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ConstipationPhase 2/3NCT02822508

A Safety and Efficacy Evaluation of BLI801 Laxative in Adults Experiencing Non-Idiopathic Constipation

A Phase 2/3 study testing BLI801 Laxative in people with Constipation, run by Braintree Laboratories at 73 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 multiple doses of BLI801 Laxative for safety and efficacy versus placebo in adults experiencing non-idiopathic constipation. Read more about this study

Who is it for?
Ages 18 to 84 years
Conditions the study is for
Constipation
What is being tested?
BLI801 Laxative
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
434 participants
Where
73 sitesUnited States
Study dates
Jun 2016to Apr 2017
Phase
Phase 2/3
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 to 84 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female subjects between the ages of > 18 and < 85 years
  • Constipated, defined by the following criteria: Fewer than 3 spontaneous defecations per week and at least one of the following symptoms for the previous 4 weeks:
  • Straining during > 25% of defecations
  • Lumpy or hard stools in > 25% of defecations
  • Sensation of incomplete evacuation for > 25% of defecations
  • Receiving a stable maintenance opioid regimen.
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  • If female, and of child-bearing potential, is using an acceptable form of birth control
  • Negative pregnancy test at screening (Visit 1), 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 or toxic megacolon
  • Subjects who have had major surgery within 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
  • Medical conditions associated with diarrhea, intermittent loose stools or constipation, which could confound the interpretation of the results, eg, fecal incontinence or irritable bowel syndrome. Subjects with irritable bowel syndrome (IBS) that has been previously diagnosed by a physician prior to initiation of the constipating therapy and that meets the following criteria, are excluded:
  • Absence of a structural or biochemical explanation for the abdominal pain symptom
  • At least 12 weeks during a period of 12 months, of abdominal discomfort or pain with at least 2 of the following 3 features:
  • Relieved with defecation, and/or ii. Onset associated with a change in frequency of stool, and/or iii. Onset associated with a change in form of stool.
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  • Subjects diagnosed with chronic constipation prior to initiation of opioid treatment
  • Subjects taking laxatives (with the exception of fiber supplements), prokinetic agents or antidiarrheal drugs and refuse to discontinue these treatments from Visit 1 until after completion of Visit 5
  • Subjects who are pregnant or nursing, or intend to become pregnant during the study
  • Subjects of childbearing potential who refuse a pregnancy test
  • Subjects who are allergic to any BLI801 component
  • Subjects taking non-opioid medications or supplements known to cause constipation
  • Subjects with an active history of drug or alcohol abuse
  • Subjects who have participated in an investigational clinical, surgical, drug, or device study within the past 30 days
  • 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 had a colonoscopy within 2 weeks of Visit 1 or are scheduled to have a colonoscopy during their participation in the study.
  • Subjects who withdraw consent at any time prior to completion of Visit 1 procedures

Trial locations and contacts

73 sites in 1 country.

73 sites in 1 country

United States73 sites

  • Braintree Research Site 10

    Albuquerque, New Mexico, 87102

  • Braintree Research Site 51

    Anaheim, California, 92801

  • Braintree Research Site 11

    Austin, Texas, 78705

  • Braintree Research Site 2

    Beavercreek, Ohio, 45432

  • Braintree Research Site 7

    Belvidere, New Jersey, 07823

  • Braintree Research Site 43

    Birmingham, Alabama, 35209

  • Braintree Research Site 57

    Blue Ridge, Georgia, 30513

  • Braintree Research Site 48

    Boise, Idaho, 83713

  • Braintree Research Site 27

    Brooklyn, New York, 11235

  • Braintree Research Site 68

    Brooksville, Florida, 34601

  • Braintree Research Site 33

    Carrollton, Texas, 75007

  • Braintree Research Site 62

    Channelview, Texas, 77530

  • Braintree Research Site 75

    Charleston, South Carolina, 29406

  • Braintree Research Site 37

    Chattanooga, Tennessee, 37421

  • Braintree Research Site 76

    Cincinnati, Ohio, 45215

  • Braintree Research Site 3

    Columbus, Ohio, 43213

  • Braintree Research Site 60

    Columbus, Ohio, 43214

  • Braintree Research Site 64

    Edgewood, Kentucky, 41017

  • Braintree Research Site 50

    Evansville, Indiana, 47714

  • Braintree Research Site 56

    Fayetteville, Arkansas, 72703

  • Braintree Research Site 36

    Fort Myers, Florida, 33912

  • Braintree Research Site 54

    Fountain Valley, California, 92708

  • Braintree Research Site 8

    Fresno, California, 93710

  • Braintree Research Site 25

    Great Neck, New York, 11023

  • Braintree Research Site 45

    Greensboro, North Carolina, 27410

  • Braintree Research Site 17

    Greer, South Carolina, 29651

  • Braintree Research Site 69

    Henderson, Nevada, 89014

  • Braintree Research Site 22

    Homestead, Florida, 33030

  • Braintree Research Site 70

    Houston, Texas, 77058

  • Braintree Research Site 14

    Huber Heights, Ohio, 45424

  • Braintree Research Site 5

    Jacksonville, Florida, 32218

  • Braintree Research Site 23

    Jacksonville, Florida, 32257

  • Braintree Research Site 55

    Lafayette, Indiana, 47905

  • Braintree Research Site 73

    Lake Charles, Louisiana, 70601

  • Braintree Research Site 18

    Lansdale, Pennsylvania, 19446

  • Braintree Research Site 1

    Las Vegas, Nevada, 89119

  • Braintree Research Site 44

    Las Vegas, Nevada, 89119

  • Braintree Research Site 34

    Las Vegas, Nevada, 89123

  • Braintree Research Site 4

    Little Rock, Arkansas, 72211

  • Braintree Research Site 71

    Long Beach, California, 90806

  • Braintree Research Site 63

    Miami, Florida, 33186

  • Braintree Research Site 42

    Myrtle Beach, South Carolina, 29588

  • Braintree Research Site 74

    Oceanside, California, 92056

  • Braintree Research Site 46

    Oklahoma City, Oklahoma, 73109

  • Braintree Research Site 16

    Oklahoma City, Oklahoma, 73119

  • Braintree Research Site 19

    Omaha, Nebraska, 68114

  • Braintree Research Site 21

    Omaha, Nebraska, 68134

  • Braintree Research Site 29

    Orlando, Florida, 32801

  • Braintree Research Site 65

    Orlando, Florida, 32806

  • Braintree Research Site 13

    Ormond Beach, Florida, 32174

  • Braintree Research Site 30

    Peoria, Arizona, 85381

  • Braintree Research Site 40

    Phoenix, Arizona, 85018

  • Braintree Research Site 52

    Phoenix, Arizona, 85020

  • Braintree Research Site 26

    Phoenix, Arizona, 85029

  • Braintree Research Site 59

    Sacramento, California, 95821

  • Braintree Research Site 28

    Sacramento, California, 95842

  • Braintree Research Site 35

    Salt Lake City, Utah, 84107

  • Braintree Research Site 24

    Spartanburg, South Carolina, 29303

  • Braintree Research Site 72

    Spartanburg, South Carolina, 29307

  • Braintree Research Site 49

    St Louis, Missouri, 63042

  • Braintree Research Site 12

    St. George, Utah, 84790

  • Braintree Research Site 20

    St. Petersburg, Florida, 33709

  • Braintree Research Site 39

    St. Petersburg, Florida, 33709

  • Braintree Research Site 9

    Summerville, South Carolina, 29485

  • Braintree Research Site 6

    Tacoma, Washington, 98405

  • Braintree Research Site 31

    Tampa, Florida, 33634

  • Braintree Research Site 53

    Trenton, New Jersey, 08611

  • Braintree Research Site 67

    Tullahoma, Tennessee, 37388

  • Braintree Research Site 66

    West Jordan, Utah, 84088

  • Braintree Research Site 41

    West Palm Beach, Florida, 33409

  • Braintree Research Site 38

    Wichita, Kansas, 67203

  • Braintree Research Site 61

    Williamsville, New York, 14221

  • Braintree Research Site 47

    Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

The objective of this study is to evaluate multiple doses of BLI801 Laxative for safety and efficacy versus placebo in adults experiencing non-idiopathic constipation.

Conditions
Constipation
Being tested
BLI801 Laxative, BLI801 Placebo
Medical subject headings
Constipation

What participants receive

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

  • BLI801 LaxativeDrug

    BLI801 oral laxative

  • BLI801 PlaceboDrug

    BLI801 oral laxative placebo

Study groups in NCT02822508
Study groupRoleWhat they receive
BLI801 Laxative (high dose)ExperimentalBLI801 Laxative (high dose)
Receives: Drug: BLI801 Laxative
BLI801 Laxative (mid dose)ExperimentalBLI801 Laxative (mid dose)
Receives: Drug: BLI801 Laxative
BLI801 Laxative (low dose)ExperimentalBLI801 Laxative (low dose)
Receives: Drug: BLI801 Laxative
BLI801 PlaceboPlacebo comparatorBLI801 Placebo
Receives: Drug: BLI801 Placebo

What is being measured

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

  1. % of Subjects With Treatment Response

    Treatment response is defined as 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 spontaneous bowel movements (SBMs) and an increase from baseline of > 1 SBM 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.

  1. First posted4 Jul 2016 (estimated)
  2. Study startJun 2016
  3. Primary completionApr 2017
  4. Study completionApr 2017

Resources

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
434 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02822508
Sponsor's protocol ID
BLI801-203
Status last verified
Oct 2023
First submitted
30 Jun 2016
Last updated
7 Nov 2023
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing BLI801 Laxative in people with Constipation, run by Braintree Laboratories at 73 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 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 73 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 combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 7 Nov 2023). 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?

% of Subjects With 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 NCT02822508.

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 7 Nov 2023.

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