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| Name | Class |
|---|---|
| Shire Human Genetic Therapies, Inc. | INDUSTRY |
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The purpose of this study is to evaluate the effects of long acting mesalamine (Lialda) in patients with Post-Infective Irritable Bowel Syndrome (PI-IBS). The investigators will evaluate gastrointestinal symptoms, IBS specific quality of life (IBS-QOL), and plasma cytokines before and after treatment with Lialda.
This study will test long acting mesalamine in the management of PI-IBS. It has the potential to improve QOL and perhaps gastrointestinal symptoms, in patients with PI-IBS. The results of this study, if positive, will provide preliminary data for a large scale clinical trial.
This study will also provide information about plasma cytokines in patients with PI-IBS and whether improvement in symptoms correlates with improvement in plasma cytokines.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Experimental | This arm will include those who are randomized to the placebo |
|
| Mesalamine | Experimental | This arm is for subjects randomized to the study drug, Mesalamine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mesalamine | Drug | 2 1.2g tablets once daily for 8 weeks. Patients randomized 50/50 to either Mesalamine or the Placebo |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Average Overall Bowel Symptom Score (BSS) After an 8 Week Treatment Period | BSS score measured from sum of BSS items of abdominal pain severity, bloating severity, diarrhea severity, constipation severity, and how satisfied are you with bowel habits, and measured on a scale of 0% to 100%, 0 being not severe and 100 being very severe. | Baseline and 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Average Overall IBS Specific Quality of Life Score After an 8 Week Treatment Period. | As measured by the IBS specific Quality of Life questionnaire which consists of 34 items scored on a scale of 0% to 100%, 0 being not at all and 100 being extremely. | Baseline and 8 weeks |
| Change in Average Bowel Frequency After 8-Week Treatment Period |
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Inclusion Criteria:
Inclusion Criteria
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ashok Tuteja | Gastroenterology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Utah | Salt Lake City | Utah | 84132 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | This arm will include those who are randomized to the placebo Placebo: This is an inactive pill |
| FG001 | Mesalamine | This arm is for subjects randomized to the study drug, Mesalamine Mesalamine: 2 1.2g tablets once daily for 8 weeks. Patients randomized 50/50 to either Mesalamine or the Placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | This arm will include those who are randomized to the placebo Placebo: This is an inactive pill |
| BG001 | Mesalamine | This arm is for subjects randomized to the study drug, Mesalamine Mesalamine: 2 1.2g tablets once daily for 8 weeks. Patients randomized 50/50 to either Mesalamine or the Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Average Overall Bowel Symptom Score (BSS) After an 8 Week Treatment Period | BSS score measured from sum of BSS items of abdominal pain severity, bloating severity, diarrhea severity, constipation severity, and how satisfied are you with bowel habits, and measured on a scale of 0% to 100%, 0 being not severe and 100 being very severe. | Not all study participants provided complete outcome results at baseline and 8 weeks. For change in overall BSS, only 25 placebo participants and 28 mesalamine participants provided data for analysis. | Posted | Mean | Standard Error | score on a scale | Baseline and 8 weeks |
|
8 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | This arm will include those who are randomized to the placebo Placebo: This is an inactive pill |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sinusitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ashok Tuteja | University of Utah | 801-581-5679 | Ashok.Tuteja@hsc.utah.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 14, 2019 | Aug 5, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| D003967 | Diarrhea |
| D005759 | Gastroenteritis |
| D015746 | Abdominal Pain |
| D006967 | Hypersensitivity |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D019804 | Mesalamine |
| ID | Term |
|---|---|
| D062368 | meta-Aminobenzoates |
| D062365 | Aminobenzoates |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
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| Placebo | Drug | This is an inactive pill |
|
|
Measured by the participant reported average number of daily bowel movements. |
| Baseline and 8 weeks |
| Change in Average Bowel Consistency Score After an 8 Week Treatment Period. | Measured using the Bristol Stool form scale 1-7, with 1 being the most formed and 7 the least formed. | Baseline and 8 weeks |
| Change in Average Abdominal Pain Score After an 8 Week Treatment Period | Measured on a scale of 0% to 100%, 0 being not severe and 100 being very severe. | Baseline and 8 weeks |
| Change in Average Bloating Score After an 8 Week Treatment Period. | Measured on a scale of 0% to 100%, 0 being not severe and 100 being very severe. | Baseline and 8 weeks |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Mesalamine |
This arm is for subjects randomized to the study drug, Mesalamine Mesalamine: 2 1.2g tablets once daily for 8 weeks. Patients randomized 50/50 to either Mesalamine or the Placebo |
|
|
| Secondary | Change in Average Overall IBS Specific Quality of Life Score After an 8 Week Treatment Period. | As measured by the IBS specific Quality of Life questionnaire which consists of 34 items scored on a scale of 0% to 100%, 0 being not at all and 100 being extremely. | Not all study participants provided complete outcome results at baseline and 8 weeks. For change in average overall IBS specific Quality of Life, only 25 placebo participants and 28 mesalamine participants provided data for analysis. | Posted | Mean | Standard Error | score on a scale | Baseline and 8 weeks |
|
|
|
| Secondary | Change in Average Bowel Frequency After 8-Week Treatment Period | Measured by the participant reported average number of daily bowel movements. | Posted | Mean | Standard Error | Bowel movements per day | Baseline and 8 weeks |
|
|
|
| Secondary | Change in Average Bowel Consistency Score After an 8 Week Treatment Period. | Measured using the Bristol Stool form scale 1-7, with 1 being the most formed and 7 the least formed. | Not all study participants provided complete outcome results at baseline and 8 weeks. For change in average bowel consistency, only 26 placebo participants and 26 mesalamine participants provided data for analysis. | Posted | Mean | Standard Error | score on a scale | Baseline and 8 weeks |
|
|
|
| Secondary | Change in Average Abdominal Pain Score After an 8 Week Treatment Period | Measured on a scale of 0% to 100%, 0 being not severe and 100 being very severe. | Posted | Mean | Standard Error | score on a scale | Baseline and 8 weeks |
|
|
|
| Secondary | Change in Average Bloating Score After an 8 Week Treatment Period. | Measured on a scale of 0% to 100%, 0 being not severe and 100 being very severe. | Not all study participants provided complete outcome results at baseline and 8 weeks. For change in average bloating, only 25 placebo participants and 28 mesalamine participants provided data for analysis. | Posted | Mean | Standard Error | score on a scale | Baseline and 8 weeks |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 10 |
| 30 |
| EG001 | Mesalamine | This arm is for subjects randomized to the study drug, Mesalamine Mesalamine: 2 1.2g tablets once daily for 8 weeks. Patients randomized 50/50 to either Mesalamine or the Placebo | 0 | 31 | 0 | 31 | 16 | 31 |
| Upper respiratory infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Motion Sickness | Ear and labyrinth disorders | Systematic Assessment |
|
| light headed/dizziness | General disorders | Systematic Assessment |
|
| Bloating | Gastrointestinal disorders | Systematic Assessment |
|
| Swelling | General disorders | Systematic Assessment |
|
| Weight Gain | Metabolism and nutrition disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Fever | General disorders | Systematic Assessment |
|
| Sharp pain | General disorders | Systematic Assessment | Under left rib cage |
|
| Abdominal Pain | General disorders | Systematic Assessment |
|
| Increased bowel movement | Gastrointestinal disorders | Systematic Assessment |
|
| Nausea | General disorders | Systematic Assessment |
|
| Heartburn | Gastrointestinal disorders | Systematic Assessment |
|
| Elevated Liver Function Tests | Hepatobiliary disorders | Systematic Assessment |
|
| Chest Pain | General disorders | Systematic Assessment |
|
| Gas | Gastrointestinal disorders | Systematic Assessment |
|
| Reflux | Gastrointestinal disorders | Systematic Assessment |
|
| Hematochezia | Gastrointestinal disorders | Systematic Assessment |
|
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| D004066 | Digestive System Diseases |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D007154 | Immune System Diseases |
| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000636 | Aminosalicylic Acids |
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D006880 | Hydroxy Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010636 | Phenols |