
|
Placebo
n=9 Participants
Matching placebo consists of an inert mixture supplied by Gelesis Inc. in identical-appearing capsules.Subjects in the placebo group will be administered 3 capsules of placebo twice a day.
Placebo: Subjects will take three capsules in the morning before breakfast, and three capsules at night before dinner each day for three weeks.
|
|---|---|---|---|
|
Stool Consistency
Pre-treatment
|
3.62 score on a scale
Standard Deviation 0.56
|
3.54 score on a scale
Standard Deviation 0.45
|
3.88 score on a scale
Standard Deviation 0.65
|
|
Stool Consistency
Post-treatment
|
3.81 score on a scale
Standard Deviation 0.44
|
3.62 score on a scale
Standard Deviation 0.59
|
3.59 score on a scale
Standard Deviation 0.63
|
SECONDARY outcome
Timeframe: 55 days (baseline, treatment, & follow-up)Population: All participants who completed the study and had both pre and post treatment ease of passage ratings
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
Outcome measures
| Measure |
CSP01
n=19 Participants
Subjects in the experimental group will receive CSP01, a non-systemic, orally administered hydrogel capsule, twice a day. CSP01 capsules are taken prior to a meal with water, after which the small particles within the capsules hydrate and expand in the stomach and small intestine. By acting as a bulking agent and possibly reducing colonic transit time through increase of colonic water content, CSP01 may contribute to constipation relief.
CSP01: Subjects will take three capsules in the morning before breakfast, and three capsules at night before dinner each day for three weeks.
|
Carboxymethylcellulose (CMC)
n=11 Participants
Subjects in the active control group will receive orally administered 3 capsules of carboxymethylcellulose (CMC) capsules twice a day.
Carboxymethylcellulose (CMC): Subjects will take three capsules in the morning before breakfast, and three capsules at night before dinner each day for three weeks.
|
Placebo
n=9 Participants
Matching placebo consists of an inert mixture supplied by Gelesis Inc. in identical-appearing capsules.Subjects in the placebo group will be administered 3 capsules of placebo twice a day.
Placebo: Subjects will take three capsules in the morning before breakfast, and three capsules at night before dinner each day for three weeks.
|
|---|---|---|---|
|
Ease of Passage Rating
Pre-treatment
|
3.62 score on a scale
Standard Deviation 0.56
|
3.54 score on a scale
Standard Deviation 0.45
|
3.88 score on a scale
Standard Deviation 0.65
|
|
Ease of Passage Rating
Post-treatment
|
3.81 score on a scale
Standard Deviation 0.44
|
3.62 score on a scale
Standard Deviation 0.59
|
3.59 score on a scale
Standard Deviation 0.63
|
SECONDARY outcome
Timeframe: 55 days (baseline, treatment, & follow-up)Population: All participants who completed the study and had both pre and post treatment abdominal discomfort ratings
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.
Outcome measures
| Measure |
CSP01
n=19 Participants
Subjects in the experimental group will receive CSP01, a non-systemic, orally administered hydrogel capsule, twice a day. CSP01 capsules are taken prior to a meal with water, after which the small particles within the capsules hydrate and expand in the stomach and small intestine. By acting as a bulking agent and possibly reducing colonic transit time through increase of colonic water content, CSP01 may contribute to constipation relief.
CSP01: Subjects will take three capsules in the morning before breakfast, and three capsules at night before dinner each day for three weeks.
|
Carboxymethylcellulose (CMC)
n=11 Participants
Subjects in the active control group will receive orally administered 3 capsules of carboxymethylcellulose (CMC) capsules twice a day.
Carboxymethylcellulose (CMC): Subjects will take three capsules in the morning before breakfast, and three capsules at night before dinner each day for three weeks.
|
Placebo
n=9 Participants
Matching placebo consists of an inert mixture supplied by Gelesis Inc. in identical-appearing capsules.Subjects in the placebo group will be administered 3 capsules of placebo twice a day.
Placebo: Subjects will take three capsules in the morning before breakfast, and three capsules at night before dinner each day for three weeks.
|
|---|---|---|---|
|
Patient's Assessment of Abdominal Discomfort
Pre-treatment
|
3.91 score on a scale
Standard Deviation 1.75
|
3.55 score on a scale
Standard Deviation 1.43
|
3.82 score on a scale
Standard Deviation 2.23
|
|
Patient's Assessment of Abdominal Discomfort
Post-treatment
|
3.67 score on a scale
Standard Deviation 1.91
|
3.08 score on a scale
Standard Deviation 1.41
|
3.58 score on a scale
Standard Deviation 2.60
|
SECONDARY outcome
Timeframe: 55 days (baseline, treatment, & follow-up)Population: All participants who completed the study and had both pre and post treatment bloating ratings.
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.
Outcome measures
| Measure |
CSP01
n=19 Participants
Subjects in the experimental group will receive CSP01, a non-systemic, orally administered hydrogel capsule, twice a day. CSP01 capsules are taken prior to a meal with water, after which the small particles within the capsules hydrate and expand in the stomach and small intestine. By acting as a bulking agent and possibly reducing colonic transit time through increase of colonic water content, CSP01 may contribute to constipation relief.
CSP01: Subjects will take three capsules in the morning before breakfast, and three capsules at night before dinner each day for three weeks.
|
Carboxymethylcellulose (CMC)
n=11 Participants
Subjects in the active control group will receive orally administered 3 capsules of carboxymethylcellulose (CMC) capsules twice a day.
Carboxymethylcellulose (CMC): Subjects will take three capsules in the morning before breakfast, and three capsules at night before dinner each day for three weeks.
|
Placebo
n=9 Participants
Matching placebo consists of an inert mixture supplied by Gelesis Inc. in identical-appearing capsules.Subjects in the placebo group will be administered 3 capsules of placebo twice a day.
Placebo: Subjects will take three capsules in the morning before breakfast, and three capsules at night before dinner each day for three weeks.
|
|---|---|---|---|
|
Patient Assessment of Bloating Severity
Post-treatment
|
4.17 score on a scale
Standard Deviation 2.22
|
3.89 score on a scale
Standard Deviation 1.16
|
3.98 score on a scale
Standard Deviation 2.80
|
|
Patient Assessment of Bloating Severity
Pre-treatment
|
4.36 score on a scale
Standard Deviation 2.20
|
4.43 score on a scale
Standard Deviation 1.42
|
4.67 score on a scale
Standard Deviation 2.47
|
SECONDARY outcome
Timeframe: 55 days (baseline, treatment, & follow-up)Population: All participants who completed the study and had both pre and post treatment constipation severity ratings
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.
Outcome measures
| Measure |
CSP01
n=19 Participants
Subjects in the experimental group will receive CSP01, a non-systemic, orally administered hydrogel capsule, twice a day. CSP01 capsules are taken prior to a meal with water, after which the small particles within the capsules hydrate and expand in the stomach and small intestine. By acting as a bulking agent and possibly reducing colonic transit time through increase of colonic water content, CSP01 may contribute to constipation relief.
CSP01: Subjects will take three capsules in the morning before breakfast, and three capsules at night before dinner each day for three weeks.
|
Carboxymethylcellulose (CMC)
n=11 Participants
Subjects in the active control group will receive orally administered 3 capsules of carboxymethylcellulose (CMC) capsules twice a day.
Carboxymethylcellulose (CMC): Subjects will take three capsules in the morning before breakfast, and three capsules at night before dinner each day for three weeks.
|
Placebo
n=9 Participants
Matching placebo consists of an inert mixture supplied by Gelesis Inc. in identical-appearing capsules.Subjects in the placebo group will be administered 3 capsules of placebo twice a day.
Placebo: Subjects will take three capsules in the morning before breakfast, and three capsules at night before dinner each day for three weeks.
|
|---|---|---|---|
|
Patient Assessment of Constipation Severity
Pre-treatment
|
4.11 score on a scale
Standard Deviation 2.06
|
4.04 score on a scale
Standard Deviation 1.34
|
4.15 score on a scale
Standard Deviation 2.53
|
|
Patient Assessment of Constipation Severity
Post-treatment
|
3.46 score on a scale
Standard Deviation 1.77
|
3.29 score on a scale
Standard Deviation 1.15
|
3.85 score on a scale
Standard Deviation 2.50
|
SECONDARY outcome
Timeframe: 55 days (baseline, treatment, & follow-up)Population: All participants who completed the study and had both pre and post treatment relief ratings
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).
Outcome measures
| Measure |
CSP01
n=19 Participants
Subjects in the experimental group will receive CSP01, a non-systemic, orally administered hydrogel capsule, twice a day. CSP01 capsules are taken prior to a meal with water, after which the small particles within the capsules hydrate and expand in the stomach and small intestine. By acting as a bulking agent and possibly reducing colonic transit time through increase of colonic water content, CSP01 may contribute to constipation relief.
CSP01: Subjects will take three capsules in the morning before breakfast, and three capsules at night before dinner each day for three weeks.
|
Carboxymethylcellulose (CMC)
n=11 Participants
Subjects in the active control group will receive orally administered 3 capsules of carboxymethylcellulose (CMC) capsules twice a day.
Carboxymethylcellulose (CMC): Subjects will take three capsules in the morning before breakfast, and three capsules at night before dinner each day for three weeks.
|
Placebo
n=9 Participants
Matching placebo consists of an inert mixture supplied by Gelesis Inc. in identical-appearing capsules.Subjects in the placebo group will be administered 3 capsules of placebo twice a day.
Placebo: Subjects will take three capsules in the morning before breakfast, and three capsules at night before dinner each day for three weeks.
|
|---|---|---|---|
|
Relief Rating
Pre-treatment
|
4.27 score on a scale
Standard Deviation 1.95
|
4.21 score on a scale
Standard Deviation 1.91
|
4.11 score on a scale
Standard Deviation 1.78
|
|
Relief Rating
Post-treatment
|
5.11 score on a scale
Standard Deviation 2.29
|
4.86 score on a scale
Standard Deviation 1.99
|
4.38 score on a scale
Standard Deviation 1.79
|
SECONDARY outcome
Timeframe: Day -14 to Day 22Population: All participants who completed the study and had both pre and post treatment PAC-SYM ratings
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 diagnosis in addition to treatment.
Outcome measures
| Measure |
CSP01
n=19 Participants
Subjects in the experimental group will receive CSP01, a non-systemic, orally administered hydrogel capsule, twice a day. CSP01 capsules are taken prior to a meal with water, after which the small particles within the capsules hydrate and expand in the stomach and small intestine. By acting as a bulking agent and possibly reducing colonic transit time through increase of colonic water content, CSP01 may contribute to constipation relief.
CSP01: Subjects will take three capsules in the morning before breakfast, and three capsules at night before dinner each day for three weeks.
|
Carboxymethylcellulose (CMC)
n=11 Participants
Subjects in the active control group will receive orally administered 3 capsules of carboxymethylcellulose (CMC) capsules twice a day.
Carboxymethylcellulose (CMC): Subjects will take three capsules in the morning before breakfast, and three capsules at night before dinner each day for three weeks.
|
Placebo
n=9 Participants
Matching placebo consists of an inert mixture supplied by Gelesis Inc. in identical-appearing capsules.Subjects in the placebo group will be administered 3 capsules of placebo twice a day.
Placebo: Subjects will take three capsules in the morning before breakfast, and three capsules at night before dinner each day for three weeks.
|
|---|---|---|---|
|
Patient Assessment of Constipation - Symptoms (PAC-SYM)
Pre-treatment (CIC Group)
|
17.62 score on a scale
Standard Deviation 6.98
|
17.56 score on a scale
Standard Deviation 4.90
|
12.75 score on a scale
Standard Deviation 6.85
|
|
Patient Assessment of Constipation - Symptoms (PAC-SYM)
Post-treatment (CIC Group)
|
11.77 score on a scale
Standard Deviation 7.43
|
9.22 score on a scale
Standard Deviation 4.09
|
10.25 score on a scale
Standard Deviation 3.86
|
|
Patient Assessment of Constipation - Symptoms (PAC-SYM)
Post-treatment (IBS Group)
|
13.17 score on a scale
Standard Deviation 7.41
|
16.00 score on a scale
Standard Deviation 4.24
|
15.20 score on a scale
Standard Deviation 10.18
|
|
Patient Assessment of Constipation - Symptoms (PAC-SYM)
Pre-treatment (IBS Group)
|
18.67 score on a scale
Standard Deviation 11.08
|
17.00 score on a scale
Standard Deviation 4.24
|
17.40 score on a scale
Standard Deviation 7.30
|
SECONDARY outcome
Timeframe: Day -14 to Day 22Population: All participants who completed the study and had both pre and post treatment PAC-QOL ratings
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 time points. Data was specifically analyzed based on patient diagnosis in addition to treatment.
Outcome measures
| Measure |
CSP01
n=19 Participants
Subjects in the experimental group will receive CSP01, a non-systemic, orally administered hydrogel capsule, twice a day. CSP01 capsules are taken prior to a meal with water, after which the small particles within the capsules hydrate and expand in the stomach and small intestine. By acting as a bulking agent and possibly reducing colonic transit time through increase of colonic water content, CSP01 may contribute to constipation relief.
CSP01: Subjects will take three capsules in the morning before breakfast, and three capsules at night before dinner each day for three weeks.
|
Carboxymethylcellulose (CMC)
n=11 Participants
Subjects in the active control group will receive orally administered 3 capsules of carboxymethylcellulose (CMC) capsules twice a day.
Carboxymethylcellulose (CMC): Subjects will take three capsules in the morning before breakfast, and three capsules at night before dinner each day for three weeks.
|
Placebo
n=9 Participants
Matching placebo consists of an inert mixture supplied by Gelesis Inc. in identical-appearing capsules.Subjects in the placebo group will be administered 3 capsules of placebo twice a day.
Placebo: Subjects will take three capsules in the morning before breakfast, and three capsules at night before dinner each day for three weeks.
|
|---|---|---|---|
|
Patient Assessment of Constipation - Quality of Life (PAC-QOL)
Pre-treatment (CIC Group)
|
39.08 score on a scale
Standard Deviation 17.09
|
31.22 score on a scale
Standard Deviation 6.57
|
26.50 score on a scale
Standard Deviation 14.25
|
|
Patient Assessment of Constipation - Quality of Life (PAC-QOL)
Post-treatment (IBS Group)
|
30.33 score on a scale
Standard Deviation 20.20
|
23.00 score on a scale
Standard Deviation 1.41
|
35.60 score on a scale
Standard Deviation 8.53
|
|
Patient Assessment of Constipation - Quality of Life (PAC-QOL)
Post-treatment (CIC Group)
|
26.46 score on a scale
Standard Deviation 18.30
|
20.56 score on a scale
Standard Deviation 4.42
|
19.75 score on a scale
Standard Deviation 6.99
|
|
Patient Assessment of Constipation - Quality of Life (PAC-QOL)
Pre-treatment (IBS Group)
|
41.00 score on a scale
Standard Deviation 17.01
|
32.00 score on a scale
Standard Deviation 4.24
|
34.30 score on a scale
Standard Deviation 14.48
|
SECONDARY outcome
Timeframe: 55 days (baseline, treatment, & follow-up)Population: All participants who completed the study and had daily medication usage data
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)
Outcome measures
| Measure |
CSP01
n=19 Participants
Subjects in the experimental group will receive CSP01, a non-systemic, orally administered hydrogel capsule, twice a day. CSP01 capsules are taken prior to a meal with water, after which the small particles within the capsules hydrate and expand in the stomach and small intestine. By acting as a bulking agent and possibly reducing colonic transit time through increase of colonic water content, CSP01 may contribute to constipation relief.
CSP01: Subjects will take three capsules in the morning before breakfast, and three capsules at night before dinner each day for three weeks.
|
Carboxymethylcellulose (CMC)
n=11 Participants
Subjects in the active control group will receive orally administered 3 capsules of carboxymethylcellulose (CMC) capsules twice a day.
Carboxymethylcellulose (CMC): Subjects will take three capsules in the morning before breakfast, and three capsules at night before dinner each day for three weeks.
|
Placebo
n=9 Participants
Matching placebo consists of an inert mixture supplied by Gelesis Inc. in identical-appearing capsules.Subjects in the placebo group will be administered 3 capsules of placebo twice a day.
Placebo: Subjects will take three capsules in the morning before breakfast, and three capsules at night before dinner each day for three weeks.
|
|---|---|---|---|
|
Need for Rescue Laxatives
|
13 days
|
6 days
|
3 days
|
SECONDARY outcome
Timeframe: 55 days (baseline, treatment, & follow-up)Population: All participants who completed the study and had both pre and post treatment SBM measurements
Average number of Spontaneous Bowel Movements per day. (Spontaneous Bowel Movements include both complete and incomplete bowel movements)
Outcome measures
| Measure |
CSP01
n=19 Participants
Subjects in the experimental group will receive CSP01, a non-systemic, orally administered hydrogel capsule, twice a day. CSP01 capsules are taken prior to a meal with water, after which the small particles within the capsules hydrate and expand in the stomach and small intestine. By acting as a bulking agent and possibly reducing colonic transit time through increase of colonic water content, CSP01 may contribute to constipation relief.
CSP01: Subjects will take three capsules in the morning before breakfast, and three capsules at night before dinner each day for three weeks.
|
Carboxymethylcellulose (CMC)
n=11 Participants
Subjects in the active control group will receive orally administered 3 capsules of carboxymethylcellulose (CMC) capsules twice a day.
Carboxymethylcellulose (CMC): Subjects will take three capsules in the morning before breakfast, and three capsules at night before dinner each day for three weeks.
|
Placebo
n=9 Participants
Matching placebo consists of an inert mixture supplied by Gelesis Inc. in identical-appearing capsules.Subjects in the placebo group will be administered 3 capsules of placebo twice a day.
Placebo: Subjects will take three capsules in the morning before breakfast, and three capsules at night before dinner each day for three weeks.
|
|---|---|---|---|
|
Spontaneous Bowel Movement (SBM) Frequency
Pre-treatment
|
0.75 number of SBMs per day
Standard Deviation 0.29
|
0.70 number of SBMs per day
Standard Deviation 0.40
|
0.75 number of SBMs per day
Standard Deviation 0.39
|
|
Spontaneous Bowel Movement (SBM) Frequency
Post-treatment
|
0.95 number of SBMs per day
Standard Deviation 0.36
|
0.79 number of SBMs per day
Standard Deviation 0.35
|
0.89 number of SBMs per day
Standard Deviation 0.58
|
Adverse Events
CSP01
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Carboxymethylcellulose (CMC)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
CSP01
n=20 participants at risk
Subjects in the experimental group will receive CSP01, a non-systemic, orally administered hydrogel capsule, twice a day. CSP01 capsules are taken prior to a meal with water, after which the small particles within the capsules hydrate and expand in the stomach and small intestine. By acting as a bulking agent and possibly reducing colonic transit time through increase of colonic water content, CSP01 may contribute to constipation relief.
CSP01: Subjects will take three capsules in the morning before breakfast, and three capsules at night before dinner each day for three weeks.
|
Carboxymethylcellulose (CMC)
n=11 participants at risk
Subjects in the active control group will receive orally administered 3 capsules of carboxymethylcellulose (CMC) capsules twice a day.
Carboxymethylcellulose (CMC): Subjects will take three capsules in the morning before breakfast, and three capsules at night before dinner each day for three weeks.
|
Placebo
n=9 participants at risk
Matching placebo consists of an inert mixture supplied by Gelesis Inc. in identical-appearing capsules.Subjects in the placebo group will be administered 3 capsules of placebo twice a day.
Placebo: Subjects will take three capsules in the morning before breakfast, and three capsules at night before dinner each day for three weeks.
|
|---|---|---|---|
|
Gastrointestinal disorders
Constipation and back pain caused by constipation
|
5.0%
1/20 • Number of events 1 • 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.
All participants of the study were assessed for adverse events throughout the duration of the study. Adverse events were recorded, logged, and reported to the IRB where applicable. In-person follow-up was arranged for participants experiencing an adverse event to monitor resolution of symptoms.
|
0.00%
0/11 • 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.
All participants of the study were assessed for adverse events throughout the duration of the study. Adverse events were recorded, logged, and reported to the IRB where applicable. In-person follow-up was arranged for participants experiencing an adverse event to monitor resolution of symptoms.
|
0.00%
0/9 • 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.
All participants of the study were assessed for adverse events throughout the duration of the study. Adverse events were recorded, logged, and reported to the IRB where applicable. In-person follow-up was arranged for participants experiencing an adverse event to monitor resolution of symptoms.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place