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Irritable Bowel Syndrome Characterized by ConstipationPhase 3NCT00948818

Trial of Linaclotide Administered to Patients With Irritable Bowel Syndrome With Constipation

A Phase 3 study testing Linaclotide 290 micrograms in people with Irritable Bowel Syndrome Characterized by Constipation, run by Forest Laboratories at 118 sites in 2 countries.

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 objective of this trial is to determine the efficacy and safety of linaclotide administered to patients with irritable bowel syndrome with constipation (IBS-C). The primary efficacy parameter is the percentage of patients in each treatment group that meet the protocol definition for Abdominal Pain and Complete… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
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
803 participants
Where
118 sitesin 2 countries
Study dates
Jul 2009to Aug 2010
Phase
Phase 3
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 meets protocol criteria for IBS: reports abdominal discomfort or pain that has two or more of the following three features:
  • Relieved with defecation
  • Onset associated with a change in frequency of stool
  • Onset associated with a change in form (appearance) of stool
  • Patient reports < 3 bowel movements (BMs) per week (in the absence of any laxative, suppository, or enema use during the preceding 24 hours) and reports straining, lumpy or hard stools, and/or sensation of incomplete evacuation during > 25% of BMs
  • Patient has successfully completed protocol procedures (with no clinically significant findings): physical exam, 12-lead ECG, or clinical laboratory tests (some patients may require a colonoscopy per American Gastroenterological Association (AGA) guidelines)
  • Patient is compliant with Interactive Voice Response System (IVRS) for daily diary reporting of BM habits and IBS symptoms

Who cannot join

  • Patient has history of loose or watery stools for >25% of BMs
  • Patient has a structural abnormality of the gastrointestinal (GI) tract or a history of a disease or condition that can affect GI motility
  • Patient has any protocol-excluded or clinically significant medical or surgical history or concomitant medication use that could confound the study assessments

Trial locations and contacts

118 sites in 2 countries.

118 sites in 2 countries

United States111 sites

  • Forest Investigative Site 052

    Albuquerque, New Mexico, 87106

  • Forest Investigative Site 029

    Arkansas City, Kansas, 67005

  • Forest Investigative Site 032

    Atlanta, Georgia, 30342

  • Forest Investigative Site 103

    Atlanta, Georgia, 30342

  • Forest Investigative Site 099

    Austin, Texas, 78705

  • Forest Investigative Site 132

    Baton Rouge, Louisiana, 70808

  • Forest Investigative Site 049

    Bellevue, Washington, 98402

  • Forest Investigative Site 037

    Birmingham, Alabama, 35209

  • Forest Investigative Site 036

    Birmingham, Alabama, 35215

  • Forest Investigative Site 042

    Boca Raton, Florida, 33486

  • Forest Investigative Site 122

    Boone, North Carolina, 28607

  • Forest Investigative Site 001

    Boston, Massachusetts, 02135

  • Forest Investigative Site 021

    Boulder, Colorado, 80304

  • Forest Investigative Site 003

    Bradenton, Florida, 34203

  • Forest Investigative Site 137

    Brandon, Florida, 33511

  • Forest Investigative Site 035

    Brooklyn, New York, 11214

  • Forest Investigative Site 070

    Brooksville, Florida, 34613

  • Forest Investigative Site 094

    Burbank, California, 91505

  • Forest Investigative Site 080

    Chandler, Arizona, 85225

  • Forest Investigative Site 054

    Charlottesville, Virginia, 22911

  • Forest Investigative Site 064

    Chaska, Minnesota, 55318

  • Forest Investigative Site 013

    Chevy Chase, Maryland, 20815

  • Forest Investigative Site 061

    Christianburg, Virginia, 24073

  • Forest Investigative Site 028

    Cincinnati, Ohio, 45219

  • Forest Investigative Site 044

    Cleveland, Ohio, 44122

  • Forest Investigative Site 019

    Colorado Springs, Colorado, 80907

  • Forest Investigative Site 123

    Columbus, Ohio, 43215

  • Forest Investigative Site 002

    Dallas, Texas, 75234

  • Forest Investigative Site 130

    Dayton, Ohio, 45432

  • Forest Investigative Site 034

    Denver, Colorado, 80205

  • Forest Investigative Site 026

    Encinitas, California, 92024

  • Forest Investigative Site 047

    Evansville, Indiana, 47714

  • Forest Investigative Site 072

    Fayetteville, North Carolina, 28304

  • Forest Investigative Site 096

    Foothill Ranch, California, 92610

  • Forest Investigative Site 018

    Fort Myers, Florida, 33916

  • Forest Investigative Site 017

    Great Neck, New York, 11021

  • Forest Investigative Site 011

    Great Neck, New York, 11023

  • Forest Investigative Site 016

    Greensboro, North Carolina, 27403

  • Forest Investigative Site 121

    Greenville, South Carolina, 29615

  • Forest Investigative Site 069

    Greer, South Carolina, 29651

  • Forest Investigative Site 131

    Greer, South Carolina, 29651

  • Forest Investigative Site 006

    Hagerstown, Maryland, 21742

  • Forest Investigative Site 119

    Hickory, North Carolina, 28601

  • Forest Investigative Site 041

    Houston, Texas, 77090

  • Forest Investigative Site 110

    Houston, Texas, 77090

  • Forest Investigative Site 135

    Hueytown, Alabama, 35023

  • Forest Investigative Site 014

    Huntsville, Alabama, 35801

  • Forest Investigative Site 055

    Idaho Falls, Idaho, 83404

  • Forest Investigative Site 046

    Iowa City, Iowa, 52242

  • Forest Investigative Site 030

    Jupiter, Florida, 33458

  • Forest Investigative Site 125

    Kalamazoo, Michigan, 49048

  • Forest Investigative Site 077

    Kissimmee, Florida, 34741

  • Forest Investigative Site 063

    Lake Jackson, Texas, 77566

  • Forest Investigative Site 098

    Lakewood, Washington, 98499

  • Forest Investigative Site 067

    Lexington, Kentucky, 40509

  • Forest Investigative Site 074

    Longmont, Colorado, 80501

  • Forest Investigative Site 057

    Los Angeles, California, 90036

  • Forest Investigative Site 073

    Lutherville, Maryland, 21093

  • Forest Investigative Site 114

    Madisonville, Kentucky, 42431

  • Forest Investigative Site 033

    Marietta, Georgia, 30060

  • Forest Investigative Site 020

    Marietta, Georgia, 30067

  • Forest Investigative Site 053

    Mesa, Arizona, 85210

  • Forest Investigative Site 133

    Miami, Florida, 33126

  • Forest Investigative Site 031

    Miami, Florida, 33143

  • Forest Investigative Site 083

    Milwaukee, Wisconsin, 53209

  • Forest Investigative Site 097

    Mission Hills, California, 91345

  • Forest Investigative Site 025

    Nashville, Tennessee, 37205

  • Forest Investigative Site 129

    New Smyrna Beach, Florida, 32168

  • Forest Investigative Site 007

    Newport News, Virginia, 23606

  • Forest Investigative Site 009

    Newton, Kansas, 67114

  • Forest Investigative Site 060

    Norfolk, Virginia, 23502

  • Forest Investigative Site 075

    Norfolk, Virginia, 23507

  • Forest Investigative Site 108

    Ocala, Florida, 34471

  • Forest Investigative Site 082

    Oklahoma City, Oklahoma, 73104

  • Forest Investigative Site 005

    Orange, California, 92869

  • Forest Investigative Site 092

    Orlando, Florida, 32806

  • Forest Investigative Site 038

    Panama City, Florida, 32405

  • Forest Investigative Site 027

    Pembroke Pines, Florida, 33024

  • Forest Investigative Site 078

    Peoria, Arizona, 85381

  • Forest Investigative Site 101

    Phoenix, Arizona, 85012

  • Forest Investigative Site 128

    Phoenix, Arizona, 85018

  • Forest Investigative Site 039

    Pittsburgh, Pennsylvania, 15206

  • Forest Investigative Site 088

    Raleigh, North Carolina, 27612

  • Forest Investigative Site 050

    Richmond, Virginia, 23294

  • Forest Investigative Site 043

    Rockford, Illinois, 61107

  • Forest Investigative Site 089

    Salt Lake City, Utah, 84102

  • Forest Investigative Site 091

    Salt Lake City, Utah, 84132

  • Forest Investigative Site 100

    Salt Lake City, Utah, 84148

  • Forest Investigative Site 095

    San Antonio, Texas, 78209

  • Forest Investigative Site 076

    San Antonio, Texas, 78229

  • Forest Investigative Site 051

    Scottsdale, Arizona, 85251

  • Forest Investigative Site 134

    Setauket, New York, 11733

  • Forest Investigative Site 124

    Shreveport, Louisiana, 71101

  • Forest Investigative Site 004

    St Louis, Missouri, 63128

  • Forest Investigative Site 045

    St. Petersburg, Florida, 33709

  • Forest Investigative Site 015

    Tampa, Florida, 33606

  • Forest Investigative Site 104

    Trinity, Florida, 34655

  • Forest Investigative Site 136

    Tucson, Arizona, 85712

  • Forest Investigative Site 087

    Tucson, Arizona, 85741

  • Forest Investigative Site 102

    Tulsa, Oklahoma, 74135

  • Forest Investigative Site 085

    Vineland, New Jersey, 08360

  • Forest Investigative Site 058

    Waterbury, Connecticut, 06708

  • Forest Investigative Site 066

    Wenatchee, Washington, 98801

  • Forest Investigative Site 024

    Westlake Village, California, 91361

  • Forest Investigative Site 010

    Wheat Ridge, Colorado, 80033

  • Forest Investigative Site 023

    Wichita, Kansas, 67205

  • Forest Investigative Site 093

    Wichita, Kansas, 67207

  • Forest Investigative Site 056

    Wilmington, North Carolina, 28401

  • Forest Investigative Site 065

    Winston-Salem, North Carolina, 27103

  • Forest Investigative Site 040

    Woodstock, Georgia, 30189

  • Forest Investigative Site 068

    Zephyrhills, Florida, 33542

Other trials in United States

Canada7 sites

  • Forest Investigative Site 113

    Greater Sudbury, Ontario, P3E 1H5

  • Forest Investigative Site 107

    Hamilton, Ontario, L8N 4A6

  • Forest Investigative Site 112

    Newmarket, Ontario, L3Y 7V1

  • Forest Investigative Site 106

    Ottawa, Ontario, K2C 3R2

  • Forest Investigative Site 115

    Sarnia, Ontario, N7T 4X3

  • Forest Investigative Site 008

    Toronto, Ontario, M3N 2V7

  • Forest Investigative Site 116

    Toronto, Ontario, M4S 1Y2

Other trials in Canada

About this study

Official title: A Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial of Linaclotide Administered Orally for 12 Weeks Followed by a 4-Week Randomized Withdrawal Period in Patients With Irritable Bowel Syndrome With Constipation

The objective of this trial is to determine the efficacy and safety of linaclotide administered to patients with irritable bowel syndrome with constipation (IBS-C).

The primary efficacy parameter is the percentage of patients in each treatment group that meet the protocol definition for Abdominal Pain and Complete Spontaneous Bowel Movement (APC) Responder.

Being tested
Linaclotide 290 micrograms, Matching placebo
Keywords
Irritable Bowel Syndrome, Constipation, Linaclotide
Medical subject headings
Irritable Bowel Syndrome, Constipation

What participants receive

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

  • Linaclotide 290 microgramsDrug

    Oral, once daily each morning at least 30 minutes before breakfast for the duration of the study

  • Matching placeboDrug

    Oral, once daily each morning at least 30 minutes before breakfast for the duration of the study

Study groups in NCT00948818
Study groupRoleWhat they receive
LinaclotideExperimentalLinaclotide 290 micrograms
Receives: Drug: Linaclotide 290 micrograms
PlaceboPlacebo comparatorMatching placebo
Receives: Drug: Matching placebo

What is being measured

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

  1. Abdominal Pain and Complete Spontaneous Bowel Movement (APC) Responder, 9 Out of 12 Weeks

    A patient is considered to be an APC responder if, for at least 9 out of the 12 weeks of the treatment period, the patient had at least 3 CSBMs, experienced an increase of at least 1 CSBM from baseline, and experienced a decrease of at least 30 percent in their Abdominal Pain (AP) score from baseline during a particular week.

    The AP score assesses the worst of a patient's AP in the past 24 hours using an 11-point scale (from 0-10), where 0 represents no AP and 10 represents very severe AP.

    A CSBM is defined as a spontaneous bowel movement, associated with a sense of complete evacuation.

    Measured: Change from Baseline to Week 12

  2. Complete Spontaneous Bowel Movement (CSBM) 3+1 Responder, 9 Out of 12 Weeks

    A patient is considered to be a CSBM 3+1 responder if, for at least 9 out of the 12 weeks of the treatment period, the patient had at least 3 CSBMs and experienced an increase of at least 1 CSBM from baseline during a particular week.

    A CSBM was defined as a Spontaneous Bowel Movement (SBM) that was associated with a sense of complete evacuation.

    An SBM was defined as a bowel movement (BM) that occurred in the absence of laxative, enema, or suppository use on either the calendar day of the BM or the calendar day before the BM.

    Measured: Change from Baseline to Week 12

  3. Abdominal Pain Responder, 9 Out of 12 Weeks

    A patient is considered to be an abdominal pain responder if, for at least 9 out of the 12 weeks of the treatment period, they experienced a decrease of at least 30 percent in the mean abdominal pain score from baseline during a particular week.

    The Abdominal Pain score assesses the worst of a patient's abdominal pain in the past 24 hours using an 11-point scale (from 0-10), where 0 represents no abdominal pain and 10 represents very severe abdominal pain.

    Measured: Change from Baseline to Week 12

  4. Abdominal Pain and Complete Spontaneous Bowel Movement (APC) Responder, 6 Out of 12 Weeks.

    A patient is considered an APC responder if, for at least 6 of the 12 weeks of the treatment, the patient experienced an increase of at least 1 Complete Spontaneous Bowel Movement (CSBM) from baseline and experienced a decrease of at least 30 percent in their Abdominal Pain (AP)score during a particular week.

    The AP score assesses the worst of a patient's AP in the past 24 hours using an 11-point scale (from 0-10), where 0 represents no AP and 10 represents very severe AP.

    A CSBM was defined as a Spontaneous Bowel Movement (SBM) that was associated with a sense of complete evacuation.

    Measured: Change from Baseline to Week 12

Secondary outcomes (10)

  1. 12-Week Complete Spontaneous Bowel Movement (CSBM) Frequency Rate

    The number of CSBMs per week.

    Measured: Change from Baseline to Week 12

  2. 12-Week Spontaneous Bowl Movement (SBM) Frequency Rate

    The number of Spontaneous Bowl Movements experienced per week.

    Measured: Change from Baseline to Week 12

  3. 12-Week Stool Consistency

    The consistency of each BM was assessed by patients using the 7-point Bristol Stool Form Scale (BSFS) from 1 to 7.

    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 stool
    7. = watery, no solid pieces [entirely liquid]).

    Measured: Change from Baseline to Week 12

  4. 12-Week Severity of Straining

    Straining is measured on a 5-point scale where a value of 1 is "not at all" and a value of 5 is "an extreme amount.

    Measured: Change from Baseline to Week 12

  5. 12-Week Change in Abdominal Pain Score

    Abdominal Pain at its worst (in the last 24 hours) is based on an 11-point scale where 0 represents no abdominal pain and 10 represents very severe abdominal pain.

    Measured: Change from Baseline to Week 12

  6. 12-Week Change in Abdominal Discomfort

    Abdominal Discomfort is measured on an 11-point scale where a value of 0 is "none" and a value of 10 is "very severe."

    Measured: Change from Baseline to Week 12

  7. 12-Week Change in Bloating

    Bloating was assessed on an 11-point scale where a value of 0 is "none" and a value of 10 is "very severe".

    Measured: Change from Baseline to Week 12

  8. Complete Spontaneous Bowl Movement (CSBM) Responder for 6 Weeks Out of 12 Weeks of Treatment

    A patient is considered to be a CSBM responder if, for at least 6 out of the 12 weeks of the treatment period, an increase of at least 1 CSBM per week from baseline was experienced.

    Measured: Change from Baseline to Week 12

  9. Abdominal Pain Responder for 6 Out of 12 Weeks

    A patient is considered to be an abdominal pain responder if, for at least 6 out of the 12 weeks of the treatment period, they experienced a decrease of 30 percent or more in the abdominal pain score from baseline.

    The Abdominal Pain score assesses the worst of a patient's abdominal pain in the past 24 hours using an 11-point scale (from 0-10), where 0 represents no abdominal pain and 10 represents very severe abdominal pain.

    Measured: Change from Baseline to Week 12

  10. 12-Week Percent of Abdominal Pain-free (APF) Days

    Abdominal pain free (APF) days are those days where the patient reported a score of '0' for abdominal pain at its worst

    Abdominal Pain at its worst (in the last 24 hours) is based on an 11-point scale where 0 represents no abdominal pain and 10 represents very severe abdominal pain.

    Measured: Change from Baseline to Week 12

Timeline

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

  1. First posted29 Jul 2009 (estimated)
  2. Study startJul 2009
  3. Primary completionJul 2010
  4. Study completionAug 2010

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
803 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00948818
Sponsor's protocol ID
LIN-MD-31
Status last verified
Dec 2012
First submitted
28 Jul 2009
Last updated
30 Jan 2013
Data monitoring committee
No

Publications

  • Rao SS, Quigley EM, Shiff SJ, Lavins BJ, Kurtz CB, MacDougall JE, Currie MG, Johnston JM. Effect of linaclotide on severe abdominal symptoms in patients with irritable bowel syndrome with constipation. Clin Gastroenterol Hepatol. 2014 Apr;12(4):616-23. doi: 10.1016/j.cgh.2013.09.022. Epub 2013 Sep 25.

    PubMed 24075889

  • Quigley EM, Tack J, Chey WD, Rao SS, Fortea J, Falques M, Diaz C, Shiff SJ, Currie MG, Johnston JM. Randomised clinical trials: linaclotide phase 3 studies in IBS-C - a prespecified further analysis based on European Medicines Agency-specified endpoints. Aliment Pharmacol Ther. 2013 Jan;37(1):49-61. doi: 10.1111/apt.12123. Epub 2012 Nov 1.

    PubMed 23116208

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Linaclotide 290 micrograms in people with Irritable Bowel Syndrome Characterized by Constipation, run by Forest Laboratories at 118 sites in 2 countries.

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 7 inclusion and 3 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 30 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 118 sites in United States, Canada. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 30 Jan 2013). 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?

Abdominal Pain and Complete Spontaneous Bowel Movement (APC) Responder, 9 Out of 12 Weeks (time frame: Change from Baseline to Week 12). The study lists 4 primary outcomes in all. 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 NCT00948818, which also lists 2 linked publications.

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 30 Jan 2013.

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