Irritable Bowel Syndrome With Constipation Clinical Trial
Official title:
A Randomized, Multicenter, Double-blind, Placebo-controlled, Dose-range-finding, Parallel-design, Phase 2 Trial of Oral Linaclotide Acetate Administered to Patients With Irritable Bowel Syndrome With Constipation
The purpose of this study is to determine the safety, efficacy, and dose response of a range of oral doses of linaclotide administered to patients meeting criteria for IBS-C.
Status | Completed |
Enrollment | 420 |
Est. completion date | April 2008 |
Est. primary completion date | February 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Must not be pregnant or breastfeeding and agree to use birth control; - Completion of a negative colonoscopy as per American Gastroenterology Association (AGA) criteria and no clinically-significant laboratory or physical examination findings; - Meets protocol-defined criteria for IBS-C, including stool frequency, straining, stool consistency, abdominal pain, and abdominal discomfort criteria; - Demonstrates English fluency and has access to a touch-tone telephone. Exclusion Criteria: - Recent history of mushy or watery stools; - Various medical conditions, medical histories, or family medical histories that would not make the patient a good candidate for the study; - Clinically-significant alarm symptoms; - Secondary causes of constipation or evacuation disorders; - Surgery to the gastrointestinal tract; - Usage of prohibited medications. |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | Microbia Investigational Site | Abbortsford | British Columbia |
Canada | Microbia Investigational Site | Guelph | Ontario |
Canada | Microbia Investigational Site | Milton | Ontario |
Canada | Microbia Investigational Site | Saskatoon | Saskatchewan |
Canada | Microbia Investigational Site | Toronto | Ontario |
Canada | Microbia Investigational Site | Winnipeg | Manitoba |
United States | Microbia Investigational Site | Anaheim | California |
United States | Microbia Investigational Site | Anderson | South Carolina |
United States | Microbia Investigational Site | Ann Arbor | Michigan |
United States | Microbia Investigational Site | Annapolis | Maryland |
United States | Microbia Investigational Site | Asheville | North Carolina |
United States | Microbia Investigational Site | Baton Rouge | Louisiana |
United States | Microbia Investigational Site | Beaumont | Texas |
United States | Microbia Investigational Site | Blackwood | New Jersey |
United States | Microbia Investigational Site | Boynton Beach | Florida |
United States | Microbia Investigational Site | Bristol | Connecticut |
United States | Microbia Investigational Site | Bristol | Tennessee |
United States | Microbia Investigational Site | Chandler | Arizona |
United States | Microbia Investigational Site | Chapel Hill | North Carolina |
United States | Microbia Investigational Site | Charleston | West Virginia |
United States | Microbia Investigational Site | Chesapeake | Virginia |
United States | Microbia Investigational Site | Cincinnati | Ohio |
United States | Microbia Investigational Site | Cleveland | Ohio |
United States | Microbia Investigational Site | Clive | Iowa |
United States | Microbia Investigational Site | Corsicana | Texas |
United States | Microbia Investigational Site | Davenport | Iowa |
United States | Microbia Investigational Site | Dayton | Ohio |
United States | Microbia Investigational Site | Dunedin | Florida |
United States | Microbia Investigational Site | El Paso | Texas |
United States | Microbia Investigational Site | Elkin | North Carolina |
United States | Microbia Investigational Site | Fall River | Massachusetts |
United States | Microbia Investigational Site | Garden Grove | California |
United States | Microbia Investigational Site | Germantown | Tennessee |
United States | Microbia Investigational Site | Great Neck | New York |
United States | Microbia Investigational Site | Greensboro | North Carolina |
United States | Microbia Investigational Site | Harrisburg | North Carolina |
United States | Microbia Investigational Site | Henderson | Nevada |
United States | Microbia Investigational Site | Hickory | North Carolina |
United States | Microbia Investigational Site | Huntsville | Alabama |
United States | Microbia Investigational Site | Jackson | Tennessee |
United States | Microbia Investigational Site | Kingsport | Tennessee |
United States | Microbia Investigational Site | LaCrosse | Wisconsin |
United States | Microbia Investigational Site | Lakewood | Washington |
United States | Microbia Investigational Site | Largo | Florida |
United States | Microbia Investigational Site | Las Vegas | Nevada |
United States | Microbia Investigational Site | Levittown | Pennsylvania |
United States | Microbia Investigational Site | Libertyville | Illinois |
United States | Microbia Investigational Site | Lynchburg | Virginia |
United States | Microbia Investigational Site | Medford | Oregon |
United States | Microbia Investigational Site | Mission | Kansas |
United States | Microbia Investigational Site | Missoula | Montana |
United States | Microbia Investigational Site | Monroe | Louisiana |
United States | Microbia Investigational Site | Mt. Pleasant | South Carolina |
United States | Microbia Investigational Site | Ocala | Florida |
United States | Microbia Investigational Site | Ogden | Utah |
United States | Microbia Investigational Site | Oklahoma City | Oklahoma |
United States | Microbia Investigational Site | Olympia | Washington |
United States | Microbia Investigational Site | Peoria | Illinois |
United States | Microbia Investigational Site | Pittsburgh | Pennsylvania |
United States | Microbia Investigational Site | Pittsford | New York |
United States | Microbia Investigational Site | Port Orange | Florida |
United States | Microbia Investigational Site | Raleigh | North Carolina |
United States | Microbia Investigational Site | Reading | Pennsylvania |
United States | Microbia Investigational Site | Richmond | Virginia |
United States | Microbia Investigational Site | Sacramento | California |
United States | Microbia Investigational Site | San Antonio | Texas |
United States | Microbia Investigational Site | San Diego | California |
United States | Microbia Investigational Site | Sellersville | Pennsylvania |
United States | Microbia Investigational Site | Shawnee | Kansas |
United States | Microbia Investigational Site | Sherwood | Arkansas |
United States | Microbia Investigational Site | Silver Spring | Maryland |
United States | Microbia Investigational Site | Simpsonville | South Carolina |
United States | Microbia Investigational Site | St. Louis | Missouri |
United States | Microbia Investigational Site | Statesville | North Carolina |
United States | Microbia Investigational Site | Stockbridge | Georgia |
United States | Microbia Investigational Site | Stuart | Florida |
United States | Microbia Investigational Site | Summerville | South Carolina |
United States | Microbia Investigational Site | Sylvania | Ohio |
United States | Microbia Investigational Site | Tampa | Florida |
United States | Microbia Investigational Site | Tulsa | Oklahoma |
United States | Microbia Investigational Site | Tuscon | Arizona |
United States | Microbia Investigational Site | Vancouver | Washington |
United States | Microbia Investigational Site | West Monroe | Louisiana |
United States | Microbia Investigational Site | Winston-Salem | North Carolina |
United States | Microbia Investigational Site | Yukon | Oklahoma |
Lead Sponsor | Collaborator |
---|---|
Ironwood Pharmaceuticals, Inc. |
United States, Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change From Baseline in the Weekly Normalized Complete Spontaneous Bowel Movement (CSBM) Rate During Weeks 1 Through 12 of the Treatment Period | The change in the weekly normalized CSBM Rate during Weeks 1 through 12 of the Treatment Period from the weekly normalized CSBM Rate obtained during the Pretreatment Period. The CSBM rate was normalized based on the number of CSBMs occurring in that week, adjusting for differences in the duration of the week and black-out periods (time not covered due to a missed IVRS call) versus 7x24 hours. |
Change from Baseline to Week 12 | No |
Secondary | CSBM 75% Responder for the Treatment Period (Based on the Normalized Rate) | For each week of the Treatment and Posttreatment Periods, a patient was considered a CSBM Responder if for that week the patient 1) completed = 4 days of IVRS questions, 2) had a CSBM rate of = 3 for the week, and 3) had an increase in CSBM rate of = 1 from the baseline weekly CSBM rate. | Change from Baseline to Week 12 | No |
Secondary | Change From Baseline in the Weekly Normalized SBM Rate for the Treatment Period | SBMs were measured daily during the treatment period by patient calls to the IVRS. | Change from Baseline to Week 12 | No |
Secondary | Change From Baseline in Stool Consistency (7-point Ordinal BSFS) for the Treatment Period | Stool consistency analyses were performed using the 7-point Bristol Stool Form Scale (BSFS), whereby a score of 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; and 7 = watery, no solid pieces (entirely liquid). | Change from Baseline to Week 12 | No |
Secondary | Change From Baseline in Straining (5-point Ordinal Scale) for the Treatment Period | Straining was assessed using a 5-point ordinal scale, whereby a score of 1 = not at all, 2 = a little bit, 3 = a moderate amount, 4 = a great deal, and 5 = an extreme amount. | Change from Baseline to Week 12 | No |
Secondary | Change From Baseline in Degree of Relief of Irritable Bowel Syndrome (IBS) Symptoms (7-point Balanced Scale) for the Treatment Period | Patients provided a weekly assessment of Degree of Relief of IBS Symptoms using a 7-point balanced scale (1=completely relieved, 2=considerably relieved, 3=somewhat relieved, 4=unchanged, 5=somewhat worse, 6=considerably worse, 7=as bad as I can imagine). | Change from Baseline to Week 12 | No |
Secondary | Change From Baseline in Abdominal Pain (5-point Ordinal Scale) for the Treatment Period | During the study, patients provided their self assessment of abdominal pain using a 5-point ordinal scale (1=none, 2=mild, 3=moderate, 4=severe, 5=very severe | Change from Baseline to Week 12 | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT00730171 -
An Open-label, Long-term Safety Study of Linaclotide in Patients With Chronic Constipation or Irritable Bowel Syndrome With Constipation
|
Phase 3 | |
Completed |
NCT00215566 -
A Study to Evaluate the Safety, Tolerability and Pharmacodynamics of DDP733 for IBS-c
|
Phase 2 | |
Completed |
NCT00765999 -
An Open-Label, Long-Term Safety Study of Linaclotide in Patients With Chronic Constipation or Irritable Bowel Syndrome With Constipation
|
Phase 3 | |
Completed |
NCT02559206 -
Trial of Linaclotide in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)
|
Phase 2 | |
Recruiting |
NCT05646186 -
Personalized Dietary Intervention Based on Microbiome Analysis vs FODMAP Diet for Irritable Bowel Syndrome
|
N/A | |
Completed |
NCT04026113 -
Linaclotide Safety and Efficacy in Pediatric Participants, 6 to 17 Years of Age, With Irritable Bowel Syndrome With Constipation (IBS-C) or Functional Constipation (FC)
|
Phase 3 | |
Recruiting |
NCT05519683 -
Home Transcutaneous Electrical Acustimulation (TEA)
|
Phase 2/Phase 3 | |
Active, not recruiting |
NCT04166058 -
Long-term Safety of Linaclotide in Pediatric Participants With FC or IBS-C
|
Phase 3 | |
Completed |
NCT05164861 -
Safety and Efficacy of Non-alcoholic Beverage Based on Kombucha in Patients With Constipations
|
N/A | |
Completed |
NCT04968652 -
IBS-C Questionnaire Study
|
||
Terminated |
NCT02559817 -
A Safety and Efficacy Study of a Range of Linaclotide Doses Administered Orally to Children Ages 7-17 Years, With Irritable Bowel Syndrome With Constipation
|
Phase 2 | |
Completed |
NCT02590432 -
An Open-Label, Long-term Study to Assess the Immunogenicity of LINZESS® (Linaclotide) Administered Orally to Adult Participants With Irritable Bowel Syndrome With Constipation or Chronic Idiopathic Constipation
|
Phase 4 | |
Recruiting |
NCT05796388 -
A Study of Virtual Reality and Linaclotide for IBS-C
|
N/A | |
Completed |
NCT00380250 -
Efficacy and Safety of Lubiprostone in Patients With Irritable Bowel Syndrome With Constipation
|
Phase 3 | |
Completed |
NCT04647045 -
An Evaluation of Cultured Milk Drink on Immune Status of Patients With Irritable Bowel Syndrome: Constipation Predominant
|
N/A | |
Completed |
NCT03054506 -
The Effect of CSP01 on Chronic Idiopathic Constipation and Irritable Bowel Syndrome With Constipation
|
N/A | |
Recruiting |
NCT04214470 -
A Non-Interventional Pilot Study to Explore the Role of Gut Flora in IBS
|
||
Not yet recruiting |
NCT06219707 -
Electro-acupuncture for Irritable Bowel Syndrome With Constipation
|
N/A | |
Recruiting |
NCT03596905 -
Efficacy and Safety of Plecanatide in Children 6 to <18 Years of Age With Irritable Bowel Syndrome With Constipation (IBS-C)
|
Phase 2 | |
Completed |
NCT04132804 -
Effect of Tai Chi as Treatment for IBS-C
|
N/A |