Chronic Idiopathic ConstipationPhase 3NCT02481947
A Safety and Efficacy Evaluation of BLI400 Laxative in Constipated Adults
A Phase 3 study testing BLI400 Laxative and Lubiprostone in people with Chronic Idiopathic Constipation, run by Braintree Laboratories at 50 sites in United States.
Trial summary
The purpose of this study is to evaluate a daily dose of BLI400 Laxative for safety and efficacy versus lubiprostone in constipated adults. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Idiopathic Constipation
- What is being tested?
- BLI400 Laxative and Lubiprostone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 459 participants
- Where
- 50 sitesUnited States
- Study dates
- May 2015to Nov 2015
- 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
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- Loose stools are rarely present without the use of laxatives
- 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
Who cannot join
- 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
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- 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)
Trial locations and contacts
50 sites in 1 country.
50 sites in 1 country
United States50 sites
BLI Research Site 10
Anaheim, California, 92801
BLI Research Site 12
Artesia, California, 90701
BLI Research Site 7
Atlanta, Georgia, 30328
BLI Research Site 20
Austin, Texas, 78731
BLI Research Site 9
Austin, Texas, 78735
BLI Research Site 26
Brandon, Florida, 33511
BLI Research Site 4
Brandon, Florida, 33511
BLI Research Site 42
Carrollton, Texas, 75010
BLI Research Site 48
Channelview, Texas, 77530
BLI Research Site 35
Charlottesville, Virginia, 22911
BLI Research Site 22
Chattanooga, Tennessee, 37421
BLI Research Site 16
Chicago, Illinois, 60602
BLI Research Site 14
Cincinnati, Ohio, 45231
BLI Research Site 44
Clearwater, Florida, 33756
BLI Research Site 28
Corona, California, 92879
BLI Research Site 46
DeLand, Florida, 32720
BLI Research Site 32
Hialeah, Florida, 33012
BLI Research Site 40
Hialeah, Florida, 33012
BLI Research Site 29
Knoxville, Tennessee, 37938
BLI Research Site 30
La Mirada, California, 90638
BLI Research Site 13
Laguna Hills, California, 92653
BLI Research Site 49
Las Vegas, Nevada, 89103
BLI Research Site 45
Memphis, Tennessee, 38119
BLI Research Site 5
Miami, Florida, 33142
BLI Research Site 34
Miami, Florida, 33144
BLI Research Site 36
Miami, Florida, 33144
BLI Research Site 8
Miami, Florida, 33144
BLI Research Site 17
Miami Lakes, Florida, 33016
BLI Research Site 43
Miami Springs, Florida, 33166
BLI Research Site 38
Mobile, Alabama, 36688
BLI Research Site 6
Monroe, Louisiana, 71201
BLI Research Site 19
Nashville, Tennessee, 37012
BLI Research Site 27
New York, New York, 10016
BLI Research Site 15
Newport News, Virginia, 23606
BLI Research Site 41
Orange, California, 92868
BLI Research Site 11
Orlando, Florida, 32801
BLI Research Site 18
Orlando, Florida, 32807
BLI Research Site 47
Owensboro, Kentucky, 42303
BLI Research Site 37
Palmetto Bay, Florida, 33157
BLI Research Site 2
Plano, Texas, 75024
BLI Research Site 39
Raleigh, North Carolina, 27609
BLI Research Site 33
Richland, Washington, 99352
BLI Research Site 50
Sacramento, California, 95821
BLI Research Site 23
San Diego, California, 92103
BLI Research Site 25
Snellville, Georgia, 30078
BLI Research Site 24
St. Petersburg, Florida, 33709
BLI Research Site 3
Tampa, Florida, 33607
BLI Research Site 21
Tucson, Arizona, 85712
BLI Research Site 31
West Monroe, Louisiana, 71291
BLI Research Site 1
West Palm Beach, Florida, 33409
About this study
The purpose of this study is to evaluate a daily dose of BLI400 Laxative for safety and efficacy versus lubiprostone in constipated adults.
- Conditions
- Chronic Idiopathic Constipation
- Being tested
- BLI400 Laxative, Lubiprostone
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
LubiprostoneDrug
24 mcg capsule bid
| Study group | Role | What they receive |
|---|---|---|
| BLI400 Laxative | Experimental | 21 gm BLI400 powder Receives: Drug: BLI400 Laxative |
| Lubiprostone | Active comparator | 24 mcg capsule bid Receives: Drug: Lubiprostone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2015 (estimated)
- Study startMay 2015
- Primary completionNov 2015
- Study completionNov 2015
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 Chronic Idiopathic 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 459 participants (actual)
Sponsor and investigators
- Lead sponsor
- Braintree Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John McGowan, MPH, Study director, Braintree Laboratories, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02481947
- Sponsor's protocol ID
- BLI400-301
- Status last verified
- Jul 2020
- First submitted
- 23 Jun 2015
- Last updated
- 27 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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
- A Safety and Efficacy Evaluation of BLI400 Laxative in Constipated Adults
- ClinicalTrials.gov ID
- NCT02481947
- Acronym / sponsor ID
- BLI400-301
- Conditions
- Chronic Idiopathic Constipation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 459 participants (actual)
- Lead sponsor
- Braintree LaboratoriesIndustry (pharma, biotech, devices)
- Study start
- May 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 25 Jun 2015 (estimated)
- Results
- Posted 25 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 purpose of this study is to evaluate a daily dose of BLI400 Laxative for safety and efficacy versus lubiprostone in constipated adults.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BLI400 Laxative | Experimental | Drug: BLI400 Laxative21 gm BLI400 powder |
| Lubiprostone | Active comparator | Drug: Lubiprostone24 mcg capsule bid |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 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:
- Straining during > 25% of defecations
- Lumpy or hard stools in > 25% of defecations
Key exclusion criteria (15 listed)
- 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
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 |
| Lubiprostone24 mcg capsule bid | Drug | Lubiprostone |
Primary outcome
Complete Spontaneous Bowel Movement (CSBM) Response
Time frame: 12 weeks
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.
Results and safety
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.
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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, MPH study director
Braintree Laboratories, Inc.
50 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 and Lubiprostone in people with Chronic Idiopathic Constipation, run by Braintree Laboratories at 50 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 13 inclusion and 15 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 50 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. 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 25 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?
Complete Spontaneous Bowel Movement (CSBM) 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?
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.