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Completed

NCT Number: NCT02270983

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

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.

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Key information

Conditions

Opioid-induced Constipation Chemically-Induced Disorders Constipation Mental Disorders Narcotic-Related Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Forest Investigative Site 002, Anniston, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Linaclotide 145 micrograms

Drug

Other names: Linzess

Linaclotide 290 micrograms

Drug

Other names: Linzess

Placebo

Drug

Matching placebo

Primary outcomes

  1. 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

  1. 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

  2. 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.

  3. 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:

    • = 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)

  4. 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."

  5. 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.

Sponsors and collaborators

Lead sponsor

Forest Laboratories

Industry

Collaborators

  • Ironwood Pharmaceuticals, Inc.

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Oct 22, 2014
Registry last updated
Apr 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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