Current partner codePEPTIDESDE
NCT02270983·Phase 2·INTERVENTIONAL

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

Status

Completed

Phase

Phase 2

Enrollment

254

Locations

77

Results

Posted

Publications

1

Study summary

What the protocol is testing.

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.

Interventions

Treatment arms and agents.

DRUG

Linaclotide 145 micrograms

DRUG

Linaclotide 290 micrograms

DRUG

Placebo

Matching placebo

Timeline

From registration to results.

  1. First posted

    Oct 22, 2014

  2. Study start

    Oct 31, 2014

  3. Primary completion

    Aug 31, 2015

  4. Study completion

    Oct 31, 2015

  5. Results posted

    Apr 8, 2019

  6. Registry updated

    Apr 8, 2019

Outcomes

What the study measures.

Primary outcomes

Change From Baseline in 8-Week SBM Frequency Rate (SBMs/Week)

Time frame · Baseline (Week 0) to Week 8

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

Secondary outcomes

Time to First SBM After the First Dose of Investigational Product

Time frame · Baseline (Day 0) up to 8 weeks

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

Time frame · 8-week treatment period

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

Time frame · Baseline (Week 0) to Week 8

Stool Consistency was assessed using the 7-Point Bristol Stool Form Scale: 1. = separate hard lumps like nuts (difficult to pass) 2. = sausage shaped but lumpy 3. = like a sausage but with cracks on surface 4. = like a sausage or snake, smooth and soft 5. = soft blobs with clear-cut edges (passed easily) 6. = fluffy pieces with ragged edges, a mushy 7. = watery, no solid pieces (entirely liquid)

Change From Baseline in 8-Week Straining

Time frame · Baseline (Week 0) to Week 8

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

Time frame · Baseline (Week 0) to Week 8

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.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

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 locations

77 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

Forest Investigative Site 002

Anniston, Alabama, United States

Forest Investigative Site 001

Foley, Alabama, United States

Forest Investigative Site 007

Phoenix, Arizona, United States

Forest Investigative Site 008

Tucson, Arizona, United States

Forest Investigative Site 003

North Little Rock, Arkansas, United States

Forest Investigative Site 018

Anaheim, California, United States

Forest Investigative Site 014

Fountain Valley, California, United States

Forest Investigative Site 019

Fresno, California, United States

Forest Investigative Site 017

Garden Grove, California, United States

Forest Investigative Site 010

Gold River, California, United States

Forest Investigative Site 009

Lincoln, California, United States

Forest Investigative Site 012

North Hollywood, California, United States

Forest Investigative Site 011

Orange, California, United States

Forest Investigative Site 016

Sacramento, California, United States

Forest Investigative Site 013

San Diego, California, United States

Forest Investigative Site 015

Santa Ana, California, United States

Forest Investigative Site 020

Colorado Springs, Colorado, United States

Forest Investigative Site 021

Bristol, Connecticut, United States

Forest Investigative Site 035

Boynton Beach, Florida, United States

Forest Investigative Site 038

Bradenton, Florida, United States

Forest Investigative Site 024

DeLand, Florida, United States

Forest Investigative Site 027

Gainesville, Florida, United States

Forest Investigative Site 023

Jacksonville, Florida, United States

Forest Investigative Site 036

Jupiter, Florida, United States

Related trials

More studies on Linaclotide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.