CompletedPhase 3

An Open Label Study of Chronic Use of BLI400 Laxative in Constipated Adults

United States330 participantsStarted 2016-06

Plain-language summary

The objective of this study is to evaluate the safety of chronic use of BLI400 laxative 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 (hormonal birth control, IUD, double-barrier method, depot contraceptive, sterilized, abstinent, or vasectomized spouse)
✓. Negative urine 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 Visit 6
✕. Subjects who are pregnant or lactating, or intend to become pregnant during the study
✕. Subjects of childbearing potential who refuse a pregnancy test

% of Subjects With Treatment Emergent Adverse Events

Timeframe: 12 months

NCT IDNCT02819310

SponsorBraintree Laboratories

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-08

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 (hormonal birth control, IUD, double-barrier method, depot contraceptive, sterilized, abstinent, or vasectomized spouse)
✓. Negative urine 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 Visit 6
✕. Subjects who are pregnant or lactating, or intend to become pregnant during the study
✕. Subjects of childbearing potential who refuse a pregnancy test