CompletedPhase 3

BLI400-302: A Safety and Efficacy Evaluation of BLI400 Laxative in Constipated Adults

United States1,020 participantsStarted 2016-06

Plain-language summary

The objective of this study is to evaluate a daily dose of BLI400 Laxative for safety and efficacy versus placebo in constipated adults.

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Male or female subjects at least 18 years of age
✓. Constipated, defined by the following adapted ROME II definition
✓. If female, and of child-bearing potential, is using an acceptable form of birth control
✓. Negative serum pregnancy test at screening, if applicable
✓. In the Investigator's judgment, subject is mentally competent to provide informed consent to participate in the study

✕. Report loose (mushy) or water stools in the absence of laxative use for more than 25% of BMs during the 12 weeks before Visit 1
✕. Meet the Rome II criteria for Irritable Bowel Syndrome.
✕. Subjects with known or suspected ileus, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis, toxic megacolon
✕. Subjects who have had major surgery 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
✕. Subjects with hypothyroidism that is being treated and for which the dose of thyroid hormone has not been stable for at least 6 weeks at the time of Visit 1
✕. Subjects taking laxatives, enemas or prokinetic agents that refuse to discontinue these treatments from Visit 1 until after completion of the study
✕. Subjects who are pregnant or lactating, or intend to become pregnant during the study
✕. Subjects of childbearing potential who refuse a pregnancy test

Treatment Response

Timeframe: 12 weeks

NCT IDNCT02819297

SponsorBraintree Laboratories

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-06

Results submitted2020-06-09

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Male or female subjects at least 18 years of age
✓. Constipated, defined by the following adapted ROME II definition
✓. If female, and of child-bearing potential, is using an acceptable form of birth control
✓. Negative serum pregnancy test at screening, if applicable
✓. In the Investigator's judgment, subject is mentally competent to provide informed consent to participate in the study

✕. Report loose (mushy) or water stools in the absence of laxative use for more than 25% of BMs during the 12 weeks before Visit 1
✕. Meet the Rome II criteria for Irritable Bowel Syndrome.
✕. Subjects with known or suspected ileus, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis, toxic megacolon
✕. Subjects who have had major surgery 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
✕. Subjects with hypothyroidism that is being treated and for which the dose of thyroid hormone has not been stable for at least 6 weeks at the time of Visit 1
✕. Subjects taking laxatives, enemas or prokinetic agents that refuse to discontinue these treatments from Visit 1 until after completion of the study
✕. Subjects who are pregnant or lactating, or intend to become pregnant during the study
✕. Subjects of childbearing potential who refuse a pregnancy test