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
Public ClinicalTrials.gov record NCT02270983. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02270983
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 254 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 31, 2014 (Actual)
- Primary completion
- Aug 31, 2015 (Actual)
- Completion
- Oct 31, 2015 (Actual)
- Last update posted
- Apr 8, 2019
2014 – 2015
United States locations
- U.S. sites
- 77
- U.S. states
- 29
- U.S. cities
- 70
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Forest Investigative Site 002 | Anniston | Alabama | 36207 | — |
| Forest Investigative Site 001 | Foley | Alabama | 36535 | — |
| Forest Investigative Site 007 | Phoenix | Arizona | 85029 | — |
| Forest Investigative Site 008 | Tucson | Arizona | 85710 | — |
| Forest Investigative Site 003 | North Little Rock | Arkansas | 72217 | — |
| Forest Investigative Site 018 | Anaheim | California | 92801 | — |
| Forest Investigative Site 014 | Fountain Valley | California | 92708 | — |
| Forest Investigative Site 019 | Fresno | California | 93702 | — |
| Forest Investigative Site 017 | Garden Grove | California | 92843 | — |
| Forest Investigative Site 010 | Gold River | California | 95670 | — |
| Forest Investigative Site 009 | Lincoln | California | 95648 | — |
| Forest Investigative Site 012 | North Hollywood | California | 91606 | — |
| Forest Investigative Site 011 | Orange | California | 92868 | — |
| Forest Investigative Site 016 | Sacramento | California | 95821 | — |
| Forest Investigative Site 013 | San Diego | California | 92108 | — |
| Forest Investigative Site 015 | Santa Ana | California | 92701 | — |
| Forest Investigative Site 020 | Colorado Springs | Colorado | 80904 | — |
| Forest Investigative Site 021 | Bristol | Connecticut | 06010 | — |
| Forest Investigative Site 035 | Boynton Beach | Florida | 33426 | — |
| Forest Investigative Site 038 | Bradenton | Florida | 34208 | — |
| Forest Investigative Site 024 | DeLand | Florida | 32720 | — |
| Forest Investigative Site 027 | Gainesville | Florida | 32607 | — |
| Forest Investigative Site 023 | Jacksonville | Florida | 32257 | — |
| Forest Investigative Site 036 | Jupiter | Florida | 33458 | — |
| Forest Investigative Site 037 | Lauderdale Lakes | Florida | 33319 | — |
| Forest Investigative Site 028 | Miami | Florida | 33185 | — |
| Forest Investigative Site 040 | Orlando | Florida | 32801 | — |
| Forest Investigative Site 022 | Oviedo | Florida | 32765 | — |
| Forest Investigative Site 034 | Port Orange | Florida | 32129 | — |
| Forest Investigative Site 029 | Seminole | Florida | 33777 | — |
| Forest Investigative Site 031 | Tampa | Florida | 33603 | — |
| Forest Investigative Site 033 | Tampa | Florida | 33606 | — |
| Forest Investigative Site 030 | Tampa | Florida | 33613 | — |
| Forest Investigative Site 039 | West Palm Beach | Florida | 33409 | — |
| Forest Investigative Site 032 | Weston | Florida | 33331 | — |
| Forest Investigative Site 041 | Marietta | Georgia | 30060 | — |
| Forest Investigative Site 042 | Woodstock | Georgia | 30189 | — |
| Forest Investigative Site 043 | Chicago | Illinois | 60616 | — |
| Forest Investigative Site 044 | Evansville | Indiana | 47714 | — |
| Forest Investigative Site 045 | Madisonville | Kentucky | 42431 | — |
| Forest Investigative Site 046 | Metairie | Louisiana | 70006 | — |
| Forest Investigative Site 048 | Hagerstown | Maryland | 21742 | — |
| Forest Investigative Site 047 | Watertown | Massachusetts | 02472 | — |
| Forest Investigative Site 050 | Chesterfield | Michigan | 48047 | — |
| Forest Investigative Site 049 | Flint | Michigan | 48504 | — |
| Forest Investigative Site 058 | Omaha | Nebraska | 68114 | — |
| Forest Investigative Site 057 | Omaha | Nebraska | 68134 | — |
| Forest Investigative Site 059 | Williamsville | New York | 14221 | — |
| Forest Investigative Site 082 | Asheboro | North Carolina | 27203 | — |
| Forest Investigative Site 054 | Chapel Hill | North Carolina | 27514 | — |
| Forest Investigative Site 088 | Davidson | North Carolina | 28036 | — |
| Forest Investigative Site 051 | Flat Rock | North Carolina | 28731 | — |
| Forest Investigative Site 052 | Greensboro | North Carolina | 27403 | — |
| Forest Investigative Site 055 | Greensboro | North Carolina | 27410 | — |
| Forest Investigative Site 053 | Winston-Salem | North Carolina | 27103 | — |
| Forest Investigative Site 056 | Fargo | North Dakota | 58103 | — |
| Forest Investigative Site 062 | Cincinnati | Ohio | 45219 | — |
| Forest Investigative Site 061 | Columbus | Ohio | 43213 | — |
| Forest Investigative Site 060 | Mentor | Ohio | 44060 | — |
| Forest Investigative Site 087 | Wadsworth | Ohio | 44281 | — |
| Forest Investigative Site 064 | Oklahoma City | Oklahoma | 73103 | — |
| Forest Investigative Site 063 | Oklahoma City | Oklahoma | 73120 | — |
| Forest Investigative Site 065 | Tulsa | Oklahoma | 74104 | — |
| Forest Investigative Site 066 | Medford | Oregon | 97504 | — |
| Forest Investigative Site 067 | Levittown | Pennsylvania | 19056 | — |
| Forest Investigative Site 080 | Philadelphia | Pennsylvania | 19140 | — |
| Forest Investigative Site 068 | Cumberland | Rhode Island | 02864 | — |
| Forest Investigative Site 070 | Charleston | South Carolina | 29406 | — |
| Forest Investigative Site 083 | Richardson | Texas | 75080 | — |
| Forest Investigative Site 074 | San Antonio | Texas | 78209 | — |
| Forest Investigative Site 073 | San Antonio | Texas | 78215 | — |
| Forest Investigative Site 071 | San Antonio | Texas | 78229 | — |
| Forest Investigative Site 075 | Logan | Utah | 84341 | — |
| Forest Investigative Site 084 | Ogden | Utah | 84341 | — |
| Forest Investigative Site 076 | West Jordan | Utah | 84088 | — |
| Forest Investigative Site 078 | Christiansburg | Virginia | 24073 | — |
| Forest Investigative Site 079 | Bellevue | Washington | 98007 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02270983, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 8, 2019 · Synced Oct 22, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02270983 live on ClinicalTrials.gov.