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

NCT02819310 | Completed Phase 3 Results

• 1 other identifier: BLI400-303
• Study Type: interventional
• Target: 330
• Locations: 1 country
• Sites: 24

Brief Summary

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

Conditions

Constipation; Chronic Idiopathic Constipation; CIC

Outcome Measures

Primary Outcomes (1)

• % of Subjects With Treatment Emergent Adverse Events

  % of subjects experiencing a treatment emergent adverse event during the 12 month treatment period

  12 months

Study Arms (1)

BLI400 Laxative

EXPERIMENTAL

BLI400 Laxative

Drug: BLI400 Laxative

Interventions

BLI400 Laxative DRUG

oral laxative

BLI400 Laxative

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 (hormonal birth control, IUD, double-barrier method, depot contraceptive, sterilized, abstinent, or vasectomized spouse)
• 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:

• 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 Visit 6
• 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 BLI400 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, may be discontinued at the Investigator's discretion.
• 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 (24)

Braintree Research Site 14

Corona, California, 92879, United States

Location

Braintree Research Site 13

Brandon, Florida, 33511, United States

Location

Braintree Research Site 3

Brandon, Florida, 33511, United States

Location

Braintree Research Site 18

Hialeah, Florida, 33012, United States

Location

Braintree Research Site 19

Hialeah, Florida, 33012, United States

Location

Braintree Research Site 4

Miami, Florida, 33135, United States

Location

Braintree Research Site 5

Miami, Florida, 33142, United States

Location

Braintree Research Site 16

Miami, Florida, 33173, United States

Location

Braintree Research Site 8

Miami Lakes, Florida, 33016, United States

Location

Braintree Research Site 17

Palmetto Bay, Florida, 33157, United States

Location

Braintree Research Site 12

St. Petersburg, Florida, 33709, United States

Location

Braintree Research Site 2

West Palm Beach, Florida, 33409, United States

Location

Braintree Research Site 24

Owensboro, Kentucky, 42303, United States

Location

Braintree Research Site 15

Lake Charles, Louisiana, 70601, United States

Location

Braintree Research Site 25

Las Vegas, Nevada, 89103, United States

Location

Braintree Research Site 21

Fayetteville, North Carolina, 28314, United States

Location

Braintree Research Site 6

Cincinnati, Ohio, 45224, United States

Location

Braintree Research Site 11

Chattanooga, Tennessee, 37421, United States

Location

Braintree Research Site 22

Memphis, Tennessee, 38119, United States

Location

Braintree Research Site 10

Nashville, Tennessee, 37211, United States

Location

Braintree Research Site 20

Carrollton, Texas, 75010, United States

Location

Braintree Research Site 23

Houston, Texas, 77099, United States

Location

Braintree Research Site 1

Plano, Texas, 75093, United States

Location

Braintree Research Site 7

Newport News, Virginia, 23606, 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: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• 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: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: July 9, 2020
• Results First Posted: June 26, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (24)