A Randomized, Single Center, Double-blind, Parallel-group, Placebo-controlled Study Assessing the Effect of CSP01 on Chronic Idiopathic Constipation and Irritable Bowel Syndrome With Constipation

Massachusetts General Hospital1 site in 1 country52 target enrollmentMarch 7, 2017

ConditionsConstipation Chronic Idiopathic Constipation Irritable Bowel Syndrome With Constipation

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Constipation
Sponsor: Massachusetts General Hospital
Enrollment: 52
Locations: 1
Primary Endpoint: Change From Baseline in Colonic Transit Time (CTT)
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

March 7, 2017

End Date

February 1, 2019

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Massachusetts General Hospital

Responsible Party

Principal Investigator

Kyle Staller, MD, MPH

Massachusetts General Hospital

Eligibility Criteria

Inclusion Criteria

•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

Exclusion Criteria

•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

Outcomes

Primary Outcomes

Change From Baseline in Colonic Transit Time (CTT)

Time Frame: 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 Outcomes

Stool Consistency(55 days (baseline, treatment, & follow-up))
Patient Assessment of Constipation Severity(55 days (baseline, treatment, & follow-up))
Relief Rating(55 days (baseline, treatment, & follow-up))
Complete Spontaneous Bowel Movement (CSBM) Frequency Rate(55 days (baseline, treatment, & follow-up))
Patient's Assessment of Abdominal Discomfort(55 days (baseline, treatment, & follow-up))
Patient Assessment of Constipation - Quality of Life (PAC-QOL)(Day -14 to Day 22)
Ease of Passage Rating(55 days (baseline, treatment, & follow-up))
Patient Assessment of Bloating Severity(55 days (baseline, treatment, & follow-up))
Patient Assessment of Constipation - Symptoms (PAC-SYM)(Day -14 to Day 22)
Need for Rescue Laxatives(55 days (baseline, treatment, & follow-up))
Spontaneous Bowel Movement (SBM) Frequency(55 days (baseline, treatment, & follow-up))