Clinical trial NCT02481947: A Safety and Efficacy Evaluation of BLI400 Laxative in Constipated Adults
Official title: A Safety and Efficacy Evaluation of BLI400 Laxative in Constipated Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Idiopathic Constipation
Lead sponsor: Braintree Laboratories
Sponsor class: INDUSTRY
First posted: 2015-06-25
Enrollment: 459
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Complete Spontaneous Bowel Movement (CSBM) Response
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Mobile
country: United States
facility: BLI Research Site 38
state: Alabama
city: Tucson
country: United States
facility: BLI Research Site 21
state: Arizona
city: Anaheim
country: United States
facility: BLI Research Site 10
state: California
city: Artesia
country: United States
facility: BLI Research Site 12
state: California
city: Corona
country: United States
facility: BLI Research Site 28
state: California
city: La Mirada
country: United States
facility: BLI Research Site 30
state: California
city: Laguna Hills
country: United States
facility: BLI Research Site 13
state: California
city: Orange
country: United States
facility: BLI Research Site 41
state: California
city: Sacramento
country: United States
facility: BLI Research Site 50
state: California
city: San Diego
country: United States
facility: BLI Research Site 23
state: California
city: Brandon
country: United States
facility: BLI Research Site 26
state: Florida
city: Brandon
country: United States
facility: BLI Research Site 4
state: Florida
city: Clearwater
country: United States
facility: BLI Research Site 44
state: Florida
city: DeLand
country: United States
facility: BLI Research Site 46
state: Florida
city: Hialeah
country: United States
facility: BLI Research Site 32
state: Florida
city: Hialeah
country: United States
facility: BLI Research Site 40
state: Florida
city: Miami Lakes
country: United States
facility: BLI Research Site 17
state: Florida
city: Miami Springs
country: United States
facility: BLI Research Site 43
state: Florida
city: Miami
country: United States
facility: BLI Research Site 5
state: Florida
city: Miami
country: United States
facility: BLI Research Site 34
state: Florida
city: Miami
country: United States
facility: BLI Research Site 36
state: Florida
city: Miami
country: United States
facility: BLI Research Site 8
state: Florida
city: Orlando
country: United States
facility: BLI Research Site 11
state: Florida
city: Orlando
country: United States
facility: BLI Research Site 18
state: Florida
city: Palmetto Bay
country: United States
facility: BLI Research Site 37
state: Florida
city: Saint Petersburg
country: United States
facility: BLI Research Site 24
state: Florida
city: Tampa
country: United States
facility: BLI Research Site 3
state: Florida
city: West Palm Beach
country: United States
facility: BLI Research Site 1
state: Florida
city: Atlanta
country: United States
facility: BLI Research Site 7
state: Georgia
city: Snellville
country: United States
facility: BLI Research Site 25
state: Georgia
city: Chicago
country: United States
facility: BLI Research Site 16
state: Illinois
city: Owensboro
country: United States
facility: BLI Research Site 47
state: Kentucky
city: Monroe
country: United States
facility: BLI Research Site 6
state: Louisiana
city: West Monroe
country: United States
facility: BLI Research Site 31
state: Louisiana
city: Las Vegas
country: United States
facility: BLI Research Site 49
state: Nevada
city: New York
country: United States
facility: BLI Research Site 27
state: New York
city: Raleigh
country: United States
facility: BLI Research Site 39
state: North Carolina
city: Cincinnati
country: United States
facility: BLI Research Site 14
state: Ohio
city: Chattanooga
country: United States
facility: BLI Research Site 22
state: Tennessee
city: Knoxville
country: United States
facility: BLI Research Site 29
state: Tennessee
city: Memphis
country: United States
facility: BLI Research Site 45
state: Tennessee
city: Nashville
country: United States
facility: BLI Research Site 19
state: Tennessee
city: Austin
country: United States
facility: BLI Research Site 20
state: Texas
city: Austin
country: United States
facility: BLI Research Site 9
state: Texas
city: Carrollton
country: United States
facility: BLI Research Site 42
state: Texas
city: Channelview
country: United States
facility: BLI Research Site 48
state: Texas
city: Plano
country: United States
facility: BLI Research Site 2
state: Texas
city: Charlottesville
country: United States
facility: BLI Research Site 35
state: Virginia
city: Newport News
country: United States
facility: BLI Research Site 15
state: Virginia
city: Richland
country: United States
facility: BLI Research Site 33
state: Washington
Study officials:
affiliation: Braintree Laboratories, Inc.
name: John McGowan, MPH
role: STUDY_DIRECTOR
References: