A Safety and Efficacy Evaluation of BLI801 Laxative in Adults Experiencing Non-Idiopathic Constipation

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Constipation

In brief

The objective of this study is to evaluate multiple doses of BLI801 Laxative for safety and efficacy versus placebo in adults experiencing non-idiopathic constipation.

Key facts

Study ID

NCT02822508

Run by

Braintree Laboratories

People needed

434

Starts

2016-06-01

Expected to finish

2017-04-01

Last updated by the study team

2023-11-07

Who can join

Age: 18 and older, up to 84. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female subjects between the ages of > 18 and < 85 years
• Constipated, defined by the following criteria: Fewer than 3 spontaneous defecations per week and at least one of the following symptoms for the previous 4 weeks:
• Straining during > 25% of defecations
• Lumpy or hard stools in > 25% of defecations
• Sensation of incomplete evacuation for > 25% of defecations
• Receiving a stable maintenance opioid regimen.
• If female, and of child-bearing potential, is using an acceptable form of birth control
• Negative pregnancy test at screening (Visit 1), 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 or toxic megacolon
• Subjects who have had major surgery within 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
• Medical conditions associated with diarrhea, intermittent loose stools or constipation, which could confound the interpretation of the results, eg, fecal incontinence or irritable bowel syndrome. Subjects with irritable bowel syndrome (IBS) that has been previously diagnosed by a physician prior to initiation of the constipating therapy and that meets the following criteria, are excluded:
• Absence of a structural or biochemical explanation for the abdominal pain symptom
• At least 12 weeks during a period of 12 months, of abdominal discomfort or pain with at least 2 of the following 3 features:
• i. Relieved with defecation, and/or ii. Onset associated with a change in frequency of stool, and/or iii. Onset associated with a change in form of stool.
• Subjects diagnosed with chronic constipation prior to initiation of opioid treatment
• Subjects taking laxatives (with the exception of fiber supplements), prokinetic agents or antidiarrheal drugs and refuse to discontinue these treatments from Visit 1 until after completion of Visit 5
• Subjects who are pregnant or nursing, or intend to become pregnant during the study
• Subjects of childbearing potential who refuse a pregnancy test
• Subjects who are allergic to any BLI801 component
• Subjects taking non-opioid medications or supplements known to cause constipation
• Subjects with an active history of drug or alcohol abuse
• Subjects who have participated in an investigational clinical, surgical, drug, or device study within the past 30 days
• 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 had a colonoscopy within 2 weeks of Visit 1 or are scheduled to have a colonoscopy during their participation in the study.
• Subjects who withdraw consent at any time prior to completion of Visit 1 procedures

Where it is running

• Braintree Research Site 30 — Peoria, Arizona, United States
• Braintree Research Site 40 — Phoenix, Arizona, United States
• Braintree Research Site 52 — Phoenix, Arizona, United States
• Braintree Research Site 26 — Phoenix, Arizona, United States
• Braintree Research Site 56 — Fayetteville, Arkansas, United States
• Braintree Research Site 4 — Little Rock, Arkansas, United States
• Braintree Research Site 51 — Anaheim, California, United States
• Braintree Research Site 54 — Fountain Valley, California, United States
• Braintree Research Site 8 — Fresno, California, United States
• Braintree Research Site 71 — Long Beach, California, United States
• Braintree Research Site 74 — Oceanside, California, United States
• Braintree Research Site 59 — Sacramento, California, United States
• Braintree Research Site 28 — Sacramento, California, United States
• Braintree Research Site 68 — Brooksville, Florida, United States
• Braintree Research Site 36 — Fort Myers, Florida, United States
• Braintree Research Site 22 — Homestead, Florida, United States
• Braintree Research Site 5 — Jacksonville, Florida, United States
• Braintree Research Site 23 — Jacksonville, Florida, United States
• Braintree Research Site 63 — Miami, Florida, United States
• Braintree Research Site 29 — Orlando, Florida, United States
• Braintree Research Site 65 — Orlando, Florida, United States
• Braintree Research Site 13 — Ormond Beach, Florida, United States
• Braintree Research Site 20 — St. Petersburg, Florida, United States
• Braintree Research Site 39 — St. Petersburg, Florida, United States
• Braintree Research Site 43 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.