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Opioid-Induced ConstipationPhase 2NCT02270983

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

A Phase 2 study testing Linaclotide 145 micrograms and Linaclotide 290 micrograms in people with Opioid-Induced Constipation, run by Forest Laboratories at 77 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Opioid-Induced Constipation
What is being tested?
Linaclotide 145 micrograms and Linaclotide 290 micrograms
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
254 participants
Where
77 sitesUnited States
Study dates
31 Oct 2014to 31 Oct 2015
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 11Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

77 sites in 1 country.

77 sites in 1 country

United States77 sites

  • Forest Investigative Site 018

    Anaheim, California, 92801

  • Forest Investigative Site 002

    Anniston, Alabama, 36207

  • Forest Investigative Site 082

    Asheboro, North Carolina, 27203

  • Forest Investigative Site 079

    Bellevue, Washington, 98007

  • Forest Investigative Site 035

    Boynton Beach, Florida, 33426

  • Forest Investigative Site 038

    Bradenton, Florida, 34208

  • Forest Investigative Site 021

    Bristol, Connecticut, 06010

  • Forest Investigative Site 054

    Chapel Hill, North Carolina, 27514

  • Forest Investigative Site 070

    Charleston, South Carolina, 29406

  • Forest Investigative Site 050

    Chesterfield, Michigan, 48047

  • Forest Investigative Site 043

    Chicago, Illinois, 60616

  • Forest Investigative Site 078

    Christiansburg, Virginia, 24073

  • Forest Investigative Site 062

    Cincinnati, Ohio, 45219

  • Forest Investigative Site 020

    Colorado Springs, Colorado, 80904

  • Forest Investigative Site 061

    Columbus, Ohio, 43213

  • Forest Investigative Site 068

    Cumberland, Rhode Island, 02864

  • Forest Investigative Site 088

    Davidson, North Carolina, 28036

  • Forest Investigative Site 024

    DeLand, Florida, 32720

  • Forest Investigative Site 044

    Evansville, Indiana, 47714

  • Forest Investigative Site 056

    Fargo, North Dakota, 58103

  • Forest Investigative Site 051

    Flat Rock, North Carolina, 28731

  • Forest Investigative Site 049

    Flint, Michigan, 48504

  • Forest Investigative Site 001

    Foley, Alabama, 36535

  • Forest Investigative Site 014

    Fountain Valley, California, 92708

  • Forest Investigative Site 019

    Fresno, California, 93702

  • Forest Investigative Site 027

    Gainesville, Florida, 32607

  • Forest Investigative Site 017

    Garden Grove, California, 92843

  • Forest Investigative Site 010

    Gold River, California, 95670

  • Forest Investigative Site 052

    Greensboro, North Carolina, 27403

  • Forest Investigative Site 055

    Greensboro, North Carolina, 27410

  • Forest Investigative Site 048

    Hagerstown, Maryland, 21742

  • 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 067

    Levittown, Pennsylvania, 19056

  • Forest Investigative Site 009

    Lincoln, California, 95648

  • Forest Investigative Site 075

    Logan, Utah, 84341

  • Forest Investigative Site 045

    Madisonville, Kentucky, 42431

  • Forest Investigative Site 041

    Marietta, Georgia, 30060

  • Forest Investigative Site 066

    Medford, Oregon, 97504

  • Forest Investigative Site 060

    Mentor, Ohio, 44060

  • Forest Investigative Site 046

    Metairie, Louisiana, 70006

  • Forest Investigative Site 028

    Miami, Florida, 33185

  • Forest Investigative Site 012

    North Hollywood, California, 91606

  • Forest Investigative Site 003

    North Little Rock, Arkansas, 72217

  • Forest Investigative Site 084

    Ogden, Utah, 84341

  • Forest Investigative Site 064

    Oklahoma City, Oklahoma, 73103

  • Forest Investigative Site 063

    Oklahoma City, Oklahoma, 73120

  • Forest Investigative Site 058

    Omaha, Nebraska, 68114

  • Forest Investigative Site 057

    Omaha, Nebraska, 68134

  • Forest Investigative Site 011

    Orange, California, 92868

  • Forest Investigative Site 040

    Orlando, Florida, 32801

  • Forest Investigative Site 022

    Oviedo, Florida, 32765

  • Forest Investigative Site 080

    Philadelphia, Pennsylvania, 19140

  • Forest Investigative Site 007

    Phoenix, Arizona, 85029

  • Forest Investigative Site 034

    Port Orange, Florida, 32129

  • Forest Investigative Site 083

    Richardson, Texas, 75080

  • Forest Investigative Site 016

    Sacramento, California, 95821

  • 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 013

    San Diego, California, 92108

  • Forest Investigative Site 015

    Santa Ana, California, 92701

  • 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 008

    Tucson, Arizona, 85710

  • Forest Investigative Site 065

    Tulsa, Oklahoma, 74104

  • Forest Investigative Site 087

    Wadsworth, Ohio, 44281

  • Forest Investigative Site 047

    Watertown, Massachusetts, 02472

  • Forest Investigative Site 076

    West Jordan, Utah, 84088

  • Forest Investigative Site 039

    West Palm Beach, Florida, 33409

  • Forest Investigative Site 032

    Weston, Florida, 33331

  • Forest Investigative Site 059

    Williamsville, New York, 14221

  • Forest Investigative Site 053

    Winston-Salem, North Carolina, 27103

  • Forest Investigative Site 042

    Woodstock, Georgia, 30189

Other trials in United States

About this study

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

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.

Being tested
Linaclotide 145 micrograms, Linaclotide 290 micrograms, Placebo
Keywords
Opioid-Induced Constipation, Linaclotide, Linzess
Medical subject headings
Opioid-Induced Constipation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Linaclotide 145 microgramsDrug

    Also called Linzess

  • Linaclotide 290 microgramsDrug

    Also called Linzess

  • PlaceboDrug

    Matching placebo

Study groups in NCT02270983
Study groupRoleWhat they receive
Linaclotide 145 microgramsExperimentalOral 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.
Receives: Drug: Linaclotide 145 micrograms
Linaclotide 290 microgramsExperimentalOral 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.
Receives: Drug: Linaclotide 290 micrograms
PlaceboExperimentalOral 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.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline (Week 0) to Week 8

Secondary outcomes (5)

  1. 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

    Measured: Baseline (Day 0) up to 8 weeks

  2. 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.

    Measured: 8-week treatment period

  3. Change From Baseline in 8-Week Stool Consistency

    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)

    Measured: Baseline (Week 0) to Week 8

  4. 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."

    Measured: Baseline (Week 0) to Week 8

  5. 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.

    Measured: Baseline (Week 0) to Week 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Oct 2014 (estimated)
  2. Study start31 Oct 2014
  3. Primary completion31 Aug 2015
  4. Study completion31 Oct 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
254 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02270983
Sponsor's protocol ID
LIN-MD-40
Status last verified
Apr 2019
First submitted
16 Oct 2014
Last updated
8 Apr 2019
Data monitoring committee
No

Publications

  • 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.

    PubMed 32310620

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Linaclotide 145 micrograms and Linaclotide 290 micrograms in people with Opioid-Induced Constipation, run by Forest Laboratories at 77 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 77 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in 8-Week SBM Frequency Rate (SBMs/Week) (time frame: Baseline (Week 0) to Week 8). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02270983, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2019.

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