BLI400-302: A Safety and Efficacy Evaluation of BLI400 Laxative in Constipated Adults

NCT02819297 | Completed Phase 3 Results

• 1 other identifier: BLI400-302
• Study Type: interventional
• Target: 1,020
• Locations: 1 country
• Sites: 51

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.

Conditions

Constipation; Chronic Idiopathic Constipation; CIC

Outcome Measures

Primary Outcomes (1)

• Treatment Response

  The primary endpoint is the proportion of 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 CSBMs and an increase from baseline of \> 1 CSBM in that week.

  12 weeks

Study Arms (2)

BLI400 Laxative

EXPERIMENTAL

BLI400 Laxative

Drug: BLI400 Laxative

Placebo

PLACEBO COMPARATOR

BLI400 placebo

Drug: BLI400 Placebo

Interventions

BLI400 Laxative DRUG

21 gm BLI400 powder

BLI400 Laxative

BLI400 Placebo DRUG

Equivalent amount of placebo powder

Placebo

Eligibility Criteria

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

You may qualify if:

• Male or female subjects at least 18 years of age
• 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
• If female, and of child-bearing potential, is using an acceptable form of birth control
• Negative serum pregnancy test at screening, 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:

• 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
• Meet the Rome II criteria for Irritable Bowel Syndrome.
• 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 the study
• 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 with clinically significant laboratory abnormalities, deemed as a potential safety issue by the Investigator
• 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

Sponsors & Collaborators

• Braintree Laboratories: lead

Study Sites (51)

Braintree Research Site 8

Birmingham, Alabama, 35216, United States

Location

Braintree Research Site 47

Mobile, Alabama, 36688, United States

Location

Braintree Research Site 28

Phoenix, Arizona, 85018, United States

Location

Braintree Research Site 4

Little Rock, Arkansas, 72211, United States

Location

Braintree Research Site 11

Anaheim, California, 92801, United States

Location

Braintree Research Site 29

Corona, California, 92879, United States

Location

Braintree Research Site 35

Garden Grove, California, 92840, United States

Location

Braintree Research Site 32

La Mirada, California, 90638, United States

Location

Braintree Research Site 50

Sacramento, California, 95821, United States

Location

Braintree Research Site 51

Westminster, California, 92638, United States

Location

Braintree Research Site 36

Denver, Colorado, 80246, United States

Location

Braintree Research Site 45

Clearwater, Florida, 33756, United States

Location

Braintree Research Site 10

Hialeah, Florida, 33012, United States

Location

Braintree Research Site 37

Hialeah, Florida, 33012, United States

Location

Braintree Research Site 39

Hialeah, Florida, 33012, United States

Location

Braintree Research Site 2

Miami, Florida, 33015, United States

Location

Braintree Research Site 6

Miami, Florida, 33142, United States

Location

Braintree Research Site 38

Miami, Florida, 33144, United States

Location

Braintree Research Site 52

Miami, Florida, 33173, United States

Location

Braintree Research Site 19

Miami Lakes, Florida, 33016, United States

Location

Braintree Research Site 44

Miami Springs, Florida, 33166, United States

Location

Braintree Research Site 13

Orlando, Florida, 32801, United States

Location

Braintree Research Site 43

Pembroke Pines, Florida, 33024, United States

Location

Braintree Research Site 25

Tamarac, Florida, 33319, United States

Location

Braintree Research Site 3

Tampa, Florida, 33607, United States

Location

Braintree Research Site 1

West Palm Beach, Florida, 33409, United States

Location

Braintree Research Site 41

Atlanta, Georgia, 30328, United States

Location

Braintree Research Site 20

Marietta, Georgia, 30060, United States

Location

Braintree Research Site 27

Snellville, Georgia, 30078, United States

Location

Braintree Research Site 46

Meridian, Idaho, 83642, United States

Location

Braintree Research Site 15

Chicago, Illinois, 60602, United States

Location

Braintree Research Site 7

Bastrop, Louisiana, 71220, United States

Location

Braintree Research Site 12

New Orleans, Louisiana, 70124, United States

Location

Braintree Research Site 24

Las Vegas, Nevada, 89102, United States

Location

Braintree Research Site 26

Brooklyn, New York, 11230, United States

Location

Braintree Research Site 17

Hartsdale, New York, 10530, United States

Location

Braintree Research Site 21

High Point, North Carolina, 27262, United States

Location

Braintree Research Site 5

Raleigh, North Carolina, 27612, United States

Location

Braintree Research Site 16

Cincinnati, Ohio, 45215, United States

Location

Braintree Research Site 30

Cleveland, Ohio, 44122, United States

Location

Braintree Research Site 48

Columbus, Ohio, 43214, United States

Location

Braintree Research Site 9

Dayton, Ohio, 45424, United States

Location

Braintree Research Site 18

Smithfield, Pennsylvania, 15478, United States

Location

Braintree Research Site 23

Lancaster, South Carolina, 29720, United States

Location

Braintree Research Site 22

Chattanooga, Tennessee, 37421, United States

Location

Braintree Research Site 31

Knoxville, Tennessee, 37938, United States

Location

Braintree Research Site 40

Houston, Texas, 77081, United States

Location

Braintree Research Site 34

San Antonio, Texas, 78209, United States

Location

Braintree Research Site 42

West Jordan, Utah, 84088, United States

Location

Braintree Research Site 14

Newport News, Virginia, 23606, United States

Location

Braintree Research Site 49

Norfolk, Virginia, 23507, 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: VP, Clinical Affairs
• Organization: Braintree Laboratories, Inc.

john.mcgowan@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 3
• 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 28, 2016
• First Posted: June 30, 2016
• Study Start: June 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: July 27, 2020
• Results First Posted: June 26, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (51)