ConstipationPhase 3NCT02819297

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

A Phase 3 study testing BLI400 Laxative in people with Constipation and Chronic Idiopathic Constipation, run by Braintree Laboratories at 51 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 18 years and older
Conditions the study is for: Constipation, Chronic Idiopathic Constipation, CIC
What is being tested?: BLI400 Laxative
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1,020 participants
Where: 51 sitesUnited States
Study dates: Jun 2016to Jun 2017
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Show all 9Show fewer

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

Who cannot join

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 the study

Show all 17Show fewer

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 with clinically significant laboratory abnormalities, deemed as a potential safety issue by the Investigator
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

Trial locations and contacts

51 sites in 1 country.

City, postcode or hospital

51 sites in 1 country

United States51 sites

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

Other trials in United States

About this study

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

Conditions: Constipation, Chronic Idiopathic Constipation, CIC
Being tested: BLI400 Laxative, BLI400 Placebo
Medical subject headings: Constipation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BLI400 LaxativeDrug
21 gm BLI400 powder
BLI400 PlaceboDrug
Equivalent amount of placebo powder

Study groups in NCT02819297
Study group	Role	What they receive
BLI400 Laxative	Experimental	BLI400 Laxative Receives: Drug: BLI400 Laxative
Placebo	Placebo comparator	BLI400 placebo Receives: Drug: BLI400 Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2016Jun 2017

First posted30 Jun 2016 (estimated)
Study startJun 2016
Primary completionJun 2017
Study completionJun 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for ConstipationStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 1,020 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02819297
Sponsor's protocol ID: BLI400-302
Status last verified: Jul 2020
First submitted: 28 Jun 2016
Last updated: 27 Jul 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Outcome Research in Bowel Irrigation Techniques for the Treatment of Chronic Constipation and/or Faecal Incontinence
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This is a Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study of the Efficacy and Safety of 2 Weight-based Treatment Groups of Plecanatide Versus Placebo in Children and Adolescent Participants 6 to Less Than 18 Years of Age With FC
Functional Constipation (FC)
Not yet recruiting
Acupuncture Combined With Transcutaneous Electrical Acupoint Stimulation for Constipation-Predominant Irritable Bowel Syndrome With Anxiety State
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All Constipation trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: BLI400-302: A Safety and Efficacy Evaluation of BLI400 Laxative in Constipated Adults
ClinicalTrials.gov ID: NCT02819297
Acronym / sponsor ID: BLI400-302
Conditions: Constipation, Chronic Idiopathic Constipation, CIC
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,020 participants (actual)
Lead sponsor: Braintree LaboratoriesIndustry (pharma, biotech, devices)
Study start: Jun 2016
Primary completion: Jun 2017 (actual)
Study completion: Jun 2017 (actual)
First posted: 30 Jun 2016 (estimated)
Results: Posted 26 Jun 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
BLI400 Laxative	Experimental	Drug: BLI400 LaxativeBLI400 Laxative
Placebo	Placebo comparator	Drug: BLI400 PlaceboBLI400 placebo

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

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:
If female, and of child-bearing potential, is using an acceptable form of birth control
Negative serum pregnancy test at screening, if applicable

Key exclusion criteria (17 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BLI400 Laxative21 gm BLI400 powder	Drug	BLI400 Laxative
BLI400 PlaceboEquivalent amount of placebo powder	Drug	Placebo

Primary outcome

Treatment Response
Time frame: 12 weeks
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.

Results and safety

Results posted to the registry on 26 Jun 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
BLI400 Laxative	299	239
Placebo	304	252

Primary outcome: Treatment Response

Time frame: 12 weeks. Count of participants. Unit: Participants

Measure	BLI400 Laxative n = 294	Placebo n = 302
Value	77	39

BLI400 Laxative vs Placebo: p <0.001, Cochran-Mantel-Haenszel

Population analysed: modified ITT population - excludes subjects with significant protocol violations

Adverse events

Time frame: 6 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
BLI400 Laxative	3 of 299 (1%)	42 of 299 (14%)	0 of 299
Placebo	8 of 304 (2.6%)	33 of 304 (10.9%)	0 of 304

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Constipation

Recruiting
Effects of a Prebiotic-Probiotic Combination on Constipation Symptoms and Quality of Life
Constipation, Abdominal Pain
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C)
Irritable Bowel Syndrome, Constipation
Recruiting
Outcome Research in Bowel Irrigation Techniques for the Treatment of Chronic Constipation and/or Faecal Incontinence
Faecal Incontinence, Chronic Constipation
Active, not recruitingPhase 2
This is a Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study of the Efficacy and Safety of 2 Weight-based Treatment Groups of Plecanatide Versus Placebo in Children and Adolescent Participants 6 to Less Than 18 Years of Age With FC
Functional Constipation (FC)
Not yet recruiting
Acupuncture Combined With Transcutaneous Electrical Acupoint Stimulation for Constipation-Predominant Irritable Bowel Syndrome With Anxiety State
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

John McGowan study director

Braintree Laboratories, Inc.

51 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing BLI400 Laxative in people with Constipation and Chronic Idiopathic Constipation, run by Braintree Laboratories at 51 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 51 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Treatment Response (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02819297.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2020.