Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03054506
Recruitment Status : Completed
First Posted : February 15, 2017
Results First Posted : August 20, 2019
Last Update Posted : August 20, 2019
Sponsor:
Collaborator:
Gelesis, Inc.
Information provided by (Responsible Party):
Kyle Staller, MD, MPH, Massachusetts General Hospital

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).

Condition or disease Intervention/treatment Phase
Constipation Chronic Idiopathic Constipation Irritable Bowel Syndrome With Constipation Device: CSP01 Device: Carboxymethylcellulose (CMC) Device: Placebo Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : March 7, 2017
Actual Primary Completion Date : May 10, 2018
Actual Study Completion Date : February 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation

Arm Intervention/treatment
Experimental: 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.
Device: CSP01
Subjects will take three capsules in the morning before breakfast, and three capsules at night before dinner each day for three weeks.

Active Comparator: Carboxymethylcellulose (CMC)
Subjects in the active control group will receive orally administered 3 capsules of carboxymethylcellulose (CMC) capsules twice a day.
Device: 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 Comparator: 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.
Device: Placebo
Subjects will take three capsules in the morning before breakfast, and three capsules at night before dinner each day for three weeks.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Complete Spontaneous Bowel Movement (CSBM) Frequency Rate [ Time Frame: 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.

  2. Stool Consistency [ Time Frame: 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


  3. Ease of Passage Rating [ Time Frame: 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

  4. Patient's Assessment of Abdominal Discomfort [ Time Frame: 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.

  5. Patient Assessment of Bloating Severity [ Time Frame: 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.

  6. Patient Assessment of Constipation Severity [ Time Frame: 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.

  7. Relief Rating [ Time Frame: 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).

  8. Patient Assessment of Constipation - Symptoms (PAC-SYM) [ Time Frame: 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.


  9. Patient Assessment of Constipation - Quality of Life (PAC-QOL) [ Time Frame: 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.


  10. Need for Rescue Laxatives [ Time Frame: 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)


  11. Spontaneous Bowel Movement (SBM) Frequency [ Time Frame: 55 days (baseline, treatment, & follow-up) ]
    Average number of Spontaneous Bowel Movements per day. (Spontaneous Bowel Movements include both complete and incomplete bowel movements)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   22 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03054506


Locations
Layout table for location information
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Gelesis, Inc.
Investigators
Layout table for investigator information
Principal Investigator: Kyle Staller, MD, MPH Massachusetts General Hospital
  Study Documents (Full-Text)

Documents provided by Kyle Staller, MD, MPH, Massachusetts General Hospital:
Informed Consent Form  [PDF] October 25, 2017

Layout table for additonal information
Responsible Party: Kyle Staller, MD, MPH, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03054506    
Other Study ID Numbers: 2016P001751
First Posted: February 15, 2017    Key Record Dates
Results First Posted: August 20, 2019
Last Update Posted: August 20, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
Layout table for MeSH terms
Irritable Bowel Syndrome
Syndrome
Constipation
Disease
Pathologic Processes
Signs and Symptoms, Digestive
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Carboxymethylcellulose Sodium
Laxatives
Gastrointestinal Agents