A Safety and Efficacy Evaluation of BLI400 Laxative in Constipated Adults

Phase 3

Completed

• Conditions: Chronic Idiopathic Constipation
• Interventions: Drug: BLI400 Laxative; Drug: Lubiprostone

• Registration Number: NCT02481947
• Lead Sponsor: Braintree Laboratories

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05
• Study First Submitted: 2015-06-23
• Study First Submitted QC: 2015-06-23
• Study First Posted: 2015-06-25
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Disposition First Submitted: 2017-01-30
• Disposition First Submitted QC: 2017-01-30
• Disposition First Posted: 2017-01-31
• Results First Submitted: 2020-06-09
• Results First Submitted QC: 2020-06-09
• Results First Posted: 2020-06-25
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-10
• Last Update Posted: 2020-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 459

Inclusion Criteria

• 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:

1. Straining during > 25% of defecations
2. Lumpy or hard stools in > 25% of defecations
3. 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

Exclusion Criteria

• 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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BLI400 Laxative	BLI400 Laxative	21 gm BLI400 powder
Lubiprostone	Lubiprostone	24 mcg capsule bid

Primary Outcome Measures

Name	Time	Method
Complete Spontaneous Bowel Movement (CSBM) Response	12 weeks	The primary endpoint is based on the number 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 (50)

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

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