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

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

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 1020
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35216
      • Braintree Research Site 8
    • Mobile, Alabama, United States, 36688
      • Braintree Research Site 47
  • Arizona
    • Phoenix, Arizona, United States, 85018
      • Braintree Research Site 28
  • Arkansas
    • Little Rock, Arkansas, United States, 72211
      • Braintree Research Site 4
  • California
    • Anaheim, California, United States, 92801
      • Braintree Research Site 11
    • Corona, California, United States, 92879
      • Braintree Research Site 29
    • Garden Grove, California, United States, 92840
      • Braintree Research Site 35
    • La Mirada, California, United States, 90638
      • Braintree Research Site 32
    • Sacramento, California, United States, 95821
      • Braintree Research Site 50
    • Westminster, California, United States, 92638
      • Braintree Research Site 51
  • Colorado
    • Denver, Colorado, United States, 80246
      • Braintree Research Site 36
  • Florida
    • Clearwater, Florida, United States, 33756
      • Braintree Research Site 45
    • Hialeah, Florida, United States, 33012
      • Braintree Research Site 10
    • Hialeah, Florida, United States, 33012
      • Braintree Research Site 37
    • Hialeah, Florida, United States, 33012
      • Braintree Research Site 39
    • Miami, Florida, United States, 33015
      • Braintree Research Site 2
    • Miami, Florida, United States, 33142
      • Braintree Research Site 6
    • Miami, Florida, United States, 33144
      • Braintree Research Site 38
    • Miami, Florida, United States, 33173
      • Braintree Research Site 52
    • Miami Lakes, Florida, United States, 33016
      • Braintree Research Site 19
    • Miami Springs, Florida, United States, 33166
      • Braintree Research Site 44
    • Orlando, Florida, United States, 32801
      • Braintree Research Site 13
    • Pembroke Pines, Florida, United States, 33024
      • Braintree Research Site 43
    • Tamarac, Florida, United States, 33319
      • Braintree Research Site 25
    • Tampa, Florida, United States, 33607
      • Braintree Research Site 3
    • West Palm Beach, Florida, United States, 33409
      • Braintree Research Site 1
  • Georgia
    • Atlanta, Georgia, United States, 30328
      • Braintree Research Site 41
    • Marietta, Georgia, United States, 30060
      • Braintree Research Site 20
    • Snellville, Georgia, United States, 30078
      • Braintree Research Site 27
  • Idaho
    • Meridian, Idaho, United States, 83642
      • Braintree Research Site 46
  • Illinois
    • Chicago, Illinois, United States, 60602
      • Braintree Research Site 15
  • Louisiana
    • Bastrop, Louisiana, United States, 71220
      • Braintree Research Site 7
    • New Orleans, Louisiana, United States, 70124
      • Braintree Research Site 12
  • Nevada
    • Las Vegas, Nevada, United States, 89102
      • Braintree Research Site 24
  • New York
    • Brooklyn, New York, United States, 11230
      • Braintree Research Site 26
    • Hartsdale, New York, United States, 10530
      • Braintree Research Site 17
  • North Carolina
    • High Point, North Carolina, United States, 27262
      • Braintree Research Site 21
    • Raleigh, North Carolina, United States, 27612
      • Braintree Research Site 5
  • Ohio
    • Cincinnati, Ohio, United States, 45215
      • Braintree Research Site 16
    • Cleveland, Ohio, United States, 44122
      • Braintree Research Site 30
    • Columbus, Ohio, United States, 43214
      • Braintree Research Site 48
    • Dayton, Ohio, United States, 45424
      • Braintree Research Site 9
  • Pennsylvania
    • Smithfield, Pennsylvania, United States, 15478
      • Braintree Research Site 18
  • South Carolina
    • Lancaster, South Carolina, United States, 29720
      • Braintree Research Site 23
  • Tennessee
    • Chattanooga, Tennessee, United States, 37421
      • Braintree Research Site 22
    • Knoxville, Tennessee, United States, 37938
      • Braintree Research Site 31
  • Texas
    • Houston, Texas, United States, 77081
      • Braintree Research Site 40
    • San Antonio, Texas, United States, 78209
      • Braintree Research Site 34
  • Utah
    • West Jordan, Utah, United States, 84088
      • Braintree Research Site 42
  • Virginia
    • Newport News, Virginia, United States, 23606
      • Braintree Research Site 14
    • Norfolk, Virginia, United States, 23507
      • Braintree Research Site 49

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:

1. Male or female subjects at least 18 years of age

2. 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
3. If female, and of child-bearing potential, is using an acceptable form of birth control
4. Negative serum pregnancy test at screening, if applicable
5. In the Investigator's judgment, subject is mentally competent to provide informed consent to participate in the study

Exclusion Criteria:

1. 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
2. Meet the Rome II criteria for Irritable Bowel Syndrome.
3. Subjects with known or suspected ileus, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis, toxic megacolon
4. 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
5. 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
6. Subjects taking laxatives, enemas or prokinetic agents that refuse to discontinue these treatments from Visit 1 until after completion of the study
7. Subjects who are pregnant or lactating, or intend to become pregnant during the study
8. Subjects of childbearing potential who refuse a pregnancy test
9. Subjects who are allergic to any study medication component
10. Subjects taking narcotic analgesics or other medications known to cause constipation
11. Subjects with clinically significant cardiac abnormalities identified at the Visit 1 ECG
12. Subjects with clinically significant laboratory abnormalities, deemed as a potential safety issue by the Investigator
13. Subjects who, in the opinion of the Investigator, should not be included in the study for any reason, including inability to follow study procedures
14. Subjects who have participated in an investigational clinical, surgical, drug, or device study within the past 30 days
15. Subjects with an active history of drug or alcohol abuse
16. Subjects have been hospitalized for a psychiatric condition or have made a suicide attempt during the 2 years before Visit 1
17. Subjects who withdraw consent at any time prior to completion of Visit 1 procedures

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BLI400 Laxative	Drug: BLI400 Laxative; 21 gm BLI400 powder
Placebo Comparator: Placebo; BLI400 placebo	Drug: BLI400 Placebo; Equivalent amount of placebo powder

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Braintree Laboratories

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (Actual): June 1, 2017
• Study Completion (Actual): June 1, 2017

Study Registration Dates

• First Submitted: June 28, 2016
• First Submitted That Met QC Criteria: June 29, 2016
• First Posted (Estimate): June 30, 2016

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; Gastrointestinal Agents; Laxatives
• Other Study ID Numbers: BLI400-302

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO