AzTrials
AzTrials

Chronic ConstipationPhase 3NCT01642914

Safety and Efficacy of Linaclotide in Patients With Chronic Constipation and Prominent Abdominal Bloating

A Phase 3 study testing Linaclotide 290 micrograms and Linaclotide 145 micrograms in people with Chronic Constipation and Constipation, run by Forest Laboratories at 151 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 purpose of this study is to evaluate the efficacy and safety of linaclotide compared with placebo in patients with chronic constipation (CC) and prominent abdominal bloating. This study includes an up to 3-week screening period and a 2-3 week pretreatment period. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Chronic Constipation, Constipation
What is being tested?
Linaclotide 290 micrograms and Linaclotide 145 micrograms
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
487 participants
Where
151 sitesin 2 countries
Study dates
Aug 2012to Aug 2013
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
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Patient has completed a colonoscopy according to the American Gastroenterological Association criteria with no clinically significant findings
  • Patient has successfully completed protocol procedures (with no clinically significant findings)
  • Patient meets protocol criteria for Chronic Constipation(CC): < 3 bowel movements per week and reports one or more of the following symptoms for at least 12 weeks:
  • Straining during more than 25% of BMs
  • Lumpy or hard stools during more than 25% of BMs
  • Sensation of incomplete evacuation during more than 25% of BMs
  • Patient demonstrates continued chronic constipation and bloating through Pretreatment Period
  • Patient is compliant with Interactive voice response System (IVRS)

Who cannot join

  • Patient has a history of loose or watery stools
  • Patient has symptoms of or been diagnosed with Irritable Bowel Syndrome (IBS)
  • 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

151 sites in 2 countries.

151 sites in 2 countries

United States146 sites

  • Forest Investigative Site 063

    Albuquerque, New Mexico, 87106

  • Forest Investigative Site 093

    Albuquerque, New Mexico, 87108

  • Forest Investigative Site 106

    Anaheim, California, 92801

  • Forest Investigative Site 107

    Anderson, Indiana, 46011

  • Forest Investigative Site 142

    Asheboro, North Carolina, 27203

  • Forest Investigative Site 094

    Asheville, North Carolina, 28801

  • Forest Investigative Site 125

    Austin, Texas, 78756

  • Forest Investigative Site 062

    Baltimore, Maryland, 21215

  • Forest Investigative Site 121

    Baton Rouge, Louisiana, 70809

  • Forest Investigative Site 075

    Boone, North Carolina, 28607

  • Forest Investigative Site 006

    Boston, Massachusetts, 02135

  • Forest Investigative Site 012

    Boulder, Colorado, 80304

  • Forest Investigative Site 091

    Boynton Beach, Florida, 33426

  • Forest Investigative Site 047

    Bradenton, Florida, 34208

  • Forest Investigative Site 007

    Bristol, Connecticut, 06010

  • Forest Investigative Site 044

    Brooklyn, New York, 11206

  • Forest Investigative Site 042

    Brooksville, Florida, 34601

  • Forest Investigative Site 020

    Chandler, Arizona, 85224

  • Forest Investigative Site 102

    Chandler, Arizona, 85224

  • Forest Investigative Site 123

    Chapel Hill, North Carolina, 27599-7080

  • Forest Investigative Site 053

    Charlottesville, Virginia, 22911

  • Forest Investigative Site 129

    Chattanooga, Tennessee, 37421

  • Forest Investigative Site 108

    Chesapeake, Virginia, 23320

  • Forest Investigative Site 136

    Chesapeake, Virginia, 23320

  • Forest Investigative Site 070

    Chesterfield, Michigan, 48047

  • Forest Investigative Site 008

    Chevy Chase, Maryland, 20815

  • Forest Investigative Site 148

    Christiansburg, Virginia, 24073

  • Forest Investigative Site 025

    Cincinnati, Ohio, 45242

  • Forest Investigative Site 120

    Cincinnati, Ohio, 45249

  • Forest Investigative Site 056

    Cleveland, Ohio, 44122

  • Forest Investigative Site 036

    Clifton, New Jersey, 07012

  • Forest Investigative Site 117

    Clive, Iowa, 50325

  • Forest Investigative Site 146

    Clive, Iowa, 50325

  • Forest Investigative Site 041

    Colorado Springs, Colorado, 80904

  • Forest Investigative Site 045

    Colorado Springs, Colorado, 80907

  • Forest Investigative Site 026

    Columbus, Ohio, 43215

  • Forest Investigative Site 133

    Coral Gables, Florida, 33134

  • Forest Investigative Site 092

    Dakota Dunes, South Dakota, 57049

  • Forest Investigative Site 035

    Dallas, Texas, 75231

  • Forest Investigative Site 005

    Dallas, Texas, 75234

  • Forest Investigative Site 143

    Davenport, Iowa, 52807

  • Forest Investigative Site 140

    Davidson, North Carolina, 28036

  • Forest Investigative Site 098

    Dayton, Ohio, 45415

  • Forest Investigative Site 090

    Dayton, Ohio, 45432

  • Forest Investigative Site 131

    DeLand, Florida, 32720

  • Forest Investigative Site 039

    Fayetteville, North Carolina, 28304

  • Forest Investigative Site 051

    Fort Myers, Florida, 33916

  • Forest Investigative Site 111

    Fort Worth, Texas, 76135

  • Forest Investigative Site 077

    Fremont, Nebraska, 68025

  • Forest Investigative Site 149

    Glendale, Arizona, 85308

  • Forest Investigative Site 126

    Goodyear, Arizona, 85395

  • Forest Investigative Site 017

    Great Neck, New York, 11021

  • Forest Investigative Site 031

    Greensboro, North Carolina, 27403

  • Forest Investigative Site 029

    Greensboro, North Carolina, 27408

  • Forest Investigative Site 078

    Greensboro, North Carolina, 27408

  • Forest Investigative Site 116

    Greer, South Carolina, 29650

  • Forest Investigative Site 014

    Hagerstown, Maryland, 21742

  • Forest Investigative Site 084

    Harrisburg, North Carolina, 28075

  • Forest Investigative Site 052

    Henderson, Nevada, 89014

  • Forest Investigative Site 073

    Hickory, North Carolina, 28601

  • Forest Investigative Site 050

    Hickory, North Carolina, 28602

  • Forest Investigative Site 139

    High Point, North Carolina, 27262

  • Forest Investigative Site 100

    Houston, Texas, 77034

  • Forest Investigative Site 015

    Idaho Falls, Idaho, 83404

  • Forest Investigative Site 137

    Inverness, Florida, 34452

  • Forest Investigative Site 055

    Iowa City, Iowa, 52242

  • Forest Investigative Site 141

    Jackson, Mississippi, 39202

  • Forest Investigative Site 114

    Jacksonville, Florida, 32205

  • Forest Investigative Site 004

    Jupiter, Florida, 33458

  • Forest Investigative Site 067

    Katy, Texas, 77450

  • Forest Investigative Site 138

    Kingsport, Tennessee, 37660

  • Forest Investigative Site 016

    Kissimmee, Florida, 34741

  • Forest Investigative Site 082

    La Crosse, Wisconsin, 54601

  • Forest Investigative Site 104

    Laguna Hills, California, 92653

  • Forest Investigative Site 080

    Las Vegas, Nevada, 89121

  • Forest Investigative Site 097

    Lauderdale Lakes, Florida, 33319

  • Forest Investigative Site 081

    Levittown, Pennsylvania, 19056

  • Forest Investigative Site 128

    Lexington, Kentucky, 40509

  • Forest Investigative Site 060

    Longmont, Colorado, 80501

  • Forest Investigative Site 072

    Lynchburg, Virginia, 24502

  • Forest Investigative Site 134

    Madisonville, Kentucky, 42431

  • Forest Investigative Site 021

    Marietta, Georgia, 30060

  • Forest Investigative Site 011

    Marietta, Georgia, 30067

  • Forest Investigative Site 088

    Marlton, New Jersey, 08053

  • Forest Investigative Site 085

    Mentor, Ohio, 44060

  • Forest Investigative Site 124

    Metairie, Louisiana, 70006

  • Forest Investigative Site 003

    Miami, Florida, 33143

  • Forest Investigative Site 002

    Miami, Florida, 33183

  • Forest Investigative Site 096

    Milwaukee, Wisconsin, 53215

  • Forest Investigative Site 066

    Mission Hills, California, 91345

  • Forest Investigative Site 101

    Monroe, Louisiana, 71201

  • Forest Investigative Site 130

    New Smyrna Beach, Florida, 32168

  • Forest Investigative Site 069

    Newport News, Virginia, 23606

  • Forest Investigative Site 028

    Newton, Kansas, 67114

  • Forest Investigative Site 013

    Norfolk, Virginia, 23502

  • Forest Investigative Site 135

    North Little Rock, Arkansas, 72117

  • Forest Investigative Site 040

    Ocala, Florida, 34471

  • Forest Investigative Site 019

    Ogden, Utah, 84405

  • Forest Investigative Site 118

    Oklahoma City, Oklahoma, 73104

  • Forest Investigative Site 048

    Omaha, Nebraska, 68134

  • Forest Investigative Site 083

    Orlando, Florida, 32806

  • Forest Investigative Site 112

    Overland Park, Kansas, 66215

  • Forest Investigative Site 150

    Oviedo, Florida, 32765

  • Forest Investigative Site 049

    Pasadena, Texas, 77505

  • Forest Investigative Site 122

    Peoria, Illinois, 61602

  • Forest Investigative Site 018

    Phoenix, Arizona, 85018

  • Forest Investigative Site 061

    Phoenix, Arizona, 85020

  • Forest Investigative Site 001

    Pittsburgh, Pennsylvania, 15206

  • Forest Investigative Site 132

    Port Orange, Florida, 32129

  • Forest Investigative Site 027

    Raleigh, North Carolina, 27612

  • Forest Investigative Site 110

    Reading, Pennsylvania, 19606

  • Forest Investigative Site 038

    Richmond, Virginia, 23294

  • Forest Investigative Site 043

    Rockford, Illinois, 61107

  • Forest Investigative Site 105

    Salt Lake City, Utah, 84107

  • Forest Investigative Site 030

    San Antonio, Texas, 78209

  • Forest Investigative Site 076

    San Antonio, Texas, 78229

  • Forest Investigative Site 095

    San Carlos, California, 94070

  • Forest Investigative Site 009

    San Diego, California, 92108

  • Forest Investigative Site 113

    Sandy City, Utah, 84094

  • Forest Investigative Site 109

    Sandy Springs, Georgia, 30328

  • Forest Investigative Site 151

    Santa Monica, California, 90404

  • Forest Investigative Site 022

    Scottsdale, Arizona, 85251

  • Forest Investigative Site 127

    Seminole, Florida, 33777

  • Forest Investigative Site 058

    Shreveport, Louisiana, 71101

  • Forest Investigative Site 099

    Shreveport, Louisiana, 71103

  • Forest Investigative Site 046

    Simpsonville, South Carolina, 29681

  • Forest Investigative Site 103

    Spokane, Washington, 99208

  • Forest Investigative Site 087

    St. Petersburg, Florida, 33709

  • Forest Investigative Site 119

    Statesville, North Carolina, 28625

  • Forest Investigative Site 037

    Stockbridge, Georgia, 30281

  • Forest Investigative Site 065

    Sugarland, Texas, 77479

  • Forest Investigative Site 064

    Tampa, Florida, 33606

  • Forest Investigative Site 024

    Towson, Maryland, 21286

  • Forest Investigative Site 145

    Traverse City, Michigan, 49684

  • Forest Investigative Site 079

    Tucson, Arizona, 85704

  • Forest Investigative Site 071

    Tucson, Arizona, 85712

  • Forest Investigative Site 033

    Vineland, New Jersey, 08360

  • Forest Investigative Site 068

    Wadsworth, Ohio, 44281

  • Forest Investigative Site 153

    Waterbury, Connecticut, 06708

  • Forest Investigative Site 010

    Westlake Village, California, 91361

  • Forest Investigative Site 034

    Wichita, Kansas, 67205

  • Forest Investigative Site 032

    Wichita, Kansas, 67207

  • Forest Investigative Site 089

    Wilmington, North Carolina, 28401

  • Forest Investigative Site 074

    Winston-Salem, North Carolina, 27103

  • Forest Investigative Site 023

    Woodstock, Georgia, 30189

  • Forest Investigative Site 115

    Zephyrhills, Florida, 33542

Other trials in United States

Canada5 sites

  • Forest Investigative Site 054

    Greater Sudbury, Ontario, P3E 1H5

  • Forest Investigative Site 059

    Sarnia, Ontario, N7T 4X3

  • Forest Investigative Site 086

    Toronto, Ontario, M4S 1Y2

  • Forest Investigative Site 147

    Toronto, Ontario, M9W 4L6

  • Forest Investigative Site 152

    Vaughan, Ontario, L4L 4Y7

Other trials in Canada

About this study

Official title: Phase 3b, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial of Linaclotide Administered Orally for 12 Weeks to Patients With Chronic Constipation and Prominent Abdominal Bloating at Baseline

The purpose of this study is to evaluate the efficacy and safety of linaclotide compared with placebo in patients with chronic constipation (CC) and prominent abdominal bloating. This study includes an up to 3-week screening period and a 2-3 week pretreatment period. Patients who are eligible will be randomized to one of two doses of linaclotide or placebo for 12 weeks. This 12-week study will assess the effects of linaclotide on bowel movement frequency, as well as other abdominal and bowel symptoms of CC.

Being tested
Linaclotide 290 micrograms, Linaclotide 145 micrograms, Matching placebo
Keywords
Chronic Constipation, Abdominal Bloating, Linaclotide
Medical subject headings
Constipation

What participants receive

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

  • Linaclotide 290 microgramsDrug

    oral capsule, taken once daily each morning at least 30 minutes before breakfast

  • Linaclotide 145 microgramsDrug

    oral capsule, taken once daily each morning at least 30 minutes before breakfast

  • Matching placeboDrug

    oral capsule, taken once daily each morning at least 30 minutes before breakfast

Study groups in NCT01642914
Study groupRoleWhat they receive
Linaclotide 290 microgramsExperimentalLinaclotide 290 micrograms
Receives: Drug: Linaclotide 290 micrograms
Linaclotide 145 MicrogramsExperimentalLinaclotide 145 micrograms
Receives: Drug: Linaclotide 145 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. 9/12 Week Complete Spontaneous Bowel Movement (CSBM) 3+1 Responder

    A 9/12 Week CSBM 3+1 Responder is a patient who is a CSBM 3+1 Weekly Responder for at least 9 out of the 12 weeks of the Treatment Period. A CSBM 3+1 Weekly Responder is a patient who had a CSBM Weekly Frequency Rate that was 3 or greater and increased by 1 or more from baseline.

    Measured: 12-week treatment period

Secondary outcomes (23)

  1. 9/12 Week Complete Spontaneous Bowel Movement (CSBM) 3+1 Responder

    A 9/12 Week CSBM 3+1 Responder is a patient who is a CSBM 3+1 Weekly Responder for at least 9 out of the 12 weeks of the Treatment Period. A CSBM 3+1 Weekly Responder is a patient who had a CSBM Weekly Frequency Rate that was 3 or greater and increased by 1 or more from baseline.

    Measured: 12-week treatment period

  2. Change From Baseline in 12-Week Abdominal Bloating

    Abdominal Bloating was measured daily using an 11-point Numerical Rating Scale (NRS) where a value of 0 represents no abdominal bloating and a value of 10 represents very severe abdominal bloating. The abdominal bloating score from Baseline is derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization up to the time of randomization (Visit 3, Day 1). The change from baseline in 12-Week Abdominal Bloating score is the difference between the average nonmissing daily patient assessments of abdominal bloating scores during the 14 day Baseline period, and the average of the nonmissing daily patient assessments of abdominal bloating scores reported during the 12 week Treatment Period.

    Measured: Baseline and 12-week treatment period

  3. Percent Change From Baseline in 12-week Abdominal Bloating

    Abdominal Bloating was measured daily using an 11-point Numerical Rating Scale (NRS) where a value of 0 represents no abdominal bloating and a value of 10 represents very severe abdominal bloating. The abdominal bloating score from Baseline is derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization, up to the time of randomization (Visit 3, Day 1). The percent change from baseline in 12-Week Abdominal Bloating score is the percentage difference between the average nonmissing daily patient assessments score of abdominal bloating scores during the 14 day Baseline period, and the average of the nonmissing daily patient assessments of abdominal bloating scores reported during the 12 week Treatment Period.

    Measured: Baseline and 12-week treatment period

  4. Percent Change From Baseline in Abdominal Bloating at Week 12

    Abdominal bloating was measured daily using an 11-point Numerical Rating Scale (NRS) where a value of 0 represents no abdominal bloating and a value of 10 represents very severe abdominal bloating. The abdominal bloating score from Baseline is derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization, up to the time of randomization (Visit 3, Day 1). The percent change from baseline at Week 12 in Abdominal Bloating score is the percentage difference between the average nonmissing daily patient assessments of abdominal bloating scores during the 14 day Baseline period, and the average of the nonmissing daily patient assessments of abdominal bloating scores reported during Week 12.

    Measured: Baseline and Week 12

  5. 6/12 Week Abdominal Bloating 30% Responder

    A patient was a 6/12 week abdominal bloating 30% responder if, for at least 6 weeks of the 12-week treatment period, that patient's improvement from baseline in the weekly abdominal bloating score was ≥ 30% from baseline.

    Measured: 12-week treatment period

  6. Change From Baseline in 12-week CSBM Frequency Rate

    A patient's 12-week CSBM frequency rate from Baseline is derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization, up to the time of randomization (Visit 3, Day 1). A patient's 12-week CSBM frequency rate was the CSBM rate (CSBMs/week) calculated over the 12 weeks of the treatment period.

    Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison.

    Measured: Baseline and 12-week treatment period

  7. Change From Baseline in CSBM Frequency Rate at Week 1.

    A patient's CSBM frequency rate from Baseline is derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization, up to the time of randomization (Visit 3, Day 1). A patient's CSBM frequency rate at week 1 was the CSBM rate (CSBMs/week) calculated over that week.

    Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison.

    Measured: Baseline and Week 1

  8. Change From Baseline in CSBM Frequency Rate at Week 4.

    A patient's CSBM frequency rate from Baseline is derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization, up to the time of randomization (Visit 3, Day 1). A patient's CSBM frequency rate at week 4 was the CSBM rate (CSBMs/week) calculated over that week.

    Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison.

    Measured: Baseline and Week 4

  9. Change From Baseline in CSBM Frequency Rate at Week 8

    A patient's CSBM frequency rate from Baseline is derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization, up to the time of randomization (Visit 3, Day 1). A patient's CSBM frequency rate at week 8 was the CSBM rate (CSBMs/week) calculated over that week.

    Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison.

    Measured: Baseline and Week 8

  10. Change From Baseline in CSBM Frequency Rate at Week 12

    A patient's CSBM frequency rate from Baseline is derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization, up to the time of randomization (Visit 3, Day 1). A patient's CSBM frequency rate at week 12 was the CSBM rate (CSBMs/week) calculated over that week.

    Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison.

    Measured: Baseline and Week 12

  11. Change From Baseline in 12-Week SBM Frequency Rate

    A patient's Baseline SBM frequency rate is derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization, up to the time of randomization (Visit 3, Day 1). A patient's 12-week SBM frequency rate was the SBM rate (SBMs/week) calculated over the 12 weeks of the treatment period.

    Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison.

    Measured: 12-week treatment period

  12. Change From Baseline in SBM Frequency Rate at Week 1

    A patient's baseline SBM frequency rate is derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization, up to the time of randomization (Visit 3, Day 1). A patient's SBM frequency rate at week 1 was the SBM rate (SBMs/week) calculated over that week.

    Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison.

    Measured: Baseline and Week 1

  13. Change From Baseline in SBM Frequency Rate at Week 4

    A patient's baseline SBM frequency rate is derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization, up to the time of randomization (Visit 3, Day 1). A patient's SBM frequency rate at Week 4 was the SBM rate (SBMs/week) calculated over that week.

    Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison.

    Measured: Baseline and Week 4

  14. Change From Baseline in SBM Frequency Rate at Week 8

    A patient's baseline SBM frequency rate is derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization, up to the time of randomization (Visit 3, Day 1). A patient's SBM frequency rate at Week 8 was the SBM rate (SBMs/week) calculated over that week.

    Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison.

    Measured: Baseline and Week 8

  15. Change From Baseline in SBM Frequency Rate at Week 12

    A patient's baseline SBM frequency rate is derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization, up to the time of randomization (Visit 3, Day 1). A patient's SBM frequency rate at week 12 was the SBM rate (SBMs/week) calculated over that week.

    Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison.

    Measured: Baseline and Week 12

  16. Change From Baseline in the Number of Days With a Spontaneous Bowel Movement (SBM)

    A patient's baseline number of days with a Spontaneous Bowel Movement (SBM) was calculated as the number of days with at least 1 Spontaneous Bowel Movement (SBM), derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization, up to the time of randomization (Visit 3, Day 1). A patient's number of days with a SBM during the Treatment Period was calculated as the number of days with at least 1 Spontaneous Bowel Movement (SBM), divided by treatment duration (in days), and multiplied by 7.

    Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison.

    Measured: Baseline and 12-week treatment period

  17. SBM Within 24 Hours After the First Dose of Investigational Product

    The proportion of patients with a SBM within 24 hours of first taking investigational product in each linaclotide dose group was compared with the proportion in the placebo group using the Cochran-Mantel-Haenszel (CMH) test controlling for geographic region.

    Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison.

    Measured: 24 hours from first dose of investigational product (Day 1)

  18. Time to Spontaneous Bowel Movement (SBM) After the First Dose of Investigational Product

    Time to first SBM after the first dose of investigation product was defined as the number of hours between the time of the first dose of investigational product to the occurrence of the first SBM. Patients who did not achieve an SBM were considered censored, with time to censoring defined as the number of hours elapsing from the time of the first dose of investigational product was taken to the end of the day of the last dose, at 12:00 AM (24:00 military time).

    Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison.

    Measured: 12-week treatment period

  19. Change From Baseline in 12-week Stool Consistency

    Stool consistency was measured using the 7-point Bristol Stool Form Scale (BSFS):

    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]

    A patient's BSFS score for the baseline period (14 days before randomization, up to the time of randomization) and for the 12-week treatment period, was the average of the nonmissing BSFS scores from the SBMs reported by the patient during the respective baseline and treatment periods.

    Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison.

    Measured: Baseline and 12-week treatment period

  20. Change From Baseline in Stool Consistency at Week 12

    Stool consistency was measured using the 7-point Bristol Stool Form Scale (BSFS):

    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]

    A patient's BSFS score for the baseline period (14 days before randomization, up to the time of randomization) and at week 12, was the average of the nonmissing BSFS scores from the SBMs reported by the patient during the respective baseline period and during Week 12.

    Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison.

    Measured: Baseline and Week 12

  21. Change From Baseline in 12-week Severity of Straining

    Severity of straining was measured using a 5-point ordinal scale, where of value of 1 is "not at all" and a value of 5 is "an extreme amount." A patient's straining score for baseline was derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization, up to the time of randomization (Visit 3, Day 1). A patient's straining score for the treatment period was the average of the nonmissing straining scores from the SBMs reported by the patient during the 12-week treatment period.

    Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison.

    Measured: Baseline and 12-week treatment period

  22. Change From Baseline in Severity of Straining at Week 12

    Severity of straining was measured using a 5-point ordinal scale, where of value of 1 is "not at all" and a value of 5 is "an extreme amount."

    A patient's straining score for baseline was derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization, up to the time of randomization (Visit 3, Day 1). A patient's straining score at Week 12 was the average of the nonmissing straining scores from the SBMs reported by that patient during analysis Week 12.

    Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison.

    Measured: Baseline and Week 12

  23. 9/12 Week Mild Straining and Diarrhea-free Responder

    A patient was a 9/12 week mild straining and diarrhea-free responder if that patient met the weekly criterion for at least 9 weeks of the 12-week treatment period. A patient was considered to have met the weekly criterion in a given week if that patient had a nonmissing average straining score ≤ 2 (where a value of 1 represents no straining, an a value of 5 represents an extreme amount of straining), and the patient had no diarrhea adverse event (AE) reported for that week.

    Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison.

    Measured: 12-week treatment period

Timeline

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

  1. First posted17 Jul 2012 (estimated)
  2. Study startAug 2012
  3. Primary completionMay 2013
  4. Study completionAug 2013

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
487 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01642914
Sponsor's protocol ID
LIN-MD-04
Status last verified
Mar 2016
First submitted
13 Jul 2012
Last updated
26 Apr 2016
Data monitoring committee
No

Publications

  • Lacy BE, Shea EP, Manuel M, Abel JL, Jiang H, Taylor DCA. Lessons learned: Chronic idiopathic constipation patient experiences with over-the-counter medications. PLoS One. 2021 Jan 11;16(1):e0243318. doi: 10.1371/journal.pone.0243318. eCollection 2021.

    PubMed 33428631

  • Lacy BE, Schey R, Shiff SJ, Lavins BJ, Fox SM, Jia XD, Blakesley RE, Hao X, Cronin JA, Currie MG, Kurtz CB, Johnston JM, Lembo AJ. Linaclotide in Chronic Idiopathic Constipation Patients with Moderate to Severe Abdominal Bloating: A Randomized, Controlled Trial. PLoS One. 2015 Jul 29;10(7):e0134349. doi: 10.1371/journal.pone.0134349. eCollection 2015.

    PubMed 26222318

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Linaclotide 290 micrograms and Linaclotide 145 micrograms in people with Chronic Constipation and Constipation, run by Forest Laboratories at 151 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 8 inclusion and 4 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 26 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 151 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 26 Apr 2016). 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?

9/12 Week Complete Spontaneous Bowel Movement (CSBM) 3+1 Responder (time frame: 12-week treatment period). 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 NCT01642914, 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 26 Apr 2016.

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