A Safety and Efficacy Evaluation of BLI400 Laxative in Constipated Adults

Completed · Phase 3

Conditions studied: Chronic Idiopathic Constipation

In brief

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

Key facts

Study ID

NCT02481947

Run by

Braintree Laboratories

People needed

459

Starts

2015-05-01

Expected to finish

2015-11-01

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:
• A. 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
• B. Loose stools are rarely present without the use of laxatives
• C. There are insufficient criteria for IBS - loose (mushy) or watery stool in the absence of laxative use for more than 25% of bowel movements
• Criteria A, B and C must be fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis.
• Otherwise in good health, as determined by physical exam and medical history
• If female, and of child-bearing potential, is using an acceptable form of birth control
• 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

You may not qualify if…

• 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 5
• 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 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
• Subjects with known or suspected moderate to severe hepatic insufficiency (Child Pugh Classes B and C)

Where it is running

• BLI Research Site 38 — Mobile, Alabama, United States
• BLI Research Site 21 — Tucson, Arizona, United States
• BLI Research Site 10 — Anaheim, California, United States
• BLI Research Site 12 — Artesia, California, United States
• BLI Research Site 28 — Corona, California, United States
• BLI Research Site 30 — La Mirada, California, United States
• BLI Research Site 13 — Laguna Hills, California, United States
• BLI Research Site 41 — Orange, California, United States
• BLI Research Site 50 — Sacramento, California, United States
• BLI Research Site 23 — San Diego, California, United States
• BLI Research Site 26 — Brandon, Florida, United States
• BLI Research Site 4 — Brandon, Florida, United States
• BLI Research Site 44 — Clearwater, Florida, United States
• BLI Research Site 46 — DeLand, Florida, United States
• BLI Research Site 32 — Hialeah, Florida, United States
• BLI Research Site 40 — Hialeah, Florida, United States
• BLI Research Site 5 — Miami, Florida, United States
• BLI Research Site 34 — Miami, Florida, United States
• BLI Research Site 36 — Miami, Florida, United States
• BLI Research Site 8 — Miami, Florida, United States
• BLI Research Site 17 — Miami Lakes, Florida, United States
• BLI Research Site 43 — Miami Springs, Florida, United States
• BLI Research Site 11 — Orlando, Florida, United States
• BLI Research Site 18 — Orlando, Florida, United States
• BLI Research Site 37 — Palmetto Bay, Florida, United States

Full record on ClinicalTrials.gov

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