Clinical trial NCT02822508: A Safety and Efficacy Evaluation of BLI801 Laxative in Adults Experiencing Non-Idiopathic Constipation
Official title: A Safety and Efficacy Evaluation of BLI801 Laxative in Adults Experiencing Non-Idiopathic Constipation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Constipation
Lead sponsor: Braintree Laboratories
Sponsor class: INDUSTRY
First posted: 2016-07-04
Enrollment: 434
Sex: ALL
Minimum age (years): 18
Maximum age (years): 84
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 multiple doses of BLI801 Laxative for safety and efficacy versus placebo in adults experiencing non-idiopathic constipation.


Eligibility criteria: Inclusion Criteria:

1. Male or female subjects between the ages of \> 18 and \< 85 years
2. Constipated, defined by the following criteria: Fewer than 3 spontaneous defecations per week and at least one of the following symptoms for the previous 4 weeks:

   * Straining during \> 25% of defecations
   * Lumpy or hard stools in \> 25% of defecations
   * Sensation of incomplete evacuation for \> 25% of defecations
3. Receiving a stable maintenance opioid regimen.
4. If female, and of child-bearing potential, is using an acceptable form of birth control
5. Negative pregnancy test at screening (Visit 1), if applicable
6. In the Investigator's judgment, subject is mentally competent to provide informed consent to participate in the study

Exclusion Criteria:

1. Subjects with known or suspected ileus, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis or toxic megacolon
2. Subjects who have had major surgery within 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
3. Medical conditions associated with diarrhea, intermittent loose stools or constipation, which could confound the interpretation of the results, eg, fecal incontinence or irritable bowel syndrome. Subjects with irritable bowel syndrome (IBS) that has been previously diagnosed by a physician prior to initiation of the constipating therapy and that meets the following criteria, are excluded:

   1. Absence of a structural or biochemical explanation for the abdominal pain symptom
   2. At least 12 weeks during a period of 12 months, of abdominal discomfort or pain with at least 2 of the following 3 features:

   i. Relieved with defecation, and/or ii. Onset associated with a change in frequency of stool, and/or iii. Onset associated with a change in form of stool.
4. Subjects diagnosed with chronic constipation prior to initiation of opioid treatment
5. Subjects taking laxatives (with the exception of fiber supplements), prokinetic agents or antidiarrheal drugs and refuse to discontinue these treatments from Visit 1 until after completion of Visit 5
6. Subjects who are pregnant or nursing, or intend to become pregnant during the study
7. Subjects of childbearing potential who refuse a pregnancy test
8. Subjects who are allergic to any BLI801 component
9. Subjects taking non-opioid medications or supplements known to cause constipation
10. Subjects with an active history of drug or alcohol abuse
11. Subjects who have participated in an investigational clinical, surgical, drug, or device study within the past 30 days
12. Subjects who, in the opinion of the Investigator, should not be included in the study for any reason, including inability to follow study procedures.
13. Subjects who have had a colonoscopy within 2 weeks of Visit 1 or are scheduled to have a colonoscopy during their participation in the study.
14. Subjects who withdraw consent at any time prior to completion of Visit 1 procedures

Primary outcomes:
measure: % of Subjects With Treatment Response
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Braintree Research Site 43
state: Alabama
city: Peoria
country: United States
facility: Braintree Research Site 30
state: Arizona
city: Phoenix
country: United States
facility: Braintree Research Site 40
state: Arizona
city: Phoenix
country: United States
facility: Braintree Research Site 52
state: Arizona
city: Phoenix
country: United States
facility: Braintree Research Site 26
state: Arizona
city: Fayetteville
country: United States
facility: Braintree Research Site 56
state: Arkansas
city: Little Rock
country: United States
facility: Braintree Research Site 4
state: Arkansas
city: Anaheim
country: United States
facility: Braintree Research Site 51
state: California
city: Fountain Valley
country: United States
facility: Braintree Research Site 54
state: California
city: Fresno
country: United States
facility: Braintree Research Site 8
state: California
city: Long Beach
country: United States
facility: Braintree Research Site 71
state: California
city: Oceanside
country: United States
facility: Braintree Research Site 74
state: California
city: Sacramento
country: United States
facility: Braintree Research Site 59
state: California
city: Sacramento
country: United States
facility: Braintree Research Site 28
state: California
city: Brooksville
country: United States
facility: Braintree Research Site 68
state: Florida
city: Fort Myers
country: United States
facility: Braintree Research Site 36
state: Florida
city: Homestead
country: United States
facility: Braintree Research Site 22
state: Florida
city: Jacksonville
country: United States
facility: Braintree Research Site 5
state: Florida
city: Jacksonville
country: United States
facility: Braintree Research Site 23
state: Florida
city: Miami
country: United States
facility: Braintree Research Site 63
state: Florida
city: Orlando
country: United States
facility: Braintree Research Site 29
state: Florida
city: Orlando
country: United States
facility: Braintree Research Site 65
state: Florida
city: Ormond Beach
country: United States
facility: Braintree Research Site 13
state: Florida
city: Saint Petersburg
country: United States
facility: Braintree Research Site 20
state: Florida
city: Saint Petersburg
country: United States
facility: Braintree Research Site 39
state: Florida
city: Tampa
country: United States
facility: Braintree Research Site 31
state: Florida
city: West Palm Beach
country: United States
facility: Braintree Research Site 41
state: Florida
city: Blue Ridge
country: United States
facility: Braintree Research Site 57
state: Georgia
city: Boise
country: United States
facility: Braintree Research Site 48
state: Idaho
city: Evansville
country: United States
facility: Braintree Research Site 50
state: Indiana
city: Lafayette
country: United States
facility: Braintree Research Site 55
state: Indiana
city: Wichita
country: United States
facility: Braintree Research Site 38
state: Kansas
city: Edgewood
country: United States
facility: Braintree Research Site 64
state: Kentucky
city: Lake Charles
country: United States
facility: Braintree Research Site 73
state: Louisiana
city: Saint Louis
country: United States
facility: Braintree Research Site 49
state: Missouri
city: Omaha
country: United States
facility: Braintree Research Site 19
state: Nebraska
city: Omaha
country: United States
facility: Braintree Research Site 21
state: Nebraska
city: Henderson
country: United States
facility: Braintree Research Site 69
state: Nevada
city: Las Vegas
country: United States
facility: Braintree Research Site 1
state: Nevada
city: Las Vegas
country: United States
facility: Braintree Research Site 44
state: Nevada
city: Las Vegas
country: United States
facility: Braintree Research Site 34
state: Nevada
city: Belvidere
country: United States
facility: Braintree Research Site 7
state: New Jersey
city: Trenton
country: United States
facility: Braintree Research Site 53
state: New Jersey
city: Albuquerque
country: United States
facility: Braintree Research Site 10
state: New Mexico
city: Brooklyn
country: United States
facility: Braintree Research Site 27
state: New York
city: Great Neck
country: United States
facility: Braintree Research Site 25
state: New York
city: Williamsville
country: United States
facility: Braintree Research Site 61
state: New York
city: Greensboro
country: United States
facility: Braintree Research Site 45
state: North Carolina
city: Winston-Salem
country: United States
facility: Braintree Research Site 47
state: North Carolina
city: Beavercreek
country: United States
facility: Braintree Research Site 2
state: Ohio
city: Cincinnati
country: United States
facility: Braintree Research Site 76
state: Ohio
city: Columbus
country: United States
facility: Braintree Research Site 3
state: Ohio
city: Columbus
country: United States
facility: Braintree Research Site 60
state: Ohio
city: Huber Heights
country: United States
facility: Braintree Research Site 14
state: Ohio
city: Oklahoma City
country: United States
facility: Braintree Research Site 46
state: Oklahoma
city: Oklahoma City
country: United States
facility: Braintree Research Site 16
state: Oklahoma
city: Lansdale
country: United States
facility: Braintree Research Site 18
state: Pennsylvania
city: Charleston
country: United States
facility: Braintree Research Site 75
state: South Carolina
city: Greer
country: United States
facility: Braintree Research Site 17
state: South Carolina
city: Myrtle Beach
country: United States
facility: Braintree Research Site 42
state: South Carolina
city: Spartanburg
country: United States
facility: Braintree Research Site 24
state: South Carolina
city: Spartanburg
country: United States
facility: Braintree Research Site 72
state: South Carolina
city: Summerville
country: United States
facility: Braintree Research Site 9
state: South Carolina
city: Chattanooga
country: United States
facility: Braintree Research Site 37
state: Tennessee
city: Tullahoma
country: United States
facility: Braintree Research Site 67
state: Tennessee
city: Austin
country: United States
facility: Braintree Research Site 11
state: Texas
city: Carrollton
country: United States
facility: Braintree Research Site 33
state: Texas
city: Channelview
country: United States
facility: Braintree Research Site 62
state: Texas
city: Houston
country: United States
facility: Braintree Research Site 70
state: Texas
city: Saint George
country: United States
facility: Braintree Research Site 12
state: Utah
city: Salt Lake City
country: United States
facility: Braintree Research Site 35
state: Utah
city: West Jordan
country: United States
facility: Braintree Research Site 66
state: Utah
city: Tacoma
country: United States
facility: Braintree Research Site 6
state: Washington
Study officials:
affiliation: Braintree Laboratories, Inc.
name: John McGowan
role: STUDY_DIRECTOR
References: