Clinical trial NCT02819310: An Open Label Study of Chronic Use of BLI400 Laxative in Constipated Adults
Official title: An Open Label Study of Chronic Use 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: 330
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate the safety of chronic use of BLI400 laxative 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 (hormonal birth control, IUD, double-barrier method, depot contraceptive, sterilized, abstinent, or vasectomized spouse)
4. Negative urine 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 Visit 6
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 BLI400 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, may be discontinued at the Investigator's discretion.
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: % of Subjects With Treatment Emergent Adverse Events
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Corona
country: United States
facility: Braintree Research Site 14
state: California
city: Brandon
country: United States
facility: Braintree Research Site 13
state: Florida
city: Brandon
country: United States
facility: Braintree Research Site 3
state: Florida
city: Hialeah
country: United States
facility: Braintree Research Site 18
state: Florida
city: Hialeah
country: United States
facility: Braintree Research Site 19
state: Florida
city: Miami Lakes
country: United States
facility: Braintree Research Site 8
state: Florida
city: Miami
country: United States
facility: Braintree Research Site 4
state: Florida
city: Miami
country: United States
facility: Braintree Research Site 5
state: Florida
city: Miami
country: United States
facility: Braintree Research Site 16
state: Florida
city: Palmetto Bay
country: United States
facility: Braintree Research Site 17
state: Florida
city: Saint Petersburg
country: United States
facility: Braintree Research Site 12
state: Florida
city: West Palm Beach
country: United States
facility: Braintree Research Site 2
state: Florida
city: Owensboro
country: United States
facility: Braintree Research Site 24
state: Kentucky
city: Lake Charles
country: United States
facility: Braintree Research Site 15
state: Louisiana
city: Las Vegas
country: United States
facility: Braintree Research Site 25
state: Nevada
city: Fayetteville
country: United States
facility: Braintree Research Site 21
state: North Carolina
city: Cincinnati
country: United States
facility: Braintree Research Site 6
state: Ohio
city: Chattanooga
country: United States
facility: Braintree Research Site 11
state: Tennessee
city: Memphis
country: United States
facility: Braintree Research Site 22
state: Tennessee
city: Nashville
country: United States
facility: Braintree Research Site 10
state: Tennessee
city: Carrollton
country: United States
facility: Braintree Research Site 20
state: Texas
city: Houston
country: United States
facility: Braintree Research Site 23
state: Texas
city: Plano
country: United States
facility: Braintree Research Site 1
state: Texas
city: Newport News
country: United States
facility: Braintree Research Site 7
state: Virginia
Study officials:
affiliation: Braintree Laboratories, Inc.
name: John McGowan
role: STUDY_DIRECTOR
References: