A Safety and Efficacy Evaluation of BLI400 Laxative in Constipated Adults

NCT02481947 | Completed Phase 3 Results

• 1 other identifier: BLI400-301
• Study Type: interventional
• Target: 459
• Locations: 1 country
• Sites: 50

Brief Summary

The purpose of this study is to evaluate a daily dose of BLI400 Laxative for safety and efficacy versus lubiprostone in constipated adults.

Conditions

Chronic Idiopathic Constipation

Outcome Measures

Primary Outcomes (1)

• Complete Spontaneous Bowel Movement (CSBM) Response

  The primary endpoint is based on the number 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

21 gm BLI400 powder

Drug: BLI400 Laxative

Lubiprostone

ACTIVE COMPARATOR

24 mcg capsule bid

Drug: Lubiprostone

Interventions

BLI400 Laxative DRUG

21 gm BLI400 powder

BLI400 Laxative

Lubiprostone DRUG

24 mcg capsule bid

Lubiprostone

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:
• A. 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
• B. Loose stools are rarely present without the use of laxatives
• C. There are insufficient criteria for IBS - loose (mushy) or watery stool in the absence of laxative use for more than 25% of bowel movements
• Criteria A, B and C must be fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis.
• Otherwise in good health, as determined by physical exam and medical history
• If female, and of child-bearing potential, is using an acceptable form of birth control
• Negative urine 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:

• 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 Visit 5
• 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 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
• Subjects have been hospitalized for a psychiatric condition or have made a suicide attempt during the 2 years before Visit 1
• Subjects who withdraw consent at any time prior to completion of Visit 1 procedures
• Subjects with known or suspected moderate to severe hepatic insufficiency (Child Pugh Classes B and C)

Sponsors & Collaborators

• Braintree Laboratories: lead

Study Sites (50)

BLI Research Site 38

Mobile, Alabama, 36688, United States

Location

BLI Research Site 21

Tucson, Arizona, 85712, United States

Location

BLI Research Site 10

Anaheim, California, 92801, United States

Location

BLI Research Site 12

Artesia, California, 90701, United States

Location

BLI Research Site 28

Corona, California, 92879, United States

Location

BLI Research Site 30

La Mirada, California, 90638, United States

Location

BLI Research Site 13

Laguna Hills, California, 92653, United States

Location

BLI Research Site 41

Orange, California, 92868, United States

Location

BLI Research Site 50

Sacramento, California, 95821, United States

Location

BLI Research Site 23

San Diego, California, 92103, United States

Location

BLI Research Site 26

Brandon, Florida, 33511, United States

Location

BLI Research Site 4

Brandon, Florida, 33511, United States

Location

BLI Research Site 44

Clearwater, Florida, 33756, United States

Location

BLI Research Site 46

DeLand, Florida, 32720, United States

Location

BLI Research Site 32

Hialeah, Florida, 33012, United States

Location

BLI Research Site 40

Hialeah, Florida, 33012, United States

Location

BLI Research Site 5

Miami, Florida, 33142, United States

Location

BLI Research Site 34

Miami, Florida, 33144, United States

Location

BLI Research Site 36

Miami, Florida, 33144, United States

Location

BLI Research Site 8

Miami, Florida, 33144, United States

Location

BLI Research Site 17

Miami Lakes, Florida, 33016, United States

Location

BLI Research Site 43

Miami Springs, Florida, 33166, United States

Location

BLI Research Site 11

Orlando, Florida, 32801, United States

Location

BLI Research Site 18

Orlando, Florida, 32807, United States

Location

BLI Research Site 37

Palmetto Bay, Florida, 33157, United States

Location

BLI Research Site 24

St. Petersburg, Florida, 33709, United States

Location

BLI Research Site 3

Tampa, Florida, 33607, United States

Location

BLI Research Site 1

West Palm Beach, Florida, 33409, United States

Location

BLI Research Site 7

Atlanta, Georgia, 30328, United States

Location

BLI Research Site 25

Snellville, Georgia, 30078, United States

Location

BLI Research Site 16

Chicago, Illinois, 60602, United States

Location

BLI Research Site 47

Owensboro, Kentucky, 42303, United States

Location

BLI Research Site 6

Monroe, Louisiana, 71201, United States

Location

BLI Research Site 31

West Monroe, Louisiana, 71291, United States

Location

BLI Research Site 49

Las Vegas, Nevada, 89103, United States

Location

BLI Research Site 27

New York, New York, 10016, United States

Location

BLI Research Site 39

Raleigh, North Carolina, 27609, United States

Location

BLI Research Site 14

Cincinnati, Ohio, 45231, United States

Location

BLI Research Site 22

Chattanooga, Tennessee, 37421, United States

Location

BLI Research Site 29

Knoxville, Tennessee, 37938, United States

Location

BLI Research Site 45

Memphis, Tennessee, 38119, United States

Location

BLI Research Site 19

Nashville, Tennessee, 37012, United States

Location

BLI Research Site 20

Austin, Texas, 78731, United States

Location

BLI Research Site 9

Austin, Texas, 78735, United States

Location

BLI Research Site 42

Carrollton, Texas, 75010, United States

Location

BLI Research Site 48

Channelview, Texas, 77530, United States

Location

BLI Research Site 2

Plano, Texas, 75024, United States

Location

BLI Research Site 35

Charlottesville, Virginia, 22911, United States

Location

BLI Research Site 15

Newport News, Virginia, 23606, United States

Location

BLI Research Site 33

Richland, Washington, 99352, United States

Location

MeSH Terms

Interventions

Lubiprostone

Intervention Hierarchy (Ancestors)

Alprostadil; Fatty Acids, Monounsaturated; Fatty Acids, Unsaturated; Fatty Acids; Lipids

Results Point of Contact

• Title: Vice President, Clinical Affairs
• Organization: Braintree Laboratories, Inc.

john.mcgowan@sebelapharma.com

781-843-2202

Study Officials

• John McGowan, MPH

  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: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2015
• First Posted: June 25, 2015
• Study Start: May 1, 2015
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: July 27, 2020
• Results First Posted: June 25, 2020

Record last verified: 2020-07

Locations

US (50)