A Safety and Efficacy Evaluation of BLI801 Laxative in Adults Experiencing Non-Idiopathic Constipation

The objective of this study is to evaluate multiple doses of BLI801 Laxative for safety and efficacy versus placebo in adults experiencing non-idiopathic constipation.

Study Overview

• Status: Completed
• Conditions: Constipation
• Intervention / Treatment: Drug: BLI801 Laxative; Drug: BLI801 Placebo

• Study Type: Interventional
• Enrollment (Actual): 434
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35209
      • Braintree Research Site 43
  • Arizona
    • Peoria, Arizona, United States, 85381
      • Braintree Research Site 30
    • Phoenix, Arizona, United States, 85018
      • Braintree Research Site 40
    • Phoenix, Arizona, United States, 85020
      • Braintree Research Site 52
    • Phoenix, Arizona, United States, 85029
      • Braintree Research Site 26
  • Arkansas
    • Fayetteville, Arkansas, United States, 72703
      • Braintree Research Site 56
    • Little Rock, Arkansas, United States, 72211
      • Braintree Research Site 4
  • California
    • Anaheim, California, United States, 92801
      • Braintree Research Site 51
    • Fountain Valley, California, United States, 92708
      • Braintree Research Site 54
    • Fresno, California, United States, 93710
      • Braintree Research Site 8
    • Long Beach, California, United States, 90806
      • Braintree Research Site 71
    • Oceanside, California, United States, 92056
      • Braintree Research Site 74
    • Sacramento, California, United States, 95821
      • Braintree Research Site 59
    • Sacramento, California, United States, 95842
      • Braintree Research Site 28
  • Florida
    • Brooksville, Florida, United States, 34601
      • Braintree Research Site 68
    • Fort Myers, Florida, United States, 33912
      • Braintree Research Site 36
    • Homestead, Florida, United States, 33030
      • Braintree Research Site 22
    • Jacksonville, Florida, United States, 32218
      • Braintree Research Site 5
    • Jacksonville, Florida, United States, 32257
      • Braintree Research Site 23
    • Miami, Florida, United States, 33186
      • Braintree Research Site 63
    • Orlando, Florida, United States, 32801
      • Braintree Research Site 29
    • Orlando, Florida, United States, 32806
      • Braintree Research Site 65
    • Ormond Beach, Florida, United States, 32174
      • Braintree Research Site 13
    • Saint Petersburg, Florida, United States, 33709
      • Braintree Research Site 20
    • Saint Petersburg, Florida, United States, 33709
      • Braintree Research Site 39
    • Tampa, Florida, United States, 33634
      • Braintree Research Site 31
    • West Palm Beach, Florida, United States, 33409
      • Braintree Research Site 41
  • Georgia
    • Blue Ridge, Georgia, United States, 30513
      • Braintree Research Site 57
  • Idaho
    • Boise, Idaho, United States, 83713
      • Braintree Research Site 48
  • Indiana
    • Evansville, Indiana, United States, 47714
      • Braintree Research Site 50
    • Lafayette, Indiana, United States, 47905
      • Braintree Research Site 55
  • Kansas
    • Wichita, Kansas, United States, 67203
      • Braintree Research Site 38
  • Kentucky
    • Edgewood, Kentucky, United States, 41017
      • Braintree Research Site 64
  • Louisiana
    • Lake Charles, Louisiana, United States, 70601
      • Braintree Research Site 73
  • Missouri
    • Saint Louis, Missouri, United States, 63042
      • Braintree Research Site 49
  • Nebraska
    • Omaha, Nebraska, United States, 68114
      • Braintree Research Site 19
    • Omaha, Nebraska, United States, 68134
      • Braintree Research Site 21
  • Nevada
    • Henderson, Nevada, United States, 89014
      • Braintree Research Site 69
    • Las Vegas, Nevada, United States, 89119
      • Braintree Research Site 1
    • Las Vegas, Nevada, United States, 89119
      • Braintree Research Site 44
    • Las Vegas, Nevada, United States, 89123
      • Braintree Research Site 34
  • New Jersey
    • Belvidere, New Jersey, United States, 07823
      • Braintree Research Site 7
    • Trenton, New Jersey, United States, 08611
      • Braintree Research Site 53
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • Braintree Research Site 10
  • New York
    • Brooklyn, New York, United States, 11235
      • Braintree Research Site 27
    • Great Neck, New York, United States, 11023
      • Braintree Research Site 25
    • Williamsville, New York, United States, 14221
      • Braintree Research Site 61
  • North Carolina
    • Greensboro, North Carolina, United States, 27410
      • Braintree Research Site 45
    • Winston-Salem, North Carolina, United States, 27103
      • Braintree Research Site 47
  • Ohio
    • Beavercreek, Ohio, United States, 45432
      • Braintree Research Site 2
    • Cincinnati, Ohio, United States, 45215
      • Braintree Research Site 76
    • Columbus, Ohio, United States, 43213
      • Braintree Research Site 3
    • Columbus, Ohio, United States, 43214
      • Braintree Research Site 60
    • Huber Heights, Ohio, United States, 45424
      • Braintree Research Site 14
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73109
      • Braintree Research Site 46
    • Oklahoma City, Oklahoma, United States, 73119
      • Braintree Research Site 16
  • Pennsylvania
    • Lansdale, Pennsylvania, United States, 19446
      • Braintree Research Site 18
  • South Carolina
    • Charleston, South Carolina, United States, 29406
      • Braintree Research Site 75
    • Greer, South Carolina, United States, 29651
      • Braintree Research Site 17
    • Myrtle Beach, South Carolina, United States, 29588
      • Braintree Research Site 42
    • Spartanburg, South Carolina, United States, 29303
      • Braintree Research Site 24
    • Spartanburg, South Carolina, United States, 29307
      • Braintree Research Site 72
    • Summerville, South Carolina, United States, 29485
      • Braintree Research Site 9
  • Tennessee
    • Chattanooga, Tennessee, United States, 37421
      • Braintree Research Site 37
    • Tullahoma, Tennessee, United States, 37388
      • Braintree Research Site 67
  • Texas
    • Austin, Texas, United States, 78705
      • Braintree Research Site 11
    • Carrollton, Texas, United States, 75007
      • Braintree Research Site 33
    • Channelview, Texas, United States, 77530
      • Braintree Research Site 62
    • Houston, Texas, United States, 77058
      • Braintree Research Site 70
  • Utah
    • Saint George, Utah, United States, 84790
      • Braintree Research Site 12
    • Salt Lake City, Utah, United States, 84107
      • Braintree Research Site 35
    • West Jordan, Utah, United States, 84088
      • Braintree Research Site 66
  • Washington
    • Tacoma, Washington, United States, 98405
      • Braintree Research Site 6

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 84 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Male or female subjects between the ages of > 18 and < 85 years

2. Constipated, defined by the following criteria: Fewer than 3 spontaneous defecations per week and at least one of the following symptoms for the previous 4 weeks:

   • Straining during > 25% of defecations
   • Lumpy or hard stools in > 25% of defecations
   • Sensation of incomplete evacuation for > 25% of defecations
3. Receiving a stable maintenance opioid regimen.
4. If female, and of child-bearing potential, is using an acceptable form of birth control
5. Negative pregnancy test at screening (Visit 1), if applicable
6. In the Investigator's judgment, subject is mentally competent to provide informed consent to participate in the study

Exclusion Criteria:

1. Subjects with known or suspected ileus, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis or toxic megacolon
2. Subjects who have had major surgery within 30 days before Visit 1; appendectomy or cholecystectomy 60 days before Visit 1; abdominal, pelvic, or retroperitoneal surgery 6 months before Visit 1; bariatric surgery or surgery to remove a segment of the GI tract at any time before Visit 1

3. Medical conditions associated with diarrhea, intermittent loose stools or constipation, which could confound the interpretation of the results, eg, fecal incontinence or irritable bowel syndrome. Subjects with irritable bowel syndrome (IBS) that has been previously diagnosed by a physician prior to initiation of the constipating therapy and that meets the following criteria, are excluded:

   1. Absence of a structural or biochemical explanation for the abdominal pain symptom
   2. At least 12 weeks during a period of 12 months, of abdominal discomfort or pain with at least 2 of the following 3 features:

   i. Relieved with defecation, and/or ii. Onset associated with a change in frequency of stool, and/or iii. Onset associated with a change in form of stool.

4. Subjects diagnosed with chronic constipation prior to initiation of opioid treatment
5. Subjects taking laxatives (with the exception of fiber supplements), prokinetic agents or antidiarrheal drugs and refuse to discontinue these treatments from Visit 1 until after completion of Visit 5
6. Subjects who are pregnant or nursing, or intend to become pregnant during the study
7. Subjects of childbearing potential who refuse a pregnancy test
8. Subjects who are allergic to any BLI801 component
9. Subjects taking non-opioid medications or supplements known to cause constipation
10. Subjects with an active history of drug or alcohol abuse
11. Subjects who have participated in an investigational clinical, surgical, drug, or device study within the past 30 days
12. Subjects who, in the opinion of the Investigator, should not be included in the study for any reason, including inability to follow study procedures.
13. Subjects who have had a colonoscopy within 2 weeks of Visit 1 or are scheduled to have a colonoscopy during their participation in the study.
14. Subjects who withdraw consent at any time prior to completion of Visit 1 procedures

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BLI801 Laxative (high dose)	Drug: BLI801 Laxative; BLI801 oral laxative
Experimental: BLI801 Laxative (mid dose)	Drug: BLI801 Laxative; BLI801 oral laxative
Experimental: BLI801 Laxative (low dose)	Drug: BLI801 Laxative; BLI801 oral laxative
Placebo Comparator: BLI801 Placebo	Drug: BLI801 Placebo; BLI801 oral laxative placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
% of Subjects With Treatment Response	Treatment response is defined as subjects who are weekly responders for at least 9 out of 12 weeks, with at least 3 of these weeks occurring in the last 4 weeks of treatment. A weekly responder is a subject who has ≥ 3 spontaneous bowel movements (SBMs) and an increase from baseline of > 1 SBM in that week.	12 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
% of subjects with treatment emergent adverse events	12 weeks

Collaborators and Investigators

• Sponsor: Braintree Laboratories
• Investigators: Study Director: John McGowan, Braintree Laboratories, Inc.

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (Actual): April 1, 2017
• Study Completion (Actual): April 1, 2017

Study Registration Dates

• First Submitted: June 30, 2016
• First Submitted That Met QC Criteria: June 30, 2016
• First Posted (Estimated): July 4, 2016

Study Record Updates

• Last Update Posted (Actual): November 7, 2023
• Last Update Submitted That Met QC Criteria: October 18, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Constipation; Gastrointestinal Agents; Laxatives
• Other Study ID Numbers: BLI801-203

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO