N/A
N=40
The Effect of CSP01 on Chronic Idiopathic Constipation and Irritable Bowel Syndrome With Constipation
Constipation · Chronic Idiopathic Constipation · Irritable Bowel Syndrome With Constipation
Bottom Line
View on ClinicalTrials.gov: NCT03054506 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Aug 2019
Primary outcome: Primary: Change From Baseline in Colonic Transit Time (CTT) — -727; -15; 366 minutes
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- CSP01 (Device); Carboxymethylcellulose (CMC) (Device); Placebo (Device)
- Age
- Adult, Older Adult · 22+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- May 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Colonic Transit Time (CTT) |
-727; -15; 366 | — |
| SECONDARY Complete Spontaneous Bowel Movement (CSBM) Frequency Rate |
0.2; 0.2; 0.2; 0.3; 0.3; 0.3 | — |
| SECONDARY Stool Consistency |
3.62; 3.54; 3.88; 3.81; 3.62; 3.59 | — |
| SECONDARY Ease of Passage Rating |
3.62; 3.54; 3.88; 3.81; 3.62; 3.59 | — |
| SECONDARY Patient's Assessment of Abdominal Discomfort |
3.91; 3.55; 3.82; 3.67; 3.08; 3.58 | — |
| SECONDARY Patient Assessment of Bloating Severity |
4.36; 4.43; 4.67; 4.17; 3.89; 3.98 | — |
| SECONDARY Patient Assessment of Constipation Severity |
4.11; 4.04; 4.15; 3.46; 3.29; 3.85 | — |
| SECONDARY Relief Rating |
4.27; 4.21; 4.11; 5.11; 4.86; 4.38 | — |
| SECONDARY Patient Assessment of Constipation - Symptoms (PAC-SYM) |
17.62; 17.56; 12.75; 11.77; 9.22; 10.25 | — |
| SECONDARY Patient Assessment of Constipation - Quality of Life (PAC-QOL) |
39.08; 31.22; 26.50; 26.46; 20.56; 19.75 | — |
| SECONDARY Need for Rescue Laxatives |
13; 6; 3 | — |
| SECONDARY Spontaneous Bowel Movement (SBM) Frequency |
0.75; 0.70; 0.75; 0.95; 0.79; 0.89 | — |
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).
Eligibility Criteria
Inclusion Criteria
- Age 22-70 years old
- BMI >18.5 and 2 days or any usage of a prohibited medication during the Run-in period
- 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
- GI motility obstruction or GI tract structural abnormality
- Current use of prescribed or illicit opioids
- History of pelvic floor dysfunction
- Need for manual maneuvers in order to achieve a BM
- History of GI lumen surgery at any time or other GI or abdominal operations within 60 days prior to entry into the study
- History of high-dose stimulative or cathartic laxative abuse as judged by investigator team
- Neurological disorders, metabolic disorders, or other significant disease that would impair their ability to participate in the study
- Cardiovascular disease, diabetes, cancer, Crohn's disease, ulcerative colitis
- BMI of 35 kg/m2
- Pregnancy (or positive serum or urine pregnancy test(s) in females of childbearing potential) or lactation
- Absence of contraception in females of childbearing potential
- History of allergic reaction to carboxymethylcellulose, citric acid, sodium stearyl fumarate, raw cane sugar, gelatin, or titanium dioxide
- Administration of investigational products within 1 month prior to Screening Visit
- Exclusion of colonic inertia with symptoms of 160 mm Hg and/or supine DBP > 95 mm Hg (mean of two consecutive readings)
- Angina, coronary bypass, or myocardial infarction within 6 months prior to Screening Visit
- History of swallowing disorders
- Esophageal anatomic abnormalities (e.g., webs, diverticuli, rings)
- History of gastric bypass or any other gastric surgery
- History of small bowel resection (except if related to appendectomy)
- History of gastric or duodenal ulcer
- History of gastroparesis
- History of abdominal radiation treatment
- History of pancreatitis
- History of intestinal stricture (e.g., Crohn's disease)
- History of intestinal obstruction or subjects at high risk of intestinal obstruction including suspected small bowel adhesions
- History of malabsorption
- History of sucrose intolerance
- History of hepatitis B or C
- History of human immunodeficiency virus
- History of cancer within the past 5 years (except adequately-treated localized basal cell skin cancer or in situ uterine cervical cancer)
- 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)
- HbA1c > 8.5% (> 69 mmol/mol)
- Positive test for drugs in the urine
- Any relevant biochemical abnormality interfering with the assessments of Gelesis100, according to the Investigator
- 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)
- Medications requiring mandatory administration with meal at lunch or dinner
- Anticipated requirement for use of prohibited concomitant medications
- Implanted or externally worn medical device such as, but not limited to, a pacemaker, infusion pump, or insulin pump
Data sourced from ClinicalTrials.gov (NCT03054506). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.