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

Completed · Phase 3 · Has a placebo group

Conditions studied: Constipation, Chronic Idiopathic Constipation, CIC

In brief

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

Key facts

Study ID

NCT02819297

Run by

Braintree Laboratories

People needed

1020

Starts

2016-06-01

Expected to finish

2017-06-01

Last updated by the study team

2020-07-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female subjects at least 18 years of age
• Constipated, defined by the following adapted ROME II definition
• Fewer than 3 spontaneous defecations per week and at least one of the following symptoms for at least 12 weeks (which need not be consecutive) in the preceding 12 months:
• Straining during > 25% of defecations
• Lumpy or hard stools in > 25% of defecations
• Sensation of incomplete evacuation for > 25% of defecations
• 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

You may not qualify if…

• 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
• Subjects who are allergic to any study medication component
• Subjects taking narcotic analgesics or other medications known to cause constipation
• Subjects with clinically significant cardiac abnormalities identified at the Visit 1 ECG
• Subjects with clinically significant laboratory abnormalities, deemed as a potential safety issue by the Investigator
• Subjects who, in the opinion of the Investigator, should not be included in the study for any reason, including inability to follow study procedures
• Subjects who have participated in an investigational clinical, surgical, drug, or device study within the past 30 days
• Subjects with an active history of drug or alcohol abuse
• Subjects have been hospitalized for a psychiatric condition or have made a suicide attempt during the 2 years before Visit 1
• Subjects who withdraw consent at any time prior to completion of Visit 1 procedures

Where it is running

• Braintree Research Site 47 — Mobile, Alabama, United States
• Braintree Research Site 28 — Phoenix, Arizona, United States
• Braintree Research Site 4 — Little Rock, Arkansas, United States
• Braintree Research Site 11 — Anaheim, California, United States
• Braintree Research Site 29 — Corona, California, United States
• Braintree Research Site 35 — Garden Grove, California, United States
• Braintree Research Site 32 — La Mirada, California, United States
• Braintree Research Site 50 — Sacramento, California, United States
• Braintree Research Site 51 — Westminster, California, United States
• Braintree Research Site 36 — Denver, Colorado, United States
• Braintree Research Site 45 — Clearwater, Florida, United States
• Braintree Research Site 10 — Hialeah, Florida, United States
• Braintree Research Site 37 — Hialeah, Florida, United States
• Braintree Research Site 39 — Hialeah, Florida, United States
• Braintree Research Site 2 — Miami, Florida, United States
• Braintree Research Site 6 — Miami, Florida, United States
• Braintree Research Site 38 — Miami, Florida, United States
• Braintree Research Site 52 — Miami, Florida, United States
• Braintree Research Site 19 — Miami Lakes, Florida, United States
• Braintree Research Site 44 — Miami Springs, Florida, United States
• Braintree Research Site 13 — Orlando, Florida, United States
• Braintree Research Site 43 — Pembroke Pines, Florida, United States
• Braintree Research Site 25 — Tamarac, Florida, United States
• Braintree Research Site 3 — Tampa, Florida, United States
• Braintree Research Site 8 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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