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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02270983
Other study ID # LIN-MD-40
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date October 31, 2014
Est. completion date October 31, 2015

Study information

Verified date April 2019
Source Forest Laboratories
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 254
Est. completion date October 31, 2015
Est. primary completion date August 31, 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Linaclotide 145 micrograms

Linaclotide 290 micrograms

Placebo
Matching placebo

Locations

Country Name City State
United States Forest Investigative Site 018 Anaheim California
United States Forest Investigative Site 002 Anniston Alabama
United States Forest Investigative Site 082 Asheboro North Carolina
United States Forest Investigative Site 079 Bellevue Washington
United States Forest Investigative Site 035 Boynton Beach Florida
United States Forest Investigative Site 038 Bradenton Florida
United States Forest Investigative Site 021 Bristol Connecticut
United States Forest Investigative Site 054 Chapel Hill North Carolina
United States Forest Investigative Site 070 Charleston South Carolina
United States Forest Investigative Site 050 Chesterfield Michigan
United States Forest Investigative Site 043 Chicago Illinois
United States Forest Investigative Site 078 Christiansburg Virginia
United States Forest Investigative Site 062 Cincinnati Ohio
United States Forest Investigative Site 020 Colorado Springs Colorado
United States Forest Investigative Site 061 Columbus Ohio
United States Forest Investigative Site 068 Cumberland Rhode Island
United States Forest Investigative Site 088 Davidson North Carolina
United States Forest Investigative Site 024 DeLand Florida
United States Forest Investigative Site 044 Evansville Indiana
United States Forest Investigative Site 056 Fargo North Dakota
United States Forest Investigative Site 051 Flat Rock North Carolina
United States Forest Investigative Site 049 Flint Michigan
United States Forest Investigative Site 001 Foley Alabama
United States Forest Investigative Site 014 Fountain Valley California
United States Forest Investigative Site 019 Fresno California
United States Forest Investigative Site 027 Gainesville Florida
United States Forest Investigative Site 017 Garden Grove California
United States Forest Investigative Site 010 Gold River California
United States Forest Investigative Site 052 Greensboro North Carolina
United States Forest Investigative Site 055 Greensboro North Carolina
United States Forest Investigative Site 048 Hagerstown Maryland
United States Forest Investigative Site 023 Jacksonville Florida
United States Forest Investigative Site 036 Jupiter Florida
United States Forest Investigative Site 037 Lauderdale Lakes Florida
United States Forest Investigative Site 067 Levittown Pennsylvania
United States Forest Investigative Site 009 Lincoln California
United States Forest Investigative Site 075 Logan Utah
United States Forest Investigative Site 045 Madisonville Kentucky
United States Forest Investigative Site 041 Marietta Georgia
United States Forest Investigative Site 066 Medford Oregon
United States Forest Investigative Site 060 Mentor Ohio
United States Forest Investigative Site 046 Metairie Louisiana
United States Forest Investigative Site 028 Miami Florida
United States Forest Investigative Site 012 North Hollywood California
United States Forest Investigative Site 003 North Little Rock Arkansas
United States Forest Investigative Site 084 Ogden Utah
United States Forest Investigative Site 063 Oklahoma City Oklahoma
United States Forest Investigative Site 064 Oklahoma City Oklahoma
United States Forest Investigative Site 057 Omaha Nebraska
United States Forest Investigative Site 058 Omaha Nebraska
United States Forest Investigative Site 011 Orange California
United States Forest Investigative Site 040 Orlando Florida
United States Forest Investigative Site 022 Oviedo Florida
United States Forest Investigative Site 080 Philadelphia Pennsylvania
United States Forest Investigative Site 007 Phoenix Arizona
United States Forest Investigative Site 034 Port Orange Florida
United States Forest Investigative Site 083 Richardson Texas
United States Forest Investigative Site 016 Sacramento California
United States Forest Investigative Site 071 San Antonio Texas
United States Forest Investigative Site 073 San Antonio Texas
United States Forest Investigative Site 074 San Antonio Texas
United States Forest Investigative Site 013 San Diego California
United States Forest Investigative Site 015 Santa Ana California
United States Forest Investigative Site 029 Seminole Florida
United States Forest Investigative Site 030 Tampa Florida
United States Forest Investigative Site 031 Tampa Florida
United States Forest Investigative Site 033 Tampa Florida
United States Forest Investigative Site 008 Tucson Arizona
United States Forest Investigative Site 065 Tulsa Oklahoma
United States Forest Investigative Site 087 Wadsworth Ohio
United States Forest Investigative Site 047 Watertown Massachusetts
United States Forest Investigative Site 076 West Jordan Utah
United States Forest Investigative Site 039 West Palm Beach Florida
United States Forest Investigative Site 032 Weston Florida
United States Forest Investigative Site 059 Williamsville New York
United States Forest Investigative Site 053 Winston-Salem North Carolina
United States Forest Investigative Site 042 Woodstock Georgia

Sponsors (2)

Lead Sponsor Collaborator
Forest Laboratories Ironwood Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Baseline (Week 0) to Week 8
Secondary 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 Baseline (Day 0) up to 8 weeks
Secondary 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. 8-week treatment period
Secondary 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)
Baseline (Week 0) to Week 8
Secondary 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." Baseline (Week 0) to Week 8
Secondary 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. Baseline (Week 0) to Week 8
See also
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