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

Constipation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02822508
• Other study ID #: BLI801-203
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: June 2016
• Est. completion date: April 2017

Study information

• Verified date: October 2023
• Source: Braintree Laboratories
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 434
• Est. completion date: April 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 84 Years

Eligibility

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

Related Conditions & MeSH terms

• Constipation

Intervention

Drug:
• BLI801 Laxative
BLI801 oral laxative
• BLI801 Placebo
BLI801 oral laxative placebo

Locations

Country	Name	City	State
United States	Braintree Research Site 10	Albuquerque	New Mexico
United States	Braintree Research Site 51	Anaheim	California
United States	Braintree Research Site 11	Austin	Texas
United States	Braintree Research Site 2	Beavercreek	Ohio
United States	Braintree Research Site 7	Belvidere	New Jersey
United States	Braintree Research Site 43	Birmingham	Alabama
United States	Braintree Research Site 57	Blue Ridge	Georgia
United States	Braintree Research Site 48	Boise	Idaho
United States	Braintree Research Site 27	Brooklyn	New York
United States	Braintree Research Site 68	Brooksville	Florida
United States	Braintree Research Site 33	Carrollton	Texas
United States	Braintree Research Site 62	Channelview	Texas
United States	Braintree Research Site 75	Charleston	South Carolina
United States	Braintree Research Site 37	Chattanooga	Tennessee
United States	Braintree Research Site 76	Cincinnati	Ohio
United States	Braintree Research Site 3	Columbus	Ohio
United States	Braintree Research Site 60	Columbus	Ohio
United States	Braintree Research Site 64	Edgewood	Kentucky
United States	Braintree Research Site 50	Evansville	Indiana
United States	Braintree Research Site 56	Fayetteville	Arkansas
United States	Braintree Research Site 36	Fort Myers	Florida
United States	Braintree Research Site 54	Fountain Valley	California
United States	Braintree Research Site 8	Fresno	California
United States	Braintree Research Site 25	Great Neck	New York
United States	Braintree Research Site 45	Greensboro	North Carolina
United States	Braintree Research Site 17	Greer	South Carolina
United States	Braintree Research Site 69	Henderson	Nevada
United States	Braintree Research Site 22	Homestead	Florida
United States	Braintree Research Site 70	Houston	Texas
United States	Braintree Research Site 14	Huber Heights	Ohio
United States	Braintree Research Site 23	Jacksonville	Florida
United States	Braintree Research Site 5	Jacksonville	Florida
United States	Braintree Research Site 55	Lafayette	Indiana
United States	Braintree Research Site 73	Lake Charles	Louisiana
United States	Braintree Research Site 18	Lansdale	Pennsylvania
United States	Braintree Research Site 1	Las Vegas	Nevada
United States	Braintree Research Site 34	Las Vegas	Nevada
United States	Braintree Research Site 44	Las Vegas	Nevada
United States	Braintree Research Site 4	Little Rock	Arkansas
United States	Braintree Research Site 71	Long Beach	California
United States	Braintree Research Site 63	Miami	Florida
United States	Braintree Research Site 42	Myrtle Beach	South Carolina
United States	Braintree Research Site 74	Oceanside	California
United States	Braintree Research Site 16	Oklahoma City	Oklahoma
United States	Braintree Research Site 46	Oklahoma City	Oklahoma
United States	Braintree Research Site 19	Omaha	Nebraska
United States	Braintree Research Site 21	Omaha	Nebraska
United States	Braintree Research Site 29	Orlando	Florida
United States	Braintree Research Site 65	Orlando	Florida
United States	Braintree Research Site 13	Ormond Beach	Florida
United States	Braintree Research Site 30	Peoria	Arizona
United States	Braintree Research Site 26	Phoenix	Arizona
United States	Braintree Research Site 40	Phoenix	Arizona
United States	Braintree Research Site 52	Phoenix	Arizona
United States	Braintree Research Site 28	Sacramento	California
United States	Braintree Research Site 59	Sacramento	California
United States	Braintree Research Site 12	Saint George	Utah
United States	Braintree Research Site 49	Saint Louis	Missouri
United States	Braintree Research Site 20	Saint Petersburg	Florida
United States	Braintree Research Site 39	Saint Petersburg	Florida
United States	Braintree Research Site 35	Salt Lake City	Utah
United States	Braintree Research Site 24	Spartanburg	South Carolina
United States	Braintree Research Site 72	Spartanburg	South Carolina
United States	Braintree Research Site 9	Summerville	South Carolina
United States	Braintree Research Site 6	Tacoma	Washington
United States	Braintree Research Site 31	Tampa	Florida
United States	Braintree Research Site 53	Trenton	New Jersey
United States	Braintree Research Site 67	Tullahoma	Tennessee
United States	Braintree Research Site 66	West Jordan	Utah
United States	Braintree Research Site 41	West Palm Beach	Florida
United States	Braintree Research Site 38	Wichita	Kansas
United States	Braintree Research Site 61	Williamsville	New York
United States	Braintree Research Site 47	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Braintree Laboratories

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	% 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