An Open Label Study of Chronic Use of BLI400 Laxative in Constipated Adults

The objective of this study is to evaluate the safety of chronic use of BLI400 laxative in constipated adults.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 330
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • Corona, California, United States, 92879
      • Braintree Research Site 14
  • Florida
    • Brandon, Florida, United States, 33511
      • Braintree Research Site 13
    • Brandon, Florida, United States, 33511
      • Braintree Research Site 3
    • Hialeah, Florida, United States, 33012
      • Braintree Research Site 18
    • Hialeah, Florida, United States, 33012
      • Braintree Research Site 19
    • Miami, Florida, United States, 33135
      • Braintree Research Site 4
    • Miami, Florida, United States, 33142
      • Braintree Research Site 5
    • Miami, Florida, United States, 33173
      • Braintree Research Site 16
    • Miami Lakes, Florida, United States, 33016
      • Braintree Research Site 8
    • Palmetto Bay, Florida, United States, 33157
      • Braintree Research Site 17
    • Saint Petersburg, Florida, United States, 33709
      • Braintree Research Site 12
    • West Palm Beach, Florida, United States, 33409
      • Braintree Research Site 2
  • Kentucky
    • Owensboro, Kentucky, United States, 42303
      • Braintree Research Site 24
  • Louisiana
    • Lake Charles, Louisiana, United States, 70601
      • Braintree Research Site 15
  • Nevada
    • Las Vegas, Nevada, United States, 89103
      • Braintree Research Site 25
  • North Carolina
    • Fayetteville, North Carolina, United States, 28314
      • Braintree Research Site 21
  • Ohio
    • Cincinnati, Ohio, United States, 45224
      • Braintree Research Site 6
  • Tennessee
    • Chattanooga, Tennessee, United States, 37421
      • Braintree Research Site 11
    • Memphis, Tennessee, United States, 38119
      • Braintree Research Site 22
    • Nashville, Tennessee, United States, 37211
      • Braintree Research Site 10
  • Texas
    • Carrollton, Texas, United States, 75010
      • Braintree Research Site 20
    • Houston, Texas, United States, 77099
      • Braintree Research Site 23
    • Plano, Texas, United States, 75093
      • Braintree Research Site 1
  • Virginia
    • Newport News, Virginia, United States, 23606
      • Braintree Research Site 7

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 (hormonal birth control, IUD, double-barrier method, depot contraceptive, sterilized, abstinent, or vasectomized spouse)
4. Negative urine 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 Visit 6
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 BLI400 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, may be discontinued at the Investigator's discretion.
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: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BLI400 Laxative	Drug: BLI400 Laxative; oral laxative

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
% of Subjects With Treatment Emergent Adverse Events	% of subjects experiencing a treatment emergent adverse event during the 12 month treatment period	12 months

Collaborators and Investigators

• Sponsor: Braintree Laboratories

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Actual): August 1, 2017
• Study Completion (Actual): August 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 9, 2020
• Last Update Submitted That Met QC Criteria: June 25, 2020
• Last Verified: June 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: BLI400-303

Plan for Individual participant data (IPD)

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