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Phase 2 Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial of Linaclotide Administered to Patients With Opioid-Induced Constipation Receiving Chronic Opioid Treatment for Non-Cancer Pain

Primary Purpose

Opioid-Induced Constipation

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Linaclotide 145 micrograms
Linaclotide 290 micrograms
Placebo
Sponsored by
Forest Laboratories
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Opioid-Induced Constipation focused on measuring Opioid-Induced Constipation, Linaclotide, Linzess

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patient has chronic non-cancer pain that has been present for a minimum of 3 months
  • Patient has been receiving a stable oral dose of a full-opioid agonist for at least 4 days per week during the 8 consecutive weeks

  • Patient meets protocol criteria for Opioid-Induced Constipation (OIC): < 3 spontaneous bowel movements (SBMs) per week and reports one of the following symptoms for at least 4 weeks:

    1. Straining during > 25% of BMs
    2. Lumpy or hard stools during > 25% of BMs
    3. Sensation of incomplete evacuation during > 25% of BMs
  • Patient meets the colonoscopy requirements defined by the American Gastroenterological Association guidelines
  • Patient has successfully completed protocol procedures (with no clinically significant findings)
  • Patient is compliant with Interactive Voice Response System (IVRS) for daily diary reporting
  • Patient has a total of < 6 SBMs in IVRS during the 14 days before and up to the time of Randomization
  • Patient has adequate relief and well-controlled pain with current dose of opioid

Exclusion Criteria:

  • Patient has been using opioids for abdominal pain
  • Patient has symptoms of or been diagnosed with chronic constipation or chronic idiopathic constipation prior to initiation of opioid treatment
  • Patient has symptoms of or been diagnosed with Irritable Bowel Syndrome (IBS) prior to initiation of opioid treatment
  • Patient has a history of loose or watery stools for > 25% of BMs during the 3 months before the Screening in the absence of laxatives, suppositories, or enemas
  • Patient has a structural abnormality of the gastrointestinal (GI) tract or a disease or condition that can affect GI motility
  • Patient has any protocol-excluded or clinically significant medical or surgical history that would limit the patient's ability to complete or participate in this clinical trial or could confound the study assessments

Sites / Locations

  • Forest Investigative Site 002
  • Forest Investigative Site 001
  • Forest Investigative Site 007
  • Forest Investigative Site 008
  • Forest Investigative Site 003
  • Forest Investigative Site 018
  • Forest Investigative Site 014
  • Forest Investigative Site 019
  • Forest Investigative Site 017
  • Forest Investigative Site 010
  • Forest Investigative Site 009
  • Forest Investigative Site 012
  • Forest Investigative Site 011
  • Forest Investigative Site 016
  • Forest Investigative Site 013
  • Forest Investigative Site 015
  • Forest Investigative Site 020
  • Forest Investigative Site 021
  • Forest Investigative Site 035
  • Forest Investigative Site 038
  • Forest Investigative Site 024
  • Forest Investigative Site 027
  • Forest Investigative Site 023
  • Forest Investigative Site 036
  • Forest Investigative Site 037
  • Forest Investigative Site 028
  • Forest Investigative Site 040
  • Forest Investigative Site 022
  • Forest Investigative Site 034
  • Forest Investigative Site 029
  • Forest Investigative Site 031
  • Forest Investigative Site 033
  • Forest Investigative Site 030
  • Forest Investigative Site 039
  • Forest Investigative Site 032
  • Forest Investigative Site 041
  • Forest Investigative Site 042
  • Forest Investigative Site 043
  • Forest Investigative Site 044
  • Forest Investigative Site 045
  • Forest Investigative Site 046
  • Forest Investigative Site 048
  • Forest Investigative Site 047
  • Forest Investigative Site 050
  • Forest Investigative Site 049
  • Forest Investigative Site 058
  • Forest Investigative Site 057
  • Forest Investigative Site 059
  • Forest Investigative Site 082
  • Forest Investigative Site 054
  • Forest Investigative Site 088
  • Forest Investigative Site 051
  • Forest Investigative Site 052
  • Forest Investigative Site 055
  • Forest Investigative Site 053
  • Forest Investigative Site 056
  • Forest Investigative Site 062
  • Forest Investigative Site 061
  • Forest Investigative Site 060
  • Forest Investigative Site 087
  • Forest Investigative Site 064
  • Forest Investigative Site 063
  • Forest Investigative Site 065
  • Forest Investigative Site 066
  • Forest Investigative Site 067
  • Forest Investigative Site 080
  • Forest Investigative Site 068
  • Forest Investigative Site 070
  • Forest Investigative Site 083
  • Forest Investigative Site 074
  • Forest Investigative Site 073
  • Forest Investigative Site 071
  • Forest Investigative Site 075
  • Forest Investigative Site 084
  • Forest Investigative Site 076
  • Forest Investigative Site 078
  • Forest Investigative Site 079

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Linaclotide 145 micrograms

Linaclotide 290 micrograms

Placebo

Arm Description

Oral capsule, taken once daily each morning at least 30 minutes before breakfast, with the exception of the first Treatment Period dose which will be taken at the study center after at least a 2-hour fast.

Oral capsule, taken once daily each morning at least 30 minutes before breakfast, with the exception of the first Treatment Period dose which will be taken at the study center after at least a 2-hour fast.

Oral capsule, taken once daily each morning at least 30 minutes before breakfast, with the exception of the first Treatment Period dose which will be taken at the study center after at least a 2-hour fast.

Outcomes

Primary Outcome Measures

Change From Baseline in 8-Week SBM Frequency Rate (SBMs/Week)
Change from baseline in 8-Week SBM frequency rate (SBMs/week) during the Treatment Period.

Secondary Outcome Measures

Time to First SBM After the First Dose of Investigational Product
The median time to the first SBM after the first dose of investigational product
Percentage of Participants Meeting 6/8 Week Spontaneous Bowel Movement (SBM) 3 + 1 Responder Criteria
A 6/8 Week SBM 3 + 1 responder was a participant who met the weekly SBM 3 + 1 responder criteria for at least 6 out of the 8 weeks of the Treatment Period. For each week in the Treatment Period, a weekly SBM 3 + 1 responder was a patient who had an SBM weekly rate ≥ 3 and an increase ≥ 1 in the SBM weekly rate from baseline for that week.
Change From Baseline in 8-Week Stool Consistency
Stool Consistency was assessed using the 7-Point Bristol Stool Form Scale: = separate hard lumps like nuts (difficult to pass) = sausage shaped but lumpy = like a sausage but with cracks on surface = like a sausage or snake, smooth and soft = soft blobs with clear-cut edges (passed easily) = fluffy pieces with ragged edges, a mushy = watery, no solid pieces (entirely liquid)
Change From Baseline in 8-Week Straining
Straining was measured on a 5-point ordinal scale where a value of 1 is "not at all" and a value of 5 is "an extreme amount."
Change From Baseline in 8-Week Abdominal Bloating
Abdominal bloating was collected daily via IVRS calls and measured using an 11-point numerical rating scale, where 0 represents no abdominal bloating and 10 represents very severe abdominal bloating.

Full Information

First Posted
October 16, 2014
Last Updated
April 4, 2019
Sponsor
Forest Laboratories
Collaborators
Ironwood Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02270983
Brief Title
Phase 2 Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial of Linaclotide Administered to Patients With Opioid-Induced Constipation Receiving Chronic Opioid Treatment for Non-Cancer Pain
Official Title
A Phase 2 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial of Linaclotide Administered Orally for 8 Weeks to Adult Outpatients With Opioid-Induced Constipation Receiving Chronic Opioid Treatment for Non-Cancer Pain
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
October 31, 2014 (Actual)
Primary Completion Date
August 31, 2015 (Actual)
Study Completion Date
October 31, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Forest Laboratories
Collaborators
Ironwood Pharmaceuticals, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study was to evaluate the safety and efficacy of linaclotide for the treatment of opioid-induced constipation (OIC), in adults receiving stable opioid treatment for chronic non-cancer pain that has been present for a minimum of 3 months. This study included up to a 4-week Screening Period, and a 2 to 3-week Pretreatment Period. Patients meeting the entry criteria were randomized to 1 of 2 doses of linaclotide or placebo once per day for 8 weeks. This 8-week study assessed the effects of linaclotide on bowel movement frequency, as well as other bowel symptoms of OIC.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid-Induced Constipation
Keywords
Opioid-Induced Constipation, Linaclotide, Linzess

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
254 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Linaclotide 145 micrograms
Arm Type
Experimental
Arm Description
Oral capsule, taken once daily each morning at least 30 minutes before breakfast, with the exception of the first Treatment Period dose which will be taken at the study center after at least a 2-hour fast.
Arm Title
Linaclotide 290 micrograms
Arm Type
Experimental
Arm Description
Oral capsule, taken once daily each morning at least 30 minutes before breakfast, with the exception of the first Treatment Period dose which will be taken at the study center after at least a 2-hour fast.
Arm Title
Placebo
Arm Type
Experimental
Arm Description
Oral capsule, taken once daily each morning at least 30 minutes before breakfast, with the exception of the first Treatment Period dose which will be taken at the study center after at least a 2-hour fast.
Intervention Type
Drug
Intervention Name(s)
Linaclotide 145 micrograms
Other Intervention Name(s)
Linzess
Intervention Type
Drug
Intervention Name(s)
Linaclotide 290 micrograms
Other Intervention Name(s)
Linzess
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo
Primary Outcome Measure Information:
Title
Change From Baseline in 8-Week SBM Frequency Rate (SBMs/Week)
Description
Change from baseline in 8-Week SBM frequency rate (SBMs/week) during the Treatment Period.
Time Frame
Baseline (Week 0) to Week 8
Secondary Outcome Measure Information:
Title
Time to First SBM After the First Dose of Investigational Product
Description
The median time to the first SBM after the first dose of investigational product
Time Frame
Baseline (Day 0) up to 8 weeks
Title
Percentage of Participants Meeting 6/8 Week Spontaneous Bowel Movement (SBM) 3 + 1 Responder Criteria
Description
A 6/8 Week SBM 3 + 1 responder was a participant who met the weekly SBM 3 + 1 responder criteria for at least 6 out of the 8 weeks of the Treatment Period. For each week in the Treatment Period, a weekly SBM 3 + 1 responder was a patient who had an SBM weekly rate ≥ 3 and an increase ≥ 1 in the SBM weekly rate from baseline for that week.
Time Frame
8-week treatment period
Title
Change From Baseline in 8-Week Stool Consistency
Description
Stool Consistency was assessed using the 7-Point Bristol Stool Form Scale: = separate hard lumps like nuts (difficult to pass) = sausage shaped but lumpy = like a sausage but with cracks on surface = like a sausage or snake, smooth and soft = soft blobs with clear-cut edges (passed easily) = fluffy pieces with ragged edges, a mushy = watery, no solid pieces (entirely liquid)
Time Frame
Baseline (Week 0) to Week 8
Title
Change From Baseline in 8-Week Straining
Description
Straining was measured on a 5-point ordinal scale where a value of 1 is "not at all" and a value of 5 is "an extreme amount."
Time Frame
Baseline (Week 0) to Week 8
Title
Change From Baseline in 8-Week Abdominal Bloating
Description
Abdominal bloating was collected daily via IVRS calls and measured using an 11-point numerical rating scale, where 0 represents no abdominal bloating and 10 represents very severe abdominal bloating.
Time Frame
Baseline (Week 0) to Week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient has chronic non-cancer pain that has been present for a minimum of 3 months Patient has been receiving a stable oral dose of a full-opioid agonist for at least 4 days per week during the 8 consecutive weeks Patient meets protocol criteria for Opioid-Induced Constipation (OIC): < 3 spontaneous bowel movements (SBMs) per week and reports one of the following symptoms for at least 4 weeks: Straining during > 25% of BMs Lumpy or hard stools during > 25% of BMs Sensation of incomplete evacuation during > 25% of BMs Patient meets the colonoscopy requirements defined by the American Gastroenterological Association guidelines Patient has successfully completed protocol procedures (with no clinically significant findings) Patient is compliant with Interactive Voice Response System (IVRS) for daily diary reporting Patient has a total of < 6 SBMs in IVRS during the 14 days before and up to the time of Randomization Patient has adequate relief and well-controlled pain with current dose of opioid Exclusion Criteria: Patient has been using opioids for abdominal pain Patient has symptoms of or been diagnosed with chronic constipation or chronic idiopathic constipation prior to initiation of opioid treatment Patient has symptoms of or been diagnosed with Irritable Bowel Syndrome (IBS) prior to initiation of opioid treatment Patient has a history of loose or watery stools for > 25% of BMs during the 3 months before the Screening in the absence of laxatives, suppositories, or enemas Patient has a structural abnormality of the gastrointestinal (GI) tract or a disease or condition that can affect GI motility Patient has any protocol-excluded or clinically significant medical or surgical history that would limit the patient's ability to complete or participate in this clinical trial or could confound the study assessments
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patricia D'Astoli, RN
Organizational Affiliation
Forest Laboratories, LLC, an Allergan Affiliate
Official's Role
Study Director
Facility Information:
Facility Name
Forest Investigative Site 002
City
Anniston
State/Province
Alabama
ZIP/Postal Code
36207
Country
United States
Facility Name
Forest Investigative Site 001
City
Foley
State/Province
Alabama
ZIP/Postal Code
36535
Country
United States
Facility Name
Forest Investigative Site 007
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85029
Country
United States
Facility Name
Forest Investigative Site 008
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85710
Country
United States
Facility Name
Forest Investigative Site 003
City
North Little Rock
State/Province
Arkansas
ZIP/Postal Code
72217
Country
United States
Facility Name
Forest Investigative Site 018
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Forest Investigative Site 014
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
Forest Investigative Site 019
City
Fresno
State/Province
California
ZIP/Postal Code
93702
Country
United States
Facility Name
Forest Investigative Site 017
City
Garden Grove
State/Province
California
ZIP/Postal Code
92843
Country
United States
Facility Name
Forest Investigative Site 010
City
Gold River
State/Province
California
ZIP/Postal Code
95670
Country
United States
Facility Name
Forest Investigative Site 009
City
Lincoln
State/Province
California
ZIP/Postal Code
95648
Country
United States
Facility Name
Forest Investigative Site 012
City
North Hollywood
State/Province
California
ZIP/Postal Code
91606
Country
United States
Facility Name
Forest Investigative Site 011
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Forest Investigative Site 016
City
Sacramento
State/Province
California
ZIP/Postal Code
95821
Country
United States
Facility Name
Forest Investigative Site 013
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
Forest Investigative Site 015
City
Santa Ana
State/Province
California
ZIP/Postal Code
92701
Country
United States
Facility Name
Forest Investigative Site 020
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80904
Country
United States
Facility Name
Forest Investigative Site 021
City
Bristol
State/Province
Connecticut
ZIP/Postal Code
06010
Country
United States
Facility Name
Forest Investigative Site 035
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33426
Country
United States
Facility Name
Forest Investigative Site 038
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34208
Country
United States
Facility Name
Forest Investigative Site 024
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
Forest Investigative Site 027
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32607
Country
United States
Facility Name
Forest Investigative Site 023
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32257
Country
United States
Facility Name
Forest Investigative Site 036
City
Jupiter
State/Province
Florida
ZIP/Postal Code
33458
Country
United States
Facility Name
Forest Investigative Site 037
City
Lauderdale Lakes
State/Province
Florida
ZIP/Postal Code
33319
Country
United States
Facility Name
Forest Investigative Site 028
City
Miami
State/Province
Florida
ZIP/Postal Code
33185
Country
United States
Facility Name
Forest Investigative Site 040
City
Orlando
State/Province
Florida
ZIP/Postal Code
32801
Country
United States
Facility Name
Forest Investigative Site 022
City
Oviedo
State/Province
Florida
ZIP/Postal Code
32765
Country
United States
Facility Name
Forest Investigative Site 034
City
Port Orange
State/Province
Florida
ZIP/Postal Code
32129
Country
United States
Facility Name
Forest Investigative Site 029
City
Seminole
State/Province
Florida
ZIP/Postal Code
33777
Country
United States
Facility Name
Forest Investigative Site 031
City
Tampa
State/Province
Florida
ZIP/Postal Code
33603
Country
United States
Facility Name
Forest Investigative Site 033
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Forest Investigative Site 030
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Forest Investigative Site 039
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33409
Country
United States
Facility Name
Forest Investigative Site 032
City
Weston
State/Province
Florida
ZIP/Postal Code
33331
Country
United States
Facility Name
Forest Investigative Site 041
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Forest Investigative Site 042
City
Woodstock
State/Province
Georgia
ZIP/Postal Code
30189
Country
United States
Facility Name
Forest Investigative Site 043
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60616
Country
United States
Facility Name
Forest Investigative Site 044
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
Facility Name
Forest Investigative Site 045
City
Madisonville
State/Province
Kentucky
ZIP/Postal Code
42431
Country
United States
Facility Name
Forest Investigative Site 046
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Forest Investigative Site 048
City
Hagerstown
State/Province
Maryland
ZIP/Postal Code
21742
Country
United States
Facility Name
Forest Investigative Site 047
City
Watertown
State/Province
Massachusetts
ZIP/Postal Code
02472
Country
United States
Facility Name
Forest Investigative Site 050
City
Chesterfield
State/Province
Michigan
ZIP/Postal Code
48047
Country
United States
Facility Name
Forest Investigative Site 049
City
Flint
State/Province
Michigan
ZIP/Postal Code
48504
Country
United States
Facility Name
Forest Investigative Site 058
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Forest Investigative Site 057
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68134
Country
United States
Facility Name
Forest Investigative Site 059
City
Williamsville
State/Province
New York
ZIP/Postal Code
14221
Country
United States
Facility Name
Forest Investigative Site 082
City
Asheboro
State/Province
North Carolina
ZIP/Postal Code
27203
Country
United States
Facility Name
Forest Investigative Site 054
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Facility Name
Forest Investigative Site 088
City
Davidson
State/Province
North Carolina
ZIP/Postal Code
28036
Country
United States
Facility Name
Forest Investigative Site 051
City
Flat Rock
State/Province
North Carolina
ZIP/Postal Code
28731
Country
United States
Facility Name
Forest Investigative Site 052
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27403
Country
United States
Facility Name
Forest Investigative Site 055
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27410
Country
United States
Facility Name
Forest Investigative Site 053
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Forest Investigative Site 056
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58103
Country
United States
Facility Name
Forest Investigative Site 062
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Forest Investigative Site 061
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States
Facility Name
Forest Investigative Site 060
City
Mentor
State/Province
Ohio
ZIP/Postal Code
44060
Country
United States
Facility Name
Forest Investigative Site 087
City
Wadsworth
State/Province
Ohio
ZIP/Postal Code
44281
Country
United States
Facility Name
Forest Investigative Site 064
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
Facility Name
Forest Investigative Site 063
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73120
Country
United States
Facility Name
Forest Investigative Site 065
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Facility Name
Forest Investigative Site 066
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
Forest Investigative Site 067
City
Levittown
State/Province
Pennsylvania
ZIP/Postal Code
19056
Country
United States
Facility Name
Forest Investigative Site 080
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Facility Name
Forest Investigative Site 068
City
Cumberland
State/Province
Rhode Island
ZIP/Postal Code
02864
Country
United States
Facility Name
Forest Investigative Site 070
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
Facility Name
Forest Investigative Site 083
City
Richardson
State/Province
Texas
ZIP/Postal Code
75080
Country
United States
Facility Name
Forest Investigative Site 074
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78209
Country
United States
Facility Name
Forest Investigative Site 073
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
Forest Investigative Site 071
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Forest Investigative Site 075
City
Logan
State/Province
Utah
ZIP/Postal Code
84341
Country
United States
Facility Name
Forest Investigative Site 084
City
Ogden
State/Province
Utah
ZIP/Postal Code
84341
Country
United States
Facility Name
Forest Investigative Site 076
City
West Jordan
State/Province
Utah
ZIP/Postal Code
84088
Country
United States
Facility Name
Forest Investigative Site 078
City
Christiansburg
State/Province
Virginia
ZIP/Postal Code
24073
Country
United States
Facility Name
Forest Investigative Site 079
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98007
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
32310620
Citation
Brenner DM, Argoff CE, Fox SM, Bochenek W, D'Astoli P, Blakesley RE, Reasner DS, O'Dea CR, Cash BD. Efficacy and safety of linaclotide for opioid-induced constipation in patients with chronic noncancer pain syndromes from a phase 2 randomized study. Pain. 2020 May;161(5):1027-1036. doi: 10.1097/j.pain.0000000000001754.
Results Reference
derived

Learn more about this trial

Phase 2 Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial of Linaclotide Administered to Patients With Opioid-Induced Constipation Receiving Chronic Opioid Treatment for Non-Cancer Pain

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