A Safety and Efficacy Evaluation of BLI801 Laxative in Adults Experiencing Non-Idiopathic Constipation

NCT02822508 | Completed Phase 2 Results

• 1 other identifier: BLI801-203
• Study Type: interventional
• Target: 434
• Locations: 1 country
• Sites: 73

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.

Conditions

Constipation

Outcome Measures

Primary Outcomes (1)

• % of Subjects With Treatment Response

  Treatment response is defined as 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 spontaneous bowel movements (SBMs) and an increase from baseline of \> 1 SBM in that week.

  12 weeks

Study Arms (4)

BLI801 Laxative (high dose)

EXPERIMENTAL

BLI801 Laxative (high dose)

Drug: BLI801 Laxative

BLI801 Laxative (mid dose)

EXPERIMENTAL

BLI801 Laxative (mid dose)

Drug: BLI801 Laxative

BLI801 Laxative (low dose)

EXPERIMENTAL

BLI801 Laxative (low dose)

Drug: BLI801 Laxative

BLI801 Placebo

PLACEBO COMPARATOR

BLI801 Placebo

Drug: BLI801 Placebo

Interventions

BLI801 Laxative DRUG

BLI801 oral laxative

BLI801 Laxative (high dose); BLI801 Laxative (low dose); BLI801 Laxative (mid dose)

BLI801 Placebo DRUG

BLI801 oral laxative placebo

BLI801 Placebo

Eligibility Criteria

• Age: 18 Years - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects between the ages of \> 18 and \< 85 years
• 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
• Receiving a stable maintenance opioid regimen.
• If female, and of child-bearing potential, is using an acceptable form of birth control
• Negative pregnancy test at screening (Visit 1), if applicable
• In the Investigator's judgment, subject is mentally competent to provide informed consent to participate in the study

You may not qualify if:

• Subjects with known or suspected ileus, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis or toxic megacolon
• 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
• 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:
• Absence of a structural or biochemical explanation for the abdominal pain symptom
• 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.
• Subjects diagnosed with chronic constipation prior to initiation of opioid treatment
• 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
• Subjects who are pregnant or nursing, or intend to become pregnant during the study
• Subjects of childbearing potential who refuse a pregnancy test
• Subjects who are allergic to any BLI801 component
• Subjects taking non-opioid medications or supplements known to cause constipation
• Subjects with an active history of drug or alcohol abuse
• Subjects who have participated in an investigational clinical, surgical, drug, or device study within the past 30 days
• Subjects who, in the opinion of the Investigator, should not be included in the study for any reason, including inability to follow study procedures.

Sponsors & Collaborators

• Braintree Laboratories: lead

Study Sites (73)

Braintree Research Site 43

Birmingham, Alabama, 35209, United States

Location

Braintree Research Site 30

Peoria, Arizona, 85381, United States

Location

Braintree Research Site 40

Phoenix, Arizona, 85018, United States

Location

Braintree Research Site 52

Phoenix, Arizona, 85020, United States

Location

Braintree Research Site 26

Phoenix, Arizona, 85029, United States

Location

Braintree Research Site 56

Fayetteville, Arkansas, 72703, United States

Location

Braintree Research Site 4

Little Rock, Arkansas, 72211, United States

Location

Braintree Research Site 51

Anaheim, California, 92801, United States

Location

Braintree Research Site 54

Fountain Valley, California, 92708, United States

Location

Braintree Research Site 8

Fresno, California, 93710, United States

Location

Braintree Research Site 71

Long Beach, California, 90806, United States

Location

Braintree Research Site 74

Oceanside, California, 92056, United States

Location

Braintree Research Site 59

Sacramento, California, 95821, United States

Location

Braintree Research Site 28

Sacramento, California, 95842, United States

Location

Braintree Research Site 68

Brooksville, Florida, 34601, United States

Location

Braintree Research Site 36

Fort Myers, Florida, 33912, United States

Location

Braintree Research Site 22

Homestead, Florida, 33030, United States

Location

Braintree Research Site 5

Jacksonville, Florida, 32218, United States

Location

Braintree Research Site 23

Jacksonville, Florida, 32257, United States

Location

Braintree Research Site 63

Miami, Florida, 33186, United States

Location

Braintree Research Site 29

Orlando, Florida, 32801, United States

Location

Braintree Research Site 65

Orlando, Florida, 32806, United States

Location

Braintree Research Site 13

Ormond Beach, Florida, 32174, United States

Location

Braintree Research Site 20

St. Petersburg, Florida, 33709, United States

Location

Braintree Research Site 39

St. Petersburg, Florida, 33709, United States

Location

Braintree Research Site 31

Tampa, Florida, 33634, United States

Location

Braintree Research Site 41

West Palm Beach, Florida, 33409, United States

Location

Braintree Research Site 57

Blue Ridge, Georgia, 30513, United States

Location

Braintree Research Site 48

Boise, Idaho, 83713, United States

Location

Braintree Research Site 50

Evansville, Indiana, 47714, United States

Location

Braintree Research Site 55

Lafayette, Indiana, 47905, United States

Location

Braintree Research Site 38

Wichita, Kansas, 67203, United States

Location

Braintree Research Site 64

Edgewood, Kentucky, 41017, United States

Location

Braintree Research Site 73

Lake Charles, Louisiana, 70601, United States

Location

Braintree Research Site 49

St Louis, Missouri, 63042, United States

Location

Braintree Research Site 19

Omaha, Nebraska, 68114, United States

Location

Braintree Research Site 21

Omaha, Nebraska, 68134, United States

Location

Braintree Research Site 69

Henderson, Nevada, 89014, United States

Location

Braintree Research Site 1

Las Vegas, Nevada, 89119, United States

Location

Braintree Research Site 44

Las Vegas, Nevada, 89119, United States

Location

Braintree Research Site 34

Las Vegas, Nevada, 89123, United States

Location

Braintree Research Site 7

Belvidere, New Jersey, 07823, United States

Location

Braintree Research Site 53

Trenton, New Jersey, 08611, United States

Location

Braintree Research Site 10

Albuquerque, New Mexico, 87102, United States

Location

Braintree Research Site 27

Brooklyn, New York, 11235, United States

Location

Braintree Research Site 25

Great Neck, New York, 11023, United States

Location

Braintree Research Site 61

Williamsville, New York, 14221, United States

Location

Braintree Research Site 45

Greensboro, North Carolina, 27410, United States

Location

Braintree Research Site 47

Winston-Salem, North Carolina, 27103, United States

Location

Braintree Research Site 2

Beavercreek, Ohio, 45432, United States

Location

Braintree Research Site 76

Cincinnati, Ohio, 45215, United States

Location

Braintree Research Site 3

Columbus, Ohio, 43213, United States

Location

Braintree Research Site 60

Columbus, Ohio, 43214, United States

Location

Braintree Research Site 14

Huber Heights, Ohio, 45424, United States

Location

Braintree Research Site 46

Oklahoma City, Oklahoma, 73109, United States

Location

Braintree Research Site 16

Oklahoma City, Oklahoma, 73119, United States

Location

Braintree Research Site 18

Lansdale, Pennsylvania, 19446, United States

Location

Braintree Research Site 75

Charleston, South Carolina, 29406, United States

Location

Braintree Research Site 17

Greer, South Carolina, 29651, United States

Location

Braintree Research Site 42

Myrtle Beach, South Carolina, 29588, United States

Location

Braintree Research Site 24

Spartanburg, South Carolina, 29303, United States

Location

Braintree Research Site 72

Spartanburg, South Carolina, 29307, United States

Location

Braintree Research Site 9

Summerville, South Carolina, 29485, United States

Location

Braintree Research Site 37

Chattanooga, Tennessee, 37421, United States

Location

Braintree Research Site 67

Tullahoma, Tennessee, 37388, United States

Location

Braintree Research Site 11

Austin, Texas, 78705, United States

Location

Braintree Research Site 33

Carrollton, Texas, 75007, United States

Location

Braintree Research Site 62

Channelview, Texas, 77530, United States

Location

Braintree Research Site 70

Houston, Texas, 77058, United States

Location

Braintree Research Site 35

Salt Lake City, Utah, 84107, United States

Location

Braintree Research Site 12

St. George, Utah, 84790, United States

Location

Braintree Research Site 66

West Jordan, Utah, 84088, United States

Location

Braintree Research Site 6

Tacoma, Washington, 98405, United States

Location

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Head of R&D, Gastroenterology
• Organization: Braintree Laboratories, Inc.

studydirector@sebelapharma.com

781-843-2202

Study Officials

• John McGowan

  Braintree Laboratories, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2016
• First Posted: July 4, 2016
• Study Start: June 1, 2016
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: November 7, 2023
• Results First Posted: November 7, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (73)