Clinical trial NCT02819297: BLI400-302: A Safety and Efficacy Evaluation of BLI400 Laxative in Constipated Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Constipation
Chronic Idiopathic Constipation
CIC
Lead sponsor: Braintree Laboratories
Sponsor class: INDUSTRY
First posted: 2016-06-30
Enrollment: 1020
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 objective of this study is to evaluate a daily dose of BLI400 Laxative for safety and efficacy versus placebo in constipated adults.


Eligibility criteria: 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

Primary outcomes:
measure: Treatment Response
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Braintree Research Site 8
state: Alabama
city: Mobile
country: United States
facility: Braintree Research Site 47
state: Alabama
city: Phoenix
country: United States
facility: Braintree Research Site 28
state: Arizona
city: Little Rock
country: United States
facility: Braintree Research Site 4
state: Arkansas
city: Anaheim
country: United States
facility: Braintree Research Site 11
state: California
city: Corona
country: United States
facility: Braintree Research Site 29
state: California
city: Garden Grove
country: United States
facility: Braintree Research Site 35
state: California
city: La Mirada
country: United States
facility: Braintree Research Site 32
state: California
city: Sacramento
country: United States
facility: Braintree Research Site 50
state: California
city: Westminster
country: United States
facility: Braintree Research Site 51
state: California
city: Denver
country: United States
facility: Braintree Research Site 36
state: Colorado
city: Clearwater
country: United States
facility: Braintree Research Site 45
state: Florida
city: Hialeah
country: United States
facility: Braintree Research Site 10
state: Florida
city: Hialeah
country: United States
facility: Braintree Research Site 37
state: Florida
city: Hialeah
country: United States
facility: Braintree Research Site 39
state: Florida
city: Miami Lakes
country: United States
facility: Braintree Research Site 19
state: Florida
city: Miami Springs
country: United States
facility: Braintree Research Site 44
state: Florida
city: Miami
country: United States
facility: Braintree Research Site 2
state: Florida
city: Miami
country: United States
facility: Braintree Research Site 6
state: Florida
city: Miami
country: United States
facility: Braintree Research Site 38
state: Florida
city: Miami
country: United States
facility: Braintree Research Site 52
state: Florida
city: Orlando
country: United States
facility: Braintree Research Site 13
state: Florida
city: Pembroke Pines
country: United States
facility: Braintree Research Site 43
state: Florida
city: Tamarac
country: United States
facility: Braintree Research Site 25
state: Florida
city: Tampa
country: United States
facility: Braintree Research Site 3
state: Florida
city: West Palm Beach
country: United States
facility: Braintree Research Site 1
state: Florida
city: Atlanta
country: United States
facility: Braintree Research Site 41
state: Georgia
city: Marietta
country: United States
facility: Braintree Research Site 20
state: Georgia
city: Snellville
country: United States
facility: Braintree Research Site 27
state: Georgia
city: Meridian
country: United States
facility: Braintree Research Site 46
state: Idaho
city: Chicago
country: United States
facility: Braintree Research Site 15
state: Illinois
city: Bastrop
country: United States
facility: Braintree Research Site 7
state: Louisiana
city: New Orleans
country: United States
facility: Braintree Research Site 12
state: Louisiana
city: Las Vegas
country: United States
facility: Braintree Research Site 24
state: Nevada
city: Brooklyn
country: United States
facility: Braintree Research Site 26
state: New York
city: Hartsdale
country: United States
facility: Braintree Research Site 17
state: New York
city: High Point
country: United States
facility: Braintree Research Site 21
state: North Carolina
city: Raleigh
country: United States
facility: Braintree Research Site 5
state: North Carolina
city: Cincinnati
country: United States
facility: Braintree Research Site 16
state: Ohio
city: Cleveland
country: United States
facility: Braintree Research Site 30
state: Ohio
city: Columbus
country: United States
facility: Braintree Research Site 48
state: Ohio
city: Dayton
country: United States
facility: Braintree Research Site 9
state: Ohio
city: Smithfield
country: United States
facility: Braintree Research Site 18
state: Pennsylvania
city: Lancaster
country: United States
facility: Braintree Research Site 23
state: South Carolina
city: Chattanooga
country: United States
facility: Braintree Research Site 22
state: Tennessee
city: Knoxville
country: United States
facility: Braintree Research Site 31
state: Tennessee
city: Houston
country: United States
facility: Braintree Research Site 40
state: Texas
city: San Antonio
country: United States
facility: Braintree Research Site 34
state: Texas
city: West Jordan
country: United States
facility: Braintree Research Site 42
state: Utah
city: Newport News
country: United States
facility: Braintree Research Site 14
state: Virginia
city: Norfolk
country: United States
facility: Braintree Research Site 49
state: Virginia
Study officials:
affiliation: Braintree Laboratories, Inc.
name: John McGowan
role: STUDY_DIRECTOR
References: