A Safety and Efficacy Evaluation of BLI400 Laxative in Constipated Adults

Chronic Idiopathic Constipation Clinical Trial

Official title:

A Safety and Efficacy Evaluation of BLI400 Laxative in Constipated Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02481947
• Other study ID #: BLI400-301
• Status: Completed
• Phase: Phase 3
• Start date: May 2015
• Est. completion date: November 2015

Study information

• Verified date: July 2020
• Source: Braintree Laboratories
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 459
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Chronic Idiopathic Constipation
• Constipation

Intervention

Drug:
• BLI400 Laxative
21 gm BLI400 powder
• Lubiprostone
24 mcg capsule bid

Locations

Country	Name	City	State
United States	BLI Research Site 10	Anaheim	California
United States	BLI Research Site 12	Artesia	California
United States	BLI Research Site 7	Atlanta	Georgia
United States	BLI Research Site 20	Austin	Texas
United States	BLI Research Site 9	Austin	Texas
United States	BLI Research Site 26	Brandon	Florida
United States	BLI Research Site 4	Brandon	Florida
United States	BLI Research Site 42	Carrollton	Texas
United States	BLI Research Site 48	Channelview	Texas
United States	BLI Research Site 35	Charlottesville	Virginia
United States	BLI Research Site 22	Chattanooga	Tennessee
United States	BLI Research Site 16	Chicago	Illinois
United States	BLI Research Site 14	Cincinnati	Ohio
United States	BLI Research Site 44	Clearwater	Florida
United States	BLI Research Site 28	Corona	California
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 29	Knoxville	Tennessee
United States	BLI Research Site 30	La Mirada	California
United States	BLI Research Site 13	Laguna Hills	California
United States	BLI Research Site 49	Las Vegas	Nevada
United States	BLI Research Site 45	Memphis	Tennessee
United States	BLI Research Site 34	Miami	Florida
United States	BLI Research Site 36	Miami	Florida
United States	BLI Research Site 5	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 38	Mobile	Alabama
United States	BLI Research Site 6	Monroe	Louisiana
United States	BLI Research Site 19	Nashville	Tennessee
United States	BLI Research Site 27	New York	New York
United States	BLI Research Site 15	Newport News	Virginia
United States	BLI Research Site 41	Orange	California
United States	BLI Research Site 11	Orlando	Florida
United States	BLI Research Site 18	Orlando	Florida
United States	BLI Research Site 47	Owensboro	Kentucky
United States	BLI Research Site 37	Palmetto Bay	Florida
United States	BLI Research Site 2	Plano	Texas
United States	BLI Research Site 39	Raleigh	North Carolina
United States	BLI Research Site 33	Richland	Washington
United States	BLI Research Site 50	Sacramento	California
United States	BLI Research Site 24	Saint Petersburg	Florida
United States	BLI Research Site 23	San Diego	California
United States	BLI Research Site 25	Snellville	Georgia
United States	BLI Research Site 3	Tampa	Florida
United States	BLI Research Site 21	Tucson	Arizona
United States	BLI Research Site 31	West Monroe	Louisiana
United States	BLI Research Site 1	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Braintree Laboratories

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete Spontaneous Bowel Movement (CSBM) Response	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.	12 weeks