Clincosm LogoSign in Get a demo

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

Sponsor
Braintree Laboratories (Industry)
Overall Status
Completed
CT.gov ID
NCT02822508
Collaborator
(none)
435
Enrollment
73
Locations
4
Arms
10
Duration (Months)
6
Patients Per Site
0.6
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: BLI801 Laxative
  • Drug: BLI801 Placebo
 Phase 2/Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
435 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Safety and Efficacy Evaluation of BLI801 Laxative in Adults Experiencing Non-Idiopathic Constipation
Study Start Date :
Jun 1, 2016
Actual Primary Completion Date :
Apr 1, 2017
Actual Study Completion Date :
Apr 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: BLI801 Laxative (high dose)

BLI801 Laxative (high dose)

Drug: BLI801 Laxative
BLI801 oral laxative
Experimental: BLI801 Laxative (mid dose)

BLI801 Laxative (mid dose)

Drug: BLI801 Laxative
BLI801 oral laxative
Experimental: BLI801 Laxative (low dose)

BLI801 Laxative (low dose)

Drug: BLI801 Laxative
BLI801 oral laxative
Placebo Comparator: BLI801 Placebo

BLI801 Placebo

Drug: BLI801 Placebo
BLI801 oral laxative placebo

Outcome Measures

Primary Outcome Measures

  1. % of subjects with treatment response [12 weeks]

    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.

Secondary Outcome Measures

  1. % of subjects with treatment emergent adverse events [12 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 84 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  1. Male or female subjects between the ages of > 18 and < 85 years

  2. 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

  1. Receiving a stable maintenance opioid regimen.

  2. If female, and of child-bearing potential, is using an acceptable form of birth control

  3. Negative pregnancy test at screening (Visit 1), if applicable

  4. In the Investigator's judgment, subject is mentally competent to provide informed consent to participate in the study

Exclusion Criteria:

  1. Subjects with known or suspected ileus, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis or toxic megacolon

  2. 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

  3. 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:

  4. Absence of a structural or biochemical explanation for the abdominal pain symptom

  5. At least 12 weeks during a period of 12 months, of abdominal discomfort or pain with at least 2 of the following 3 features:

  1. 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.

  1. Subjects diagnosed with chronic constipation prior to initiation of opioid treatment

  2. 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

  3. Subjects who are pregnant or nursing, or intend to become pregnant during the study

  4. Subjects of childbearing potential who refuse a pregnancy test

  5. Subjects who are allergic to any BLI801 component

  6. Subjects taking non-opioid medications or supplements known to cause constipation

  7. Subjects with an active history of drug or alcohol abuse

  8. Subjects who have participated in an investigational clinical, surgical, drug, or device study within the past 30 days

  9. Subjects who, in the opinion of the Investigator, should not be included in the study for any reason, including inability to follow study procedures.

  10. 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.

  11. Subjects who withdraw consent at any time prior to completion of Visit 1 procedures

Contacts and Locations

Locations

Site City State Country Postal Code
1 Braintree Research Site 43 Birmingham Alabama United States 35209
2 Braintree Research Site 30 Peoria Arizona United States 85381
3 Braintree Research Site 40 Phoenix Arizona United States 85018
4 Braintree Research Site 52 Phoenix Arizona United States 85020
5 Braintree Research Site 26 Phoenix Arizona United States 85029
6 Braintree Research Site 56 Fayetteville Arkansas United States 72703
7 Braintree Research Site 4 Little Rock Arkansas United States 72211
8 Braintree Research Site 51 Anaheim California United States 92801
9 Braintree Research Site 54 Fountain Valley California United States 92708
10 Braintree Research Site 8 Fresno California United States 93710
11 Braintree Research Site 71 Long Beach California United States 90806
12 Braintree Research Site 74 Oceanside California United States 92056
13 Braintree Research Site 59 Sacramento California United States 95821
14 Braintree Research Site 28 Sacramento California United States 95842
15 Braintree Research Site 68 Brooksville Florida United States 34601
16 Braintree Research Site 36 Fort Myers Florida United States 33912
17 Braintree Research Site 22 Homestead Florida United States 33030
18 Braintree Research Site 5 Jacksonville Florida United States 32218
19 Braintree Research Site 23 Jacksonville Florida United States 32257
20 Braintree Research Site 63 Miami Florida United States 33186
21 Braintree Research Site 29 Orlando Florida United States 32801
22 Braintree Research Site 65 Orlando Florida United States 32806
23 Braintree Research Site 13 Ormond Beach Florida United States 32174
24 Braintree Research Site 20 Saint Petersburg Florida United States 33709
25 Braintree Research Site 39 Saint Petersburg Florida United States 33709
26 Braintree Research Site 31 Tampa Florida United States 33634
27 Braintree Research Site 41 West Palm Beach Florida United States 33409
28 Braintree Research Site 57 Blue Ridge Georgia United States 30513
29 Braintree Research Site 48 Boise Idaho United States 83713
30 Braintree Research Site 50 Evansville Indiana United States 47714
31 Braintree Research Site 55 Lafayette Indiana United States 47905
32 Braintree Research Site 38 Wichita Kansas United States 67203
33 Braintree Research Site 64 Edgewood Kentucky United States 41017
34 Braintree Research Site 73 Lake Charles Louisiana United States 70601
35 Braintree Research Site 49 Saint Louis Missouri United States 63042
36 Braintree Research Site 19 Omaha Nebraska United States 68114
37 Braintree Research Site 21 Omaha Nebraska United States 68134
38 Braintree Research Site 69 Henderson Nevada United States 89014
39 Braintree Research Site 1 Las Vegas Nevada United States 89119
40 Braintree Research Site 44 Las Vegas Nevada United States 89119
41 Braintree Research Site 34 Las Vegas Nevada United States 89123
42 Braintree Research Site 7 Belvidere New Jersey United States 07823
43 Braintree Research Site 53 Trenton New Jersey United States 08611
44 Braintree Research Site 10 Albuquerque New Mexico United States 87102
45 Braintree Research Site 27 Brooklyn New York United States 11235
46 Braintree Research Site 25 Great Neck New York United States 11023
47 Braintree Research Site 61 Williamsville New York United States 14221
48 Braintree Research Site 45 Greensboro North Carolina United States 27410
49 Braintree Research Site 47 Winston-Salem North Carolina United States 27103
50 Braintree Research Site 2 Beavercreek Ohio United States 45432
51 Braintree Research Site 76 Cincinnati Ohio United States 45215
52 Braintree Research Site 3 Columbus Ohio United States 43213
53 Braintree Research Site 60 Columbus Ohio United States 43214
54 Braintree Research Site 14 Huber Heights Ohio United States 45424
55 Braintree Research Site 46 Oklahoma City Oklahoma United States 73109
56 Braintree Research Site 16 Oklahoma City Oklahoma United States 73119
57 Braintree Research Site 18 Lansdale Pennsylvania United States 19446
58 Braintree Research Site 75 Charleston South Carolina United States 29406
59 Braintree Research Site 17 Greer South Carolina United States 29651
60 Braintree Research Site 42 Myrtle Beach South Carolina United States 29588
61 Braintree Research Site 24 Spartanburg South Carolina United States 29303
62 Braintree Research Site 72 Spartanburg South Carolina United States 29307
63 Braintree Research Site 9 Summerville South Carolina United States 29485
64 Braintree Research Site 37 Chattanooga Tennessee United States 37421
65 Braintree Research Site 67 Tullahoma Tennessee United States 37388
66 Braintree Research Site 11 Austin Texas United States 78705
67 Braintree Research Site 33 Carrollton Texas United States 75007
68 Braintree Research Site 62 Channelview Texas United States 77530
69 Braintree Research Site 70 Houston Texas United States 77058
70 Braintree Research Site 12 Saint George Utah United States 84790
71 Braintree Research Site 35 Salt Lake City Utah United States 84107
72 Braintree Research Site 66 West Jordan Utah United States 84088
73 Braintree Research Site 6 Tacoma Washington United States 98405

Sponsors and Collaborators

  • Braintree Laboratories

Investigators

  • Study Director: John McGowan, Braintree Laboratories, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Braintree Laboratories
ClinicalTrials.gov Identifier:
NCT02822508
Other Study ID Numbers:
  • BLI801-203
First Posted:
Jul 4, 2016
Last Update Posted:
Jan 29, 2021
Last Verified:
Jan 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Additional relevant MeSH terms:
Constipation
Laxatives

Study Results

No Results Posted as of Jan 29, 2021