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

This study has been completed.
Sponsor:
Collaborator:
Ironwood Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT01642914
First received: July 13, 2012
Last updated: March 24, 2016
Last verified: March 2016
  Purpose
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.

Condition Intervention Phase
Chronic Constipation
Constipation
Drug: Linaclotide 290 micrograms
Drug: Linaclotide 145 micrograms
Drug: Matching placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Forest Laboratories:

Primary Outcome Measures:
  • 9/12 Week Complete Spontaneous Bowel Movement (CSBM) 3+1 Responder [ Time Frame: 12-week treatment period ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 9/12 Week Complete Spontaneous Bowel Movement (CSBM) 3+1 Responder [ Time Frame: 12-week treatment period ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in 12-Week Abdominal Bloating [ Time Frame: Baseline and 12-week treatment period ] [ Designated as safety issue: No ]
    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.

  • Percent Change From Baseline in 12-week Abdominal Bloating [ Time Frame: Baseline and 12-week treatment period ] [ Designated as safety issue: No ]
    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.

  • Percent Change From Baseline in Abdominal Bloating at Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    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.

  • 6/12 Week Abdominal Bloating 30% Responder [ Time Frame: 12-week treatment period ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in 12-week CSBM Frequency Rate [ Time Frame: Baseline and 12-week treatment period ] [ Designated as safety issue: No ]

    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.


  • Change From Baseline in CSBM Frequency Rate at Week 1. [ Time Frame: Baseline and Week 1 ] [ Designated as safety issue: No ]

    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.


  • Change From Baseline in CSBM Frequency Rate at Week 4. [ Time Frame: Baseline and Week 4 ] [ Designated as safety issue: No ]

    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.


  • Change From Baseline in CSBM Frequency Rate at Week 8 [ Time Frame: Baseline and Week 8 ] [ Designated as safety issue: No ]

    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.


  • Change From Baseline in CSBM Frequency Rate at Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]

    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.


  • Change From Baseline in 12-Week SBM Frequency Rate [ Time Frame: 12-week treatment period ] [ Designated as safety issue: No ]

    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.


  • Change From Baseline in SBM Frequency Rate at Week 1 [ Time Frame: Baseline and Week 1 ] [ Designated as safety issue: No ]

    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.


  • Change From Baseline in SBM Frequency Rate at Week 4 [ Time Frame: Baseline and Week 4 ] [ Designated as safety issue: No ]

    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.


  • Change From Baseline in SBM Frequency Rate at Week 8 [ Time Frame: Baseline and Week 8 ] [ Designated as safety issue: No ]

    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.


  • Change From Baseline in SBM Frequency Rate at Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]

    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.


  • Change From Baseline in the Number of Days With a Spontaneous Bowel Movement (SBM) [ Time Frame: Baseline and 12-week treatment period ] [ Designated as safety issue: No ]

    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.


  • SBM Within 24 Hours After the First Dose of Investigational Product [ Time Frame: 24 hours from first dose of investigational product (Day 1) ] [ Designated as safety issue: No ]

    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.


  • Time to Spontaneous Bowel Movement (SBM) After the First Dose of Investigational Product [ Time Frame: 12-week treatment period ] [ Designated as safety issue: No ]

    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.


  • Change From Baseline in 12-week Stool Consistency [ Time Frame: Baseline and 12-week treatment period ] [ Designated as safety issue: No ]

    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.


  • Change From Baseline in Stool Consistency at Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]

    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.


  • Change From Baseline in 12-week Severity of Straining [ Time Frame: Baseline and 12-week treatment period ] [ Designated as safety issue: No ]

    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.


  • Change From Baseline in Severity of Straining at Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]

    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.


  • 9/12 Week Mild Straining and Diarrhea-free Responder [ Time Frame: 12-week treatment period ] [ Designated as safety issue: No ]

    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.



Enrollment: 487
Study Start Date: August 2012
Study Completion Date: August 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Linaclotide 290 micrograms
Linaclotide 290 micrograms
Drug: Linaclotide 290 micrograms
oral capsule, taken once daily each morning at least 30 minutes before breakfast
Experimental: Linaclotide 145 Micrograms
Linaclotide 145 micrograms
Drug: Linaclotide 145 micrograms
oral capsule, taken once daily each morning at least 30 minutes before breakfast
Placebo Comparator: Placebo
Matching placebo
Drug: Matching placebo
oral capsule, taken once daily each morning at least 30 minutes before breakfast

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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:

    1. Straining during more than 25% of BMs
    2. Lumpy or hard stools during more than 25% of BMs
    3. 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)

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01642914

  Hide Study Locations
Locations
United States, Arizona
Forest Investigative Site 020
Chandler, Arizona, United States, 85224
Forest Investigative Site 102
Chandler, Arizona, United States, 85224
Forest Investigative Site 149
Glendale, Arizona, United States, 85308
Forest Investigative Site 126
Goodyear, Arizona, United States, 85395
Forest Investigative Site 018
Phoenix, Arizona, United States, 85018
Forest Investigative Site 061
Phoenix, Arizona, United States, 85020
Forest Investigative Site 022
Scottsdale, Arizona, United States, 85251
Forest Investigative Site 079
Tucson, Arizona, United States, 85704
Forest Investigative Site 071
Tucson, Arizona, United States, 85712
United States, Arkansas
Forest Investigative Site 135
North Little Rock, Arkansas, United States, 72117
United States, California
Forest Investigative Site 106
Anaheim, California, United States, 92801
Forest Investigative Site 104
Laguna Hills, California, United States, 92653
Forest Investigative Site 066
Mission Hills, California, United States, 91345
Forest Investigative Site 095
San Carlos, California, United States, 94070
Forest Investigative Site 009
San Diego, California, United States, 92108
Forest Investigative Site 151
Santa Monica, California, United States, 90404
Forest Investigative Site 010
Westlake Village, California, United States, 91361
United States, Colorado
Forest Investigative Site 012
Boulder, Colorado, United States, 80304
Forest Investigative Site 041
Colorado Springs, Colorado, United States, 80904
Forest Investigative Site 045
Colorado Springs, Colorado, United States, 80907
Forest Investigative Site 060
Longmont, Colorado, United States, 80501
United States, Connecticut
Forest Investigative Site 007
Bristol, Connecticut, United States, 06010
Forest Investigative Site 153
Waterbury, Connecticut, United States, 06708
United States, Florida
Forest Investigative Site 091
Boynton Beach, Florida, United States, 33426
Forest Investigative Site 047
Bradenton, Florida, United States, 34208
Forest Investigative Site 042
Brooksville, Florida, United States, 34601
Forest Investigative Site 133
Coral Gables, Florida, United States, 33134
Forest Investigative Site 131
DeLand, Florida, United States, 32720
Forest Investigative Site 051
Ft. Myers, Florida, United States, 33916
Forest Investigative Site 137
Inverness, Florida, United States, 34452
Forest Investigative Site 114
Jacksonville, Florida, United States, 32205
Forest Investigative Site 004
Jupiter, Florida, United States, 33458
Forest Investigative Site 016
Kissimmee, Florida, United States, 34741
Forest Investigative Site 097
Lauderdale Lakes, Florida, United States, 33319
Forest Investigative Site 003
Miami, Florida, United States, 33143
Forest Investigative Site 002
Miami, Florida, United States, 33183
Forest Investigative Site 130
New Smyrna Beach, Florida, United States, 32168
Forest Investigative Site 040
Ocala, Florida, United States, 34471
Forest Investigative Site 083
Orlando, Florida, United States, 32806
Forest Investigative Site 150
Oviedo, Florida, United States, 32765
Forest Investigative Site 132
Port Orange, Florida, United States, 32129
Forest Investigative Site 127
Seminole, Florida, United States, 33777
Forest Investigative Site 087
St. Petersburg, Florida, United States, 33709
Forest Investigative Site 064
Tampa, Florida, United States, 33606
Forest Investigative Site 115
Zephyrhills, Florida, United States, 33542
United States, Georgia
Forest Investigative Site 021
Marietta, Georgia, United States, 30060
Forest Investigative Site 011
Marietta, Georgia, United States, 30067
Forest Investigative Site 109
Sandy Springs, Georgia, United States, 30328
Forest Investigative Site 037
Stockbridge, Georgia, United States, 30281
Forest Investigative Site 023
Woodstock, Georgia, United States, 30189
United States, Idaho
Forest Investigative Site 015
Idaho Falls, Idaho, United States, 83404
United States, Illinois
Forest Investigative Site 122
Peoria, Illinois, United States, 61602
Forest Investigative Site 043
Rockford, Illinois, United States, 61107
United States, Indiana
Forest Investigative Site 107
Anderson, Indiana, United States, 46011
United States, Iowa
Forest Investigative Site 117
Clive, Iowa, United States, 50325
Forest Investigative Site 146
Clive, Iowa, United States, 50325
Forest Investigative Site 143
Davenport, Iowa, United States, 52807
Forest Investigative Site 055
Iowa City, Iowa, United States, 52242
United States, Kansas
Forest Investigative Site 028
Newton, Kansas, United States, 67114
Forest Investigative Site 112
Overland Park, Kansas, United States, 66215
Forest Investigative Site 034
Wichita, Kansas, United States, 67205
Forest Investigative Site 032
Wichita, Kansas, United States, 67207
United States, Kentucky
Forest Investigative Site 128
Lexington, Kentucky, United States, 40509
Forest Investigative Site 134
Madisonville, Kentucky, United States, 42431
United States, Louisiana
Forest Investigative Site 121
Baton Rouge, Louisiana, United States, 70809
Forest Investigative Site 124
Metairie, Louisiana, United States, 70006
Forest Investigative Site 101
Monroe, Louisiana, United States, 71201
Forest Investigative Site 058
Shreveport, Louisiana, United States, 71101
Forest Investigative Site 099
Shreveport, Louisiana, United States, 71103
United States, Maryland
Forest Investigative Site 062
Baltimore, Maryland, United States, 21215
Forest Investigative Site 008
Chevy Chase, Maryland, United States, 20815
Forest Investigative Site 014
Hagerstown, Maryland, United States, 21742
Forest Investigative Site 024
Towson, Maryland, United States, 21286
United States, Massachusetts
Forest Investigative Site 006
Boston, Massachusetts, United States, 02135
United States, Michigan
Forest Investigative Site 070
Chesterfield, Michigan, United States, 48047
Forest Investigative Site 145
Traverse City, Michigan, United States, 49684
United States, Mississippi
Forest Investigative Site 141
Jackson, Mississippi, United States, 39202
United States, Nebraska
Forest Investigative Site 077
Fremont, Nebraska, United States, 68025
Forest Investigative Site 048
Omaha, Nebraska, United States, 68134
United States, Nevada
Forest Investigative Site 052
Henderson, Nevada, United States, 89014
Forest Investigative Site 080
Las Vegas, Nevada, United States, 89121
United States, New Jersey
Forest Investigative Site 036
Clifton, New Jersey, United States, 07012
Forest Investigative Site 088
Marlton, New Jersey, United States, 08053
Forest Investigative Site 033
Vineland, New Jersey, United States, 08360
United States, New Mexico
Forest Investigative Site 063
Albuquerque, New Mexico, United States, 87106
Forest Investigative Site 093
Albuquerque, New Mexico, United States, 87108
United States, New York
Forest Investigative Site 044
Brooklyn, New York, United States, 11206
Forest Investigative Site 017
Great Neck, New York, United States, 11021
United States, North Carolina
Forest Investigative Site 142
Asheboro, North Carolina, United States, 27203
Forest Investigative Site 094
Asheville, North Carolina, United States, 28801
Forest Investigative Site 075
Boone, North Carolina, United States, 28607
Forest Investigative Site 123
Chapel Hill, North Carolina, United States, 27599-7080
Forest Investigative Site 140
Davidson, North Carolina, United States, 28036
Forest Investigative Site 039
Fayetteville, North Carolina, United States, 28304
Forest Investigative Site 031
Greensboro, North Carolina, United States, 27403
Forest Investigative Site 029
Greensboro, North Carolina, United States, 27408
Forest Investigative Site 078
Greensboro, North Carolina, United States, 27408
Forest Investigative Site 084
Harrisburg, North Carolina, United States, 28075
Forest Investigative Site 073
Hickory, North Carolina, United States, 28601
Forest Investigative Site 050
Hickory, North Carolina, United States, 28602
Forest Investigative Site 139
High Point, North Carolina, United States, 27262
Forest Investigative Site 027
Raleigh, North Carolina, United States, 27612
Forest Investigative Site 119
Statesville, North Carolina, United States, 28625
Forest Investigative Site 089
Wilmington, North Carolina, United States, 28401
Forest Investigative Site 074
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Forest Investigative Site 025
Cincinnati, Ohio, United States, 45242
Forest Investigative Site 120
Cincinnati, Ohio, United States, 45249
Forest Investigative Site 056
Cleveland, Ohio, United States, 44122
Forest Investigative Site 026
Columbus, Ohio, United States, 43215
Forest Investigative Site 098
Dayton, Ohio, United States, 45415
Forest Investigative Site 090
Dayton, Ohio, United States, 45432
Forest Investigative Site 085
Mentor, Ohio, United States, 44060
Forest Investigative Site 068
Wadsworth, Ohio, United States, 44281
United States, Oklahoma
Forest Investigative Site 118
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
Forest Investigative Site 081
Levittown, Pennsylvania, United States, 19056
Forest Investigative Site 001
Pittsburgh, Pennsylvania, United States, 15206
Forest Investigative Site 110
Reading, Pennsylvania, United States, 19606
United States, South Carolina
Forest Investigative Site 116
Greer, South Carolina, United States, 29650
Forest Investigative Site 046
Simpsonville, South Carolina, United States, 29681
United States, South Dakota
Forest Investigative Site 092
Dakota Dunes, South Dakota, United States, 57049
United States, Tennessee
Forest Investigative Site 129
Chattanooga, Tennessee, United States, 37421
Forest Investigative Site 138
Kingsport, Tennessee, United States, 37660
United States, Texas
Forest Investigative Site 125
Austin, Texas, United States, 78756
Forest Investigative Site 035
Dallas, Texas, United States, 75231
Forest Investigative Site 005
Dallas, Texas, United States, 75234
Forest Investigative Site 111
Fort Worth, Texas, United States, 76135
Forest Investigative Site 100
Houston, Texas, United States, 77034
Forest Investigative Site 067
Katy, Texas, United States, 77450
Forest Investigative Site 049
Pasadena, Texas, United States, 77505
Forest Investigative Site 030
San Antonio, Texas, United States, 78209
Forest Investigative Site 076
San Antonio, Texas, United States, 78229
Forest Investigative Site 065
Sugarland, Texas, United States, 77479
United States, Utah
Forest Investigative Site 019
Ogden, Utah, United States, 84405
Forest Investigative Site 105
Salt Lake City, Utah, United States, 84107
Forest Investigative Site 113
Sandy, Utah, United States, 84094
United States, Virginia
Forest Investigative Site 053
Charlottesville, Virginia, United States, 22911
Forest Investigative Site 108
Chesapeake, Virginia, United States, 23320
Forest Investigative Site 136
Chesapeake, Virginia, United States, 23320
Forest Investigative Site 148
Christiansburg, Virginia, United States, 24073
Forest Investigative Site 072
Lynchburg, Virginia, United States, 24502
Forest Investigative Site 069
Newport News, Virginia, United States, 23606
Forest Investigative Site 013
Norfolk, Virginia, United States, 23502
Forest Investigative Site 038
Richmond, Virginia, United States, 23294
United States, Washington
Forest Investigative Site 103
Spokane, Washington, United States, 99208
United States, Wisconsin
Forest Investigative Site 082
La Crosse, Wisconsin, United States, 54601
Forest Investigative Site 096
Milwaukee, Wisconsin, United States, 53215
Canada, Ontario
Forest Investigative Site 059
Sarnia, Ontario, Canada, N7T 4X3
Forest Investigative Site 054
Sudbury, Ontario, Canada, P3E 1H5
Forest Investigative Site 086
Toronto, Ontario, Canada, M4S 1Y2
Forest Investigative Site 147
Toronto, Ontario, Canada, M9W 4L6
Forest Investigative Site 152
Vaughan, Ontario, Canada, L4L 4Y7
Sponsors and Collaborators
Forest Laboratories
Ironwood Pharmaceuticals, Inc.
Investigators
Study Director: Steven Shiff, MD Forest Laboratories
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT01642914     History of Changes
Other Study ID Numbers: LIN-MD-04 
Study First Received: July 13, 2012
Results First Received: May 29, 2014
Last Updated: March 24, 2016
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by Forest Laboratories:
Chronic Constipation
Abdominal Bloating
Linaclotide

Additional relevant MeSH terms:
Constipation
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on August 24, 2016