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

NCT03054506 | Completed Results FDA Device

• 1 other identifier: 2016P001751
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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).

Conditions

Constipation; Chronic Idiopathic Constipation; Irritable Bowel Syndrome With Constipation

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 1 week; measured once during the run-in-period and again during third week of the treatment period

Secondary Outcomes (11)

• Complete Spontaneous Bowel Movement (CSBM) Frequency Rate

  55 days (baseline, treatment, & follow-up)

• Stool Consistency

  55 days (baseline, treatment, & follow-up)

• Ease of Passage Rating

  55 days (baseline, treatment, & follow-up)

• Patient's Assessment of Abdominal Discomfort

  55 days (baseline, treatment, & follow-up)

• Patient Assessment of Bloating Severity

  55 days (baseline, treatment, & follow-up)

Study Arms (3)

CSP01

EXPERIMENTAL

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.

Device: CSP01

Carboxymethylcellulose (CMC)

ACTIVE COMPARATOR

Subjects in the active control group will receive orally administered 3 capsules of carboxymethylcellulose (CMC) capsules twice a day.

Device: Carboxymethylcellulose (CMC)

Placebo

PLACEBO COMPARATOR

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.

Device: Placebo

Interventions

CSP01 DEVICE

Subjects will take three capsules in the morning before breakfast, and three capsules at night before dinner each day for three weeks.

CSP01

Carboxymethylcellulose (CMC) DEVICE

Subjects will take three capsules in the morning before breakfast, and three capsules at night before dinner each day for three weeks.

Carboxymethylcellulose (CMC)

Placebo DEVICE

Subjects will take three capsules in the morning before breakfast, and three capsules at night before dinner each day for three weeks.

Placebo

Eligibility Criteria

• Age: 22 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 22-70 years old
• BMI \>18.5 and \<35 kg/m2
• Rome III criteria for functional constipation or IBS-C
• Continued IBS-C or CIC throughout Run-in period
• 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).
• Ability to follow verbal and written instructions
• 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)
• Informed consent form signed by the subjects

You may not qualify if:

• History of loose stools
• History of irritable bowel syndrome with diarrhea (IBS-D) or mixed irritable bowel syndrome (IBS-M)
• Non-compliance with reporting during Run-in
• Patients reporting laxative, enema, and/or suppository usage for \>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 \<18.5 or \>35 kg/m2
• Pregnancy (or positive serum or urine pregnancy test(s) in females of childbearing potential) or lactation

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Gelesis, Inc.: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Target number of participants needed to achieve target power was not attained. One subject's post-treatment SmartPill data was irretrievable due to unexpected technical malfunction, therefore post-treatment colonic transit time was not collected.

Results Point of Contact

• Title: Dr. Kyle Staller
• Organization: Massachusetts General Hospital

kstaller@mgh.harvard.edu

617-726-3080

Study Officials

• Kyle Staller, MD, MPH

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Kyle Staller, MD, MPH

Study Record Dates

• First Submitted: February 7, 2017
• First Posted: February 15, 2017
• Study Start: March 7, 2017
• Primary Completion: May 10, 2018
• Study Completion: February 1, 2019
• Last Updated: August 20, 2019
• Results First Posted: August 20, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)