A Safety and Efficacy Evaluation of BLI400 Laxative in Constipated Adults

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

Study Overview

• Status: Completed
• Conditions: Chronic Idiopathic Constipation
• Intervention / Treatment: Drug: BLI400 Laxative; Drug: Lubiprostone

• Study Type: Interventional
• Enrollment (Actual): 459
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Mobile, Alabama, United States, 36688
      • BLI Research Site 38
  • Arizona
    • Tucson, Arizona, United States, 85712
      • BLI Research Site 21
  • California
    • Anaheim, California, United States, 92801
      • BLI Research Site 10
    • Artesia, California, United States, 90701
      • BLI Research Site 12
    • Corona, California, United States, 92879
      • BLI Research Site 28
    • La Mirada, California, United States, 90638
      • BLI Research Site 30
    • Laguna Hills, California, United States, 92653
      • BLI Research Site 13
    • Orange, California, United States, 92868
      • BLI Research Site 41
    • Sacramento, California, United States, 95821
      • BLI Research Site 50
    • San Diego, California, United States, 92103
      • BLI Research Site 23
  • Florida
    • Brandon, Florida, United States, 33511
      • BLI Research Site 26
    • Brandon, Florida, United States, 33511
      • BLI Research Site 4
    • Clearwater, Florida, United States, 33756
      • BLI Research Site 44
    • DeLand, Florida, United States, 32720
      • BLI Research Site 46
    • Hialeah, Florida, United States, 33012
      • BLI Research Site 32
    • Hialeah, Florida, United States, 33012
      • BLI Research Site 40
    • Miami, Florida, United States, 33142
      • BLI Research Site 5
    • Miami, Florida, United States, 33144
      • BLI Research Site 34
    • Miami, Florida, United States, 33144
      • BLI Research Site 36
    • Miami, Florida, United States, 33144
      • BLI Research Site 8
    • Miami Lakes, Florida, United States, 33016
      • BLI Research Site 17
    • Miami Springs, Florida, United States, 33166
      • BLI Research Site 43
    • Orlando, Florida, United States, 32801
      • BLI Research Site 11
    • Orlando, Florida, United States, 32807
      • BLI Research Site 18
    • Palmetto Bay, Florida, United States, 33157
      • BLI Research Site 37
    • Saint Petersburg, Florida, United States, 33709
      • BLI Research Site 24
    • Tampa, Florida, United States, 33607
      • BLI Research Site 3
    • West Palm Beach, Florida, United States, 33409
      • BLI Research Site 1
  • Georgia
    • Atlanta, Georgia, United States, 30328
      • BLI Research Site 7
    • Snellville, Georgia, United States, 30078
      • BLI Research Site 25
  • Illinois
    • Chicago, Illinois, United States, 60602
      • BLI Research Site 16
  • Kentucky
    • Owensboro, Kentucky, United States, 42303
      • BLI Research Site 47
  • Louisiana
    • Monroe, Louisiana, United States, 71201
      • BLI Research Site 6
    • West Monroe, Louisiana, United States, 71291
      • BLI Research Site 31
  • Nevada
    • Las Vegas, Nevada, United States, 89103
      • BLI Research Site 49
  • New York
    • New York, New York, United States, 10016
      • BLI Research Site 27
  • North Carolina
    • Raleigh, North Carolina, United States, 27609
      • BLI Research Site 39
  • Ohio
    • Cincinnati, Ohio, United States, 45231
      • BLI Research Site 14
  • Tennessee
    • Chattanooga, Tennessee, United States, 37421
      • BLI Research Site 22
    • Knoxville, Tennessee, United States, 37938
      • BLI Research Site 29
    • Memphis, Tennessee, United States, 38119
      • BLI Research Site 45
    • Nashville, Tennessee, United States, 37012
      • BLI Research Site 19
  • Texas
    • Austin, Texas, United States, 78731
      • BLI Research Site 20
    • Austin, Texas, United States, 78735
      • BLI Research Site 9
    • Carrollton, Texas, United States, 75010
      • BLI Research Site 42
    • Channelview, Texas, United States, 77530
      • BLI Research Site 48
    • Plano, Texas, United States, 75024
      • BLI Research Site 2
  • Virginia
    • Charlottesville, Virginia, United States, 22911
      • BLI Research Site 35
    • Newport News, Virginia, United States, 23606
      • BLI Research Site 15
  • Washington
    • Richland, Washington, United States, 99352
      • BLI Research Site 33

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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:

1. Straining during > 25% of defecations
2. Lumpy or hard stools in > 25% of defecations
3. 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

Exclusion Criteria:

• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: BLI400 Laxative; 21 gm BLI400 powder	Drug: BLI400 Laxative; 21 gm BLI400 powder
ACTIVE_COMPARATOR: Lubiprostone; 24 mcg capsule bid	Drug: Lubiprostone; 24 mcg capsule bid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Braintree Laboratories

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (ACTUAL): November 1, 2015
• Study Completion (ACTUAL): November 1, 2015

Study Registration Dates

• First Submitted: June 23, 2015
• First Submitted That Met QC Criteria: June 23, 2015
• First Posted (ESTIMATE): June 25, 2015

Study Record Updates

• Last Update Posted (ACTUAL): July 27, 2020
• Last Update Submitted That Met QC Criteria: July 10, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Constipation; Molecular Mechanisms of Pharmacological Action; Gastrointestinal Agents; Membrane Transport Modulators; Chloride Channel Agonists; Lubiprostone; Laxatives
• Other Study ID Numbers: BLI400-301