Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to determine the daily dose of mesalamine granules that will provide adequate relief from symptoms of IBS with diarrhea.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| Mesalamine Granules 750 mg | Experimental |
| |
| Mesalamine Granules 1500 mg | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | placebo capsules once daily for 12 weeks |
| |
| Mesalamine Granules 750 mg |
| Measure | Description | Time Frame |
|---|---|---|
| The Number of Months That Subjects Are Monthly Responders in Both IBS-related Abdominal Pain AND Stool Consistency During the Entire Three Months. | A weekly responder in abdominal pain is defined as a ≥30% improvement from baseline in the weekly average abdominal pain score on a 10-point scale (0=no pain - 10= worst possible pain). A weekly responder in stool consistency is defined as ≥50% reduction in the number of days in a week with stool consistency of Type 6 or 7 compared with baseline using the Bristol Stool Scale. Monthly responders are subjects who are weekly responders in both abdominal pain and stool consistency for at least two out of four weeks. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Subjects Who Are Monthly Responders in Both Abdominal Pain and Stool Consistency for at Least 2 Months During the 3-month Treatment Period | A weekly responder in abdominal pain is defined as a ≥30% improvement from baseline in the weekly average abdominal pain score on a 10-point scale (0=no pain - 10= worst possible pain). A weekly responder in stool consistency is defined as ≥50% reduction in the number of days in a week with stool consistency of Type 6 or 7 compared with baseline using the Bristol Stool Scale. Monthly responders are subjects who are weekly responders in both abdominal pain and stool consistency for at least two out of four weeks. |
Not provided
Inclusion Criteria:
Male or non-pregnant, non-lactating female subjects Diagnosed with IBS confirmed by the Rome III criteria
Meet the following IBS symptom scores in all categories during the diary eligibility period:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sherwood | Arkansas | 72120 | United States | |||
Failure to meet baseline IBS symptom scores (based on diary responses)
Study Period: 09Aug2010 to 16Aug2011. 20 Study Sites; US Only. Study locations were a variety including: Gastrointestinal, Family Practice, Medical Centers and/or University setting
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Mesalamine Granules 1500 mg | Mesalamine Granules 1500 mg : 1500 mg mesalamine granules once daily for 12 weeks |
| FG001 | Mesalamine Granules 750 mg | Mesalamine Granules 750 mg : 750 mg mesalamine granules once daily for 12 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
750 mg mesalamine granules once daily for 12 weeks |
|
| Mesalamine Granules 1500 mg | Drug | 1500 mg mesalamine granules once daily for 12 weeks |
|
| 3 months |
| Anaheim |
| California |
| 92801 |
| United States |
| Sacramento | California | 95831 | United States |
| San Diego | California | 92108 | United States |
| San Francisco | California | 94115 | United States |
| Bristol | Connecticut | 06010 | United States |
| Boynton Beach | Florida | 33426 | United States |
| St. Petersburg | Florida | 33709 | United States |
| Macon | Georgia | 31201 | United States |
| Shreveport | Louisiana | 71103 | United States |
| Ann Arbor | Michigan | 48109 | United States |
| Wyoming | Michigan | 49519 | United States |
| Mexico | Missouri | 65265 | United States |
| St Louis | Missouri | 63141 | United States |
| Albuquerque | New Mexico | 87102 | United States |
| New York | New York | 10016 | United States |
| Greensboro | North Carolina | 27408 | United States |
| Plano | Texas | 75075 | United States |
| Ogden | Utah | 84405 | United States |
| Lynchburg | Virginia | 24502 | United States |
| FG002 | Placebo | Placebo : placebo capsules once daily for 12 weeks |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Mesalamine Granules 1500 mg | Mesalamine Granules 1500 mg : 1500 mg mesalamine granules once daily for 12 weeks |
| BG001 | Mesalamine Granules 750 mg | Mesalamine Granules 750 mg : 750 mg mesalamine granules once daily for 12 weeks |
| BG002 | Placebo | Placebo : placebo capsules once daily for 12 weeks |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Proportion of Subjects Who Are Monthly Responders in Both Abdominal Pain and Stool Consistency for at Least 2 Months During the 3-month Treatment Period | A weekly responder in abdominal pain is defined as a ≥30% improvement from baseline in the weekly average abdominal pain score on a 10-point scale (0=no pain - 10= worst possible pain). A weekly responder in stool consistency is defined as ≥50% reduction in the number of days in a week with stool consistency of Type 6 or 7 compared with baseline using the Bristol Stool Scale. Monthly responders are subjects who are weekly responders in both abdominal pain and stool consistency for at least two out of four weeks. | Intent to Treat Population included all randomized subjects who ingested at least one dose of study drug. Analysis of study data was based on observed cases, missing data remained missing. | Posted | Number | participants | 3 months |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | The Number of Months That Subjects Are Monthly Responders in Both IBS-related Abdominal Pain AND Stool Consistency During the Entire Three Months. | A weekly responder in abdominal pain is defined as a ≥30% improvement from baseline in the weekly average abdominal pain score on a 10-point scale (0=no pain - 10= worst possible pain). A weekly responder in stool consistency is defined as ≥50% reduction in the number of days in a week with stool consistency of Type 6 or 7 compared with baseline using the Bristol Stool Scale. Monthly responders are subjects who are weekly responders in both abdominal pain and stool consistency for at least two out of four weeks. | Intent to Treat Population included all randomized subjects who ingested at least one dose of study drug. Analysis of study data was based on observed cases, missing data remained missing. | Posted | Number | participants | 3 months |
|
Study Duration; Reported adverse events (AEs) include AEs observed over the 48 weeks of treatment.
SAEs will be followed for up to 30 days post treatment
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Mesalamine Granules 1500 mg | Mesalamine Granules 1500 mg : 1500 mg mesalamine granules once daily for 12 weeks | 0 | 51 | 15 | 51 | ||
| EG001 | Mesalamine Granules 750 mg | Mesalamine Granules 750 mg : 750 mg mesalamine granules once daily for 12 weeks | 1 | 47 | 9 | 47 | ||
| EG002 | Placebo | Placebo : placebo capsules once daily for 12 weeks | 0 | 50 | 7 | 50 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Incision Site Abscess | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Intervertebral disc degeneration | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal distension | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 13.0 | Non-systematic Assessment |
|
INVESTIGATOR shall not publish the results of the Study conducted at the INSTITUTION, unless they (i) obtain the prior written consent of SALIX for the publication; or (ii) withhold any publication for a period of two (2) years following the Completion of the Study by all participating institutions and investigators
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President of Clinical Operations | Salix Pharmaceuticals, Inc. | 919-862-1000 | enoch.bortey@salix.com |
| ID | Term |
|---|---|
| D003967 | Diarrhea |
| D043183 | Irritable Bowel Syndrome |
| D015746 | Abdominal Pain |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Odds Ratio (OR) |
| 1.267 |
| 2-Sided |
| 95 |
| 0.515 |
| 3.115 |
| Superiority or Other (legacy) |
|
|
|