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

Completed · Phase 3

Conditions studied: Constipation, Chronic Idiopathic Constipation, CIC

In brief

The objective of this study is to evaluate the safety of chronic use of BLI400 laxative in constipated adults.

Key facts

Study ID

NCT02819310

Run by

Braintree Laboratories

People needed

330

Starts

2016-06-01

Expected to finish

2017-08-01

Last updated by the study team

2020-07-09

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 (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

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 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
• Subjects who are allergic to any BLI400 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, may be discontinued at the Investigator's discretion.
• 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 14 — Corona, California, United States
• Braintree Research Site 13 — Brandon, Florida, United States
• Braintree Research Site 3 — Brandon, Florida, United States
• Braintree Research Site 18 — Hialeah, Florida, United States
• Braintree Research Site 19 — Hialeah, Florida, United States
• Braintree Research Site 4 — Miami, Florida, United States
• Braintree Research Site 5 — Miami, Florida, United States
• Braintree Research Site 16 — Miami, Florida, United States
• Braintree Research Site 8 — Miami Lakes, Florida, United States
• Braintree Research Site 17 — Palmetto Bay, Florida, United States
• Braintree Research Site 12 — St. Petersburg, Florida, United States
• Braintree Research Site 2 — West Palm Beach, Florida, United States
• Braintree Research Site 24 — Owensboro, Kentucky, United States
• Braintree Research Site 15 — Lake Charles, Louisiana, United States
• Braintree Research Site 25 — Las Vegas, Nevada, United States
• Braintree Research Site 21 — Fayetteville, North Carolina, United States
• Braintree Research Site 6 — Cincinnati, Ohio, United States
• Braintree Research Site 11 — Chattanooga, Tennessee, United States
• Braintree Research Site 22 — Memphis, Tennessee, United States
• Braintree Research Site 10 — Nashville, Tennessee, United States
• Braintree Research Site 20 — Carrollton, Texas, United States
• Braintree Research Site 23 — Houston, Texas, United States
• Braintree Research Site 1 — Plano, Texas, United States
• Braintree Research Site 7 — Newport News, Virginia, United States

Full record on ClinicalTrials.gov

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