Chronic Idiopathic Constipation, Constipation, Irritable Bowel Syndrome With Constipation
Conditions
Brief summary
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).
Interventions
DEVICECSP01
Subjects will take three capsules in the morning before breakfast, and three capsules at night before dinner each day for three weeks.
DEVICECarboxymethylcellulose (CMC)
Subjects will take three capsules in the morning before breakfast, and three capsules at night before dinner each day for three weeks.
DEVICEPlacebo
Subjects will take three capsules in the morning before breakfast, and three capsules at night before dinner each day for three weeks.
Sponsors
Gelesis, Inc.
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
22 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Age 22-70 years old 2. BMI \>18.5 and \<35 kg/m2 3. Rome III criteria for functional constipation or IBS-C 4. Continued IBS-C or CIC throughout Run-in period 5. Compliant with reporting during Run-in (confirm the presence of constipation during the 7-day Run-in baseline period; patients are required to report an average of \<3 continuous spontaneous bowel movements \[CSBMs\] and ≤6 spontaneous bowel movements \[SBMs\] per week via the interactive web response system). 6. Ability to follow verbal and written instructions 7. Ability to record daily bowel habits, including frequency, stool consistency (BSFS), straining (EoPS), completeness of evacuation, and Patient Reported Outcomes (PROs) (abdominal discomfort, severity of constipation, bloating, overall relief) 8. Informed consent form signed by the subjects
Exclusion criteria
1. History of loose stools 2. History of irritable bowel syndrome with diarrhea (IBS-D) or mixed irritable bowel syndrome (IBS-M) 3. Non-compliance with reporting during Run-in 4. Patients reporting laxative, enema, and/or suppository usage for \>2 days or any usage of a prohibited medication during the Run-in period 5. Patients reporting watery stools for any SBM (Type 7 on the Bristol Stool Form Scale \[BSFS\]) or loose (mushy) stools for \>1 SBM (Type 6 on the BSFS) in the absence of laxatives during Run-in 6. GI motility obstruction or GI tract structural abnormality 7. Current use of prescribed or illicit opioids 8. History of pelvic floor dysfunction 9. Need for manual maneuvers in order to achieve a BM 10. History of GI lumen surgery at any time or other GI or abdominal operations within 60 days prior to entry into the study 11. History of high-dose stimulative or cathartic laxative abuse as judged by investigator team 12. Neurological disorders, metabolic disorders, or other significant disease that would impair their ability to participate in the study 13. Cardiovascular disease, diabetes, cancer, Crohn's disease, ulcerative colitis 14. BMI of \<18.5 or \>35 kg/m2 15. Pregnancy (or positive serum or urine pregnancy test(s) in females of childbearing potential) or lactation 16. Absence of contraception in females of childbearing potential 17. History of allergic reaction to carboxymethylcellulose, citric acid, sodium stearyl fumarate, raw cane sugar, gelatin, or titanium dioxide 18. Administration of investigational products within 1 month prior to Screening Visit 19. Exclusion of colonic inertia with symptoms of \< 1 BM per 2 weeks 20. Subjects anticipating surgical intervention during the study 21. Known history of diabetes (type 1 or 2) 22. History of eating disorders including binge eating (except mild binge eater) 23. Supine SBP \> 160 mm Hg and/or supine DBP \> 95 mm Hg (mean of two consecutive readings) 24. Angina, coronary bypass, or myocardial infarction within 6 months prior to Screening Visit 25. History of swallowing disorders 26. Esophageal anatomic abnormalities (e.g., webs, diverticuli, rings) 27. History of gastric bypass or any other gastric surgery 28. History of small bowel resection (except if related to appendectomy) 29. History of gastric or duodenal ulcer 30. History of gastroparesis 31. History of abdominal radiation treatment 32. History of pancreatitis 33. History of intestinal stricture (e.g., Crohn's disease) 34. History of intestinal obstruction or subjects at high risk of intestinal obstruction including suspected small bowel adhesions 35. History of malabsorption 36. History of sucrose intolerance 37. History of hepatitis B or C 38. History of human immunodeficiency virus 39. History of cancer within the past 5 years (except adequately-treated localized basal cell skin cancer or in situ uterine cervical cancer) 40. Any other clinically significant disease interfering with the assessments of Gelesis100, according to the Investigator (e.g., disease requiring corrective treatment, potentially leading to study discontinuation) 41. HbA1c \> 8.5% (\> 69 mmol/mol) 42. Positive test for drugs in the urine 43. Any relevant biochemical abnormality interfering with the assessments of Gelesis100, according to the Investigator 44. Antidiabetic medications within 1 month prior to Screening Visit (except stable dose of metformin, ≤ 1500 mg/day, for at least 1 month in subjects with type 2 diabetes) 45. Medications requiring mandatory administration with meal at lunch or dinner 46. Anticipated requirement for use of prohibited concomitant medications 47. Implanted or externally worn medical device such as, but not limited to, a pacemaker, infusion pump, or insulin pump
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Colonic Transit Time (CTT) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complete Spontaneous Bowel Movement (CSBM) Frequency Rate | 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. |
| Stool Consistency | 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 |
| Ease of Passage Rating | 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 |
| Patient's Assessment of Abdominal Discomfort | 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. |
| Patient Assessment of Constipation Severity | 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. |
| Patient Assessment of Bloating Severity | 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. |
| Patient Assessment of Constipation - Symptoms (PAC-SYM) | 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 diagnosis in addition to treatment. |
| Patient Assessment of Constipation - Quality of Life (PAC-QOL) | 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 time points. Data was specifically analyzed based on patient diagnosis in addition to treatment. |
| Need for Rescue Laxatives | 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) |
| Spontaneous Bowel Movement (SBM) Frequency | 55 days (baseline, treatment, & follow-up) | Average number of Spontaneous Bowel Movements per day. (Spontaneous Bowel Movements include both complete and incomplete bowel movements) |
| Relief Rating | 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). |
Countries
United States
Participant flow
Pre-assignment details
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
Participants by arm
| Arm | Count |
|---|---|
| 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. | 20 |
| 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. | 11 |
| 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. | 9 |
| Total | 40 |
Baseline characteristics
| Characteristic | CSP01 | Carboxymethylcellulose (CMC) | Placebo | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 5 Participants | 2 Participants | 1 Participants | 8 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants | 9 Participants | 8 Participants | 32 Participants |
| Diagnosis: CIC, IBS-C Chronic Idiopathic Constipation | 14 Participants | 9 Participants | 4 Participants | 27 Participants |
| Diagnosis: CIC, IBS-C Irritable Bowel Syndrome with Constipation | 6 Participants | 2 Participants | 5 Participants | 13 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 2 Participants | 0 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 20 Participants | 9 Participants | 9 Participants | 38 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 1 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 16 Participants | 8 Participants | 8 Participants | 32 Participants |
| Region of Enrollment United States | 20 participants | 11 participants | 9 participants | 40 participants |
| Sex: Female, Male Female | 19 Participants | 9 Participants | 7 Participants | 35 Participants |
| Sex: Female, Male Male | 1 Participants | 2 Participants | 2 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 11 | 0 / 9 |
| other Total, other adverse events | 1 / 20 | 0 / 11 | 0 / 9 |
| serious Total, serious adverse events | 0 / 20 | 0 / 11 | 0 / 9 |
Outcome results
Primary
Change From Baseline in Colonic Transit Time (CTT)
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.
Time frame: Up to 1 week; measured once during the run-in-period and again during third week of the treatment period
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CSP01 | Change From Baseline in Colonic Transit Time (CTT) | -727 minutes | Standard Deviation 1277 |
| Carboxymethylcellulose (CMC) | Change From Baseline in Colonic Transit Time (CTT) | -15 minutes | Standard Deviation 2226 |
| Placebo | Change From Baseline in Colonic Transit Time (CTT) | 366 minutes | Standard Deviation 1714 |
Secondary
Complete Spontaneous Bowel Movement (CSBM) Frequency Rate
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.
Time frame: 55 days (baseline, treatment, & follow-up)
Population: All participants who completed the study and had both pre and post treatment CSBM measurement
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CSP01 | Complete Spontaneous Bowel Movement (CSBM) Frequency Rate | Pre-treatment | 0.2 number of CSBMs per day | Standard Deviation 0.2 |
| CSP01 | Complete Spontaneous Bowel Movement (CSBM) Frequency Rate | Post-treatment | 0.3 number of CSBMs per day | Standard Deviation 0.3 |
| Carboxymethylcellulose (CMC) | Complete Spontaneous Bowel Movement (CSBM) Frequency Rate | Pre-treatment | 0.2 number of CSBMs per day | Standard Deviation 0.2 |
| Carboxymethylcellulose (CMC) | Complete Spontaneous Bowel Movement (CSBM) Frequency Rate | Post-treatment | 0.3 number of CSBMs per day | Standard Deviation 0.2 |
| Placebo | Complete Spontaneous Bowel Movement (CSBM) Frequency Rate | Pre-treatment | 0.2 number of CSBMs per day | Standard Deviation 0.3 |
| Placebo | Complete Spontaneous Bowel Movement (CSBM) Frequency Rate | Post-treatment | 0.3 number of CSBMs per day | Standard Deviation 0.3 |
Secondary
Ease of Passage Rating
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
Time frame: 55 days (baseline, treatment, & follow-up)
Population: All participants who completed the study and had both pre and post treatment ease of passage ratings
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CSP01 | Ease of Passage Rating | Pre-treatment | 3.62 score on a scale | Standard Deviation 0.56 |
| CSP01 | Ease of Passage Rating | Post-treatment | 3.81 score on a scale | Standard Deviation 0.44 |
| Carboxymethylcellulose (CMC) | Ease of Passage Rating | Pre-treatment | 3.54 score on a scale | Standard Deviation 0.45 |
| Carboxymethylcellulose (CMC) | Ease of Passage Rating | Post-treatment | 3.62 score on a scale | Standard Deviation 0.59 |
| Placebo | Ease of Passage Rating | Pre-treatment | 3.88 score on a scale | Standard Deviation 0.65 |
| Placebo | Ease of Passage Rating | Post-treatment | 3.59 score on a scale | Standard Deviation 0.63 |
Secondary
Need for Rescue Laxatives
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)
Time frame: 55 days (baseline, treatment, & follow-up)
Population: All participants who completed the study and had daily medication usage data
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CSP01 | Need for Rescue Laxatives | 13 days |
| Carboxymethylcellulose (CMC) | Need for Rescue Laxatives | 6 days |
| Placebo | Need for Rescue Laxatives | 3 days |
Secondary
Patient Assessment of Bloating Severity
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.
Time frame: 55 days (baseline, treatment, & follow-up)
Population: All participants who completed the study and had both pre and post treatment bloating ratings.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CSP01 | Patient Assessment of Bloating Severity | Pre-treatment | 4.36 score on a scale | Standard Deviation 2.2 |
| CSP01 | Patient Assessment of Bloating Severity | Post-treatment | 4.17 score on a scale | Standard Deviation 2.22 |
| Carboxymethylcellulose (CMC) | Patient Assessment of Bloating Severity | Pre-treatment | 4.43 score on a scale | Standard Deviation 1.42 |
| Carboxymethylcellulose (CMC) | Patient Assessment of Bloating Severity | Post-treatment | 3.89 score on a scale | Standard Deviation 1.16 |
| Placebo | Patient Assessment of Bloating Severity | Pre-treatment | 4.67 score on a scale | Standard Deviation 2.47 |
| Placebo | Patient Assessment of Bloating Severity | Post-treatment | 3.98 score on a scale | Standard Deviation 2.8 |
Secondary
Patient Assessment of Constipation - Quality of Life (PAC-QOL)
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.
Time frame: Day -14 to Day 22
Population: All participants who completed the study and had both pre and post treatment PAC-QOL ratings
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CSP01 | Patient Assessment of Constipation - Quality of Life (PAC-QOL) | Post-treatment (CIC Group) | 26.46 score on a scale | Standard Deviation 18.3 |
| CSP01 | Patient Assessment of Constipation - Quality of Life (PAC-QOL) | Pre-treatment (CIC Group) | 39.08 score on a scale | Standard Deviation 17.09 |
| CSP01 | Patient Assessment of Constipation - Quality of Life (PAC-QOL) | Pre-treatment (IBS Group) | 41.00 score on a scale | Standard Deviation 17.01 |
| CSP01 | Patient Assessment of Constipation - Quality of Life (PAC-QOL) | Post-treatment (IBS Group) | 30.33 score on a scale | Standard Deviation 20.2 |
| Carboxymethylcellulose (CMC) | Patient Assessment of Constipation - Quality of Life (PAC-QOL) | Post-treatment (IBS Group) | 23.00 score on a scale | Standard Deviation 1.41 |
| Carboxymethylcellulose (CMC) | Patient Assessment of Constipation - Quality of Life (PAC-QOL) | Pre-treatment (IBS Group) | 32.00 score on a scale | Standard Deviation 4.24 |
| Carboxymethylcellulose (CMC) | Patient Assessment of Constipation - Quality of Life (PAC-QOL) | Pre-treatment (CIC Group) | 31.22 score on a scale | Standard Deviation 6.57 |
| Carboxymethylcellulose (CMC) | Patient Assessment of Constipation - Quality of Life (PAC-QOL) | Post-treatment (CIC Group) | 20.56 score on a scale | Standard Deviation 4.42 |
| Placebo | Patient Assessment of Constipation - Quality of Life (PAC-QOL) | Pre-treatment (CIC Group) | 26.50 score on a scale | Standard Deviation 14.25 |
| Placebo | Patient Assessment of Constipation - Quality of Life (PAC-QOL) | Post-treatment (CIC Group) | 19.75 score on a scale | Standard Deviation 6.99 |
| Placebo | Patient Assessment of Constipation - Quality of Life (PAC-QOL) | Pre-treatment (IBS Group) | 34.30 score on a scale | Standard Deviation 14.48 |
| Placebo | Patient Assessment of Constipation - Quality of Life (PAC-QOL) | Post-treatment (IBS Group) | 35.60 score on a scale | Standard Deviation 8.53 |
Secondary
Patient Assessment of Constipation Severity
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.
Time frame: 55 days (baseline, treatment, & follow-up)
Population: All participants who completed the study and had both pre and post treatment constipation severity ratings
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CSP01 | Patient Assessment of Constipation Severity | Pre-treatment | 4.11 score on a scale | Standard Deviation 2.06 |
| CSP01 | Patient Assessment of Constipation Severity | Post-treatment | 3.46 score on a scale | Standard Deviation 1.77 |
| Carboxymethylcellulose (CMC) | Patient Assessment of Constipation Severity | Pre-treatment | 4.04 score on a scale | Standard Deviation 1.34 |
| Carboxymethylcellulose (CMC) | Patient Assessment of Constipation Severity | Post-treatment | 3.29 score on a scale | Standard Deviation 1.15 |
| Placebo | Patient Assessment of Constipation Severity | Pre-treatment | 4.15 score on a scale | Standard Deviation 2.53 |
| Placebo | Patient Assessment of Constipation Severity | Post-treatment | 3.85 score on a scale | Standard Deviation 2.5 |
Secondary
Patient Assessment of Constipation - Symptoms (PAC-SYM)
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.
Time frame: Day -14 to Day 22
Population: All participants who completed the study and had both pre and post treatment PAC-SYM ratings
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CSP01 | Patient Assessment of Constipation - Symptoms (PAC-SYM) | Pre-treatment (IBS Group) | 18.67 score on a scale | Standard Deviation 11.08 |
| CSP01 | Patient Assessment of Constipation - Symptoms (PAC-SYM) | Post-treatment (CIC Group) | 11.77 score on a scale | Standard Deviation 7.43 |
| CSP01 | Patient Assessment of Constipation - Symptoms (PAC-SYM) | Pre-treatment (CIC Group) | 17.62 score on a scale | Standard Deviation 6.98 |
| CSP01 | Patient Assessment of Constipation - Symptoms (PAC-SYM) | Post-treatment (IBS Group) | 13.17 score on a scale | Standard Deviation 7.41 |
| Carboxymethylcellulose (CMC) | Patient Assessment of Constipation - Symptoms (PAC-SYM) | Post-treatment (CIC Group) | 9.22 score on a scale | Standard Deviation 4.09 |
| Carboxymethylcellulose (CMC) | Patient Assessment of Constipation - Symptoms (PAC-SYM) | Pre-treatment (CIC Group) | 17.56 score on a scale | Standard Deviation 4.9 |
| Carboxymethylcellulose (CMC) | Patient Assessment of Constipation - Symptoms (PAC-SYM) | Pre-treatment (IBS Group) | 17.00 score on a scale | Standard Deviation 4.24 |
| Carboxymethylcellulose (CMC) | Patient Assessment of Constipation - Symptoms (PAC-SYM) | Post-treatment (IBS Group) | 16.00 score on a scale | Standard Deviation 4.24 |
| Placebo | Patient Assessment of Constipation - Symptoms (PAC-SYM) | Pre-treatment (IBS Group) | 17.40 score on a scale | Standard Deviation 7.3 |
| Placebo | Patient Assessment of Constipation - Symptoms (PAC-SYM) | Post-treatment (CIC Group) | 10.25 score on a scale | Standard Deviation 3.86 |
| Placebo | Patient Assessment of Constipation - Symptoms (PAC-SYM) | Pre-treatment (CIC Group) | 12.75 score on a scale | Standard Deviation 6.85 |
| Placebo | Patient Assessment of Constipation - Symptoms (PAC-SYM) | Post-treatment (IBS Group) | 15.20 score on a scale | Standard Deviation 10.18 |
Secondary
Patient's Assessment of Abdominal Discomfort
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.
Time frame: 55 days (baseline, treatment, & follow-up)
Population: All participants who completed the study and had both pre and post treatment abdominal discomfort ratings
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CSP01 | Patient's Assessment of Abdominal Discomfort | Pre-treatment | 3.91 score on a scale | Standard Deviation 1.75 |
| CSP01 | Patient's Assessment of Abdominal Discomfort | Post-treatment | 3.67 score on a scale | Standard Deviation 1.91 |
| Carboxymethylcellulose (CMC) | Patient's Assessment of Abdominal Discomfort | Pre-treatment | 3.55 score on a scale | Standard Deviation 1.43 |
| Carboxymethylcellulose (CMC) | Patient's Assessment of Abdominal Discomfort | Post-treatment | 3.08 score on a scale | Standard Deviation 1.41 |
| Placebo | Patient's Assessment of Abdominal Discomfort | Pre-treatment | 3.82 score on a scale | Standard Deviation 2.23 |
| Placebo | Patient's Assessment of Abdominal Discomfort | Post-treatment | 3.58 score on a scale | Standard Deviation 2.6 |
Secondary
Relief Rating
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).
Time frame: 55 days (baseline, treatment, & follow-up)
Population: All participants who completed the study and had both pre and post treatment relief ratings
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CSP01 | Relief Rating | Pre-treatment | 4.27 score on a scale | Standard Deviation 1.95 |
| CSP01 | Relief Rating | Post-treatment | 5.11 score on a scale | Standard Deviation 2.29 |
| Carboxymethylcellulose (CMC) | Relief Rating | Pre-treatment | 4.21 score on a scale | Standard Deviation 1.91 |
| Carboxymethylcellulose (CMC) | Relief Rating | Post-treatment | 4.86 score on a scale | Standard Deviation 1.99 |
| Placebo | Relief Rating | Pre-treatment | 4.11 score on a scale | Standard Deviation 1.78 |
| Placebo | Relief Rating | Post-treatment | 4.38 score on a scale | Standard Deviation 1.79 |
Secondary
Spontaneous Bowel Movement (SBM) Frequency
Average number of Spontaneous Bowel Movements per day. (Spontaneous Bowel Movements include both complete and incomplete bowel movements)
Time frame: 55 days (baseline, treatment, & follow-up)
Population: All participants who completed the study and had both pre and post treatment SBM measurements
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CSP01 | Spontaneous Bowel Movement (SBM) Frequency | Pre-treatment | 0.75 number of SBMs per day | Standard Deviation 0.29 |
| CSP01 | Spontaneous Bowel Movement (SBM) Frequency | Post-treatment | 0.95 number of SBMs per day | Standard Deviation 0.36 |
| Carboxymethylcellulose (CMC) | Spontaneous Bowel Movement (SBM) Frequency | Pre-treatment | 0.70 number of SBMs per day | Standard Deviation 0.4 |
| Carboxymethylcellulose (CMC) | Spontaneous Bowel Movement (SBM) Frequency | Post-treatment | 0.79 number of SBMs per day | Standard Deviation 0.35 |
| Placebo | Spontaneous Bowel Movement (SBM) Frequency | Post-treatment | 0.89 number of SBMs per day | Standard Deviation 0.58 |
| Placebo | Spontaneous Bowel Movement (SBM) Frequency | Pre-treatment | 0.75 number of SBMs per day | Standard Deviation 0.39 |
Secondary
Stool Consistency
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
Time frame: 55 days (baseline, treatment, & follow-up)
Population: All participants who completed the study and had both pre and post treatment stool consistency ratings.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CSP01 | Stool Consistency | Pre-treatment | 3.62 score on a scale | Standard Deviation 0.56 |
| CSP01 | Stool Consistency | Post-treatment | 3.81 score on a scale | Standard Deviation 0.44 |
| Carboxymethylcellulose (CMC) | Stool Consistency | Post-treatment | 3.62 score on a scale | Standard Deviation 0.59 |
| Carboxymethylcellulose (CMC) | Stool Consistency | Pre-treatment | 3.54 score on a scale | Standard Deviation 0.45 |
| Placebo | Stool Consistency | Post-treatment | 3.59 score on a scale | Standard Deviation 0.63 |
| Placebo | Stool Consistency | Pre-treatment | 3.88 score on a scale | Standard Deviation 0.65 |