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

Phase 3

Completed

• Conditions: Constipation; CIC; Chronic Idiopathic Constipation
• Interventions: Drug: BLI400 Placebo; Drug: BLI400 Laxative

• Registration Number: NCT02819297
• Lead Sponsor: Braintree Laboratories

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06
• Study First Submitted: 2016-06-28
• Study First Submitted QC: 2016-06-29
• Study First Posted: 2016-06-30
• Primary Completion: 2017-06
• Study Completion: 2017-06
• Disposition First Submitted: 2018-09-26
• Disposition First Submitted QC: 2018-09-26
• Disposition First Posted: 2018-09-28
• Results First Submitted: 2020-06-09
• Results First Submitted QC: 2020-06-09
• Results First Posted: 2020-06-26
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-10
• Last Update Posted: 2020-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1020

Inclusion Criteria

1. Male or female subjects at least 18 years of age

2. 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

3. If female, and of child-bearing potential, is using an acceptable form of birth control

4. Negative serum pregnancy test at screening, if applicable

5. In the Investigator's judgment, subject is mentally competent to provide informed consent to participate in the study

Exclusion Criteria

1. 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
2. Meet the Rome II criteria for Irritable Bowel Syndrome.
3. Subjects with known or suspected ileus, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis, toxic megacolon
4. 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
5. 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
6. Subjects taking laxatives, enemas or prokinetic agents that refuse to discontinue these treatments from Visit 1 until after completion of the study
7. Subjects who are pregnant or lactating, or intend to become pregnant during the study
8. Subjects of childbearing potential who refuse a pregnancy test
9. Subjects who are allergic to any study medication component
10. Subjects taking narcotic analgesics or other medications known to cause constipation
11. Subjects with clinically significant cardiac abnormalities identified at the Visit 1 ECG
12. Subjects with clinically significant laboratory abnormalities, deemed as a potential safety issue by the Investigator
13. Subjects who, in the opinion of the Investigator, should not be included in the study for any reason, including inability to follow study procedures
14. Subjects who have participated in an investigational clinical, surgical, drug, or device study within the past 30 days
15. Subjects with an active history of drug or alcohol abuse
16. Subjects have been hospitalized for a psychiatric condition or have made a suicide attempt during the 2 years before Visit 1
17. Subjects who withdraw consent at any time prior to completion of Visit 1 procedures

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	BLI400 Placebo	BLI400 placebo
BLI400 Laxative	BLI400 Laxative	BLI400 Laxative

Primary Outcome Measures

Name	Time	Method
Treatment Response	12 weeks	The primary endpoint is the proportion of subjects who are weekly responders for at least 9 out of 12 weeks, with at least 3 of these weeks occurring in the last 4 weeks of treatment. A weekly responder is a subject who has ≥ 3 CSBMs and an increase from baseline of \> 1 CSBM in that week.

Trial Locations

Locations (51)

Braintree Research Site 42; 🇺🇸 West Jordan, Utah, United States

Braintree Research Site 14; 🇺🇸 Newport News, Virginia, United States

Braintree Research Site 30; 🇺🇸 Cleveland, Ohio, United States

Braintree Research Site 40; 🇺🇸 Houston, Texas, United States

Braintree Research Site 32; 🇺🇸 La Mirada, California, United States

Braintree Research Site 29; 🇺🇸 Corona, California, United States

Braintree Research Site 35; 🇺🇸 Garden Grove, California, United States

Braintree Research Site 11; 🇺🇸 Anaheim, California, United States

Braintree Research Site 47; 🇺🇸 Mobile, Alabama, United States

Braintree Research Site 51; 🇺🇸 Westminster, California, 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 19; 🇺🇸 Miami Lakes, Florida, United States

Braintree Research Site 39; 🇺🇸 Hialeah, Florida, United States

Braintree Research Site 2; 🇺🇸 Miami, Florida, United States

Braintree Research Site 38; 🇺🇸 Miami, Florida, United States

Braintree Research Site 44; 🇺🇸 Miami Springs, Florida, United States

Braintree Research Site 6; 🇺🇸 Miami, Florida, United States

Braintree Research Site 52; 🇺🇸 Miami, Florida, United States

Braintree Research Site 43; 🇺🇸 Pembroke Pines, Florida, United States

Braintree Research Site 25; 🇺🇸 Tamarac, Florida, United States

Braintree Research Site 41; 🇺🇸 Atlanta, Georgia, United States

Braintree Research Site 1; 🇺🇸 West Palm Beach, Florida, United States

Braintree Research Site 20; 🇺🇸 Marietta, Georgia, United States

Braintree Research Site 27; 🇺🇸 Snellville, Georgia, United States

Braintree Research Site 15; 🇺🇸 Chicago, Illinois, United States

Braintree Research Site 26; 🇺🇸 Brooklyn, New York, United States

Braintree Research Site 17; 🇺🇸 Hartsdale, New York, United States

Braintree Research Site 21; 🇺🇸 High Point, North Carolina, United States

Braintree Research Site 5; 🇺🇸 Raleigh, North Carolina, United States

Braintree Research Site 48; 🇺🇸 Columbus, Ohio, United States

Braintree Research Site 9; 🇺🇸 Dayton, Ohio, United States

Braintree Research Site 18; 🇺🇸 Smithfield, Pennsylvania, United States

Braintree Research Site 22; 🇺🇸 Chattanooga, Tennessee, United States

Braintree Research Site 31; 🇺🇸 Knoxville, Tennessee, United States

Braintree Research Site 49; 🇺🇸 Norfolk, Virginia, United States

Braintree Research Site 28; 🇺🇸 Phoenix, Arizona, United States

Braintree Research Site 16; 🇺🇸 Cincinnati, Ohio, United States

Braintree Research Site 34; 🇺🇸 San Antonio, Texas, United States

Braintree Research Site 8; 🇺🇸 Birmingham, Alabama, United States

Braintree Research Site 36; 🇺🇸 Denver, Colorado, United States

Braintree Research Site 13; 🇺🇸 Orlando, Florida, United States

Braintree Research Site 24; 🇺🇸 Las Vegas, Nevada, United States

Braintree Research Site 46; 🇺🇸 Meridian, Idaho, United States

Braintree Research Site 23; 🇺🇸 Lancaster, South Carolina, United States

Braintree Research Site 4; 🇺🇸 Little Rock, Arkansas, United States

Braintree Research Site 7; 🇺🇸 Bastrop, Louisiana, United States

Braintree Research Site 50; 🇺🇸 Sacramento, California, United States

Braintree Research Site 3; 🇺🇸 Tampa, Florida, United States

Braintree Research Site 12; 🇺🇸 New Orleans, Louisiana, United States