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Difficulty in enrolling subjects
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Will Ranolazine improve bowel function and abdominal pain in human subjects with IBS-D?
This is a randomized double-blind placebo-controlled pilot study that will use validated bowel questionnaires to evaluate the effects of ranolazine administered orally twice daily in patients with diarrhea predominant IBS (IBS-D). The study will consist of a 2 week run in period, followed by 4 weeks of treatment period with oral ranolazine 1000 mg twice daily. Primary endpoint of the study will be the average Bowel Symptom Scale (BSS) scores for diarrhea and adequate relief of IBS pain and discomfort are secondary end points.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ranolazine | Active Comparator | tablet, 1000 mg twice daily for four weeks |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ranolazine | Drug | On January 31, 2006, ranolazine was approved for use in the United States by the Food and Drug Administration (FDA) for the treatment of chronic angina pectoris. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Diarrhea Using the Bowel Symptom Score (BSS). | BSS is a 100-mm visual analog scale for each symptom of Irritable Bowel Syndrome (IBS) (pain or discomfort, bloating, and diarrhea) with an overall severity score. Lower scores indicate symptoms are not present and higher scores indicate severe symptoms. | baseline to 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Abdominal Pain | Daily abdominal pain intensity was rated using an 11-point (0-10) numeric rating scale, with 0 being no pain, and 10 being the worst pain imaginable. Participants were asked to rate their worst abdominal pain over the past 24 hours. | baseline to 4 weeks |
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Inclusion Criteria
Exclusion Criteria
Structural or metabolic diseases/conditions that affect the gastrointestinal system
Unable to withdraw the following medications 48 hours prior to the study:
Unable to withdraw the following medications, which are contraindications of ranolazine:
Female subjects who are pregnant or breastfeeding.
Current symptoms of severe depression, as measured by Hospital Anxiety And Depression Scale ( HADS) score greater than 15.
Clinical evidence (including physical exam, ECG, laboratory studies and review of the medical history) of significant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematological, neurological, psychiatric, or other disease that interfere with the objectives of the study.
The Corrected QT Interval (QTc) > 490 msec.
Active alcoholics not in remission or known substance abusers.
Liver cirrhosis
Patients with clinically significant hepatic disease.
Major cardiovascular events in the last 6 months.
Participation in another clinical trial (within 30 days).
Incarcerated.
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| Name | Affiliation | Role |
|---|---|---|
| Yuri A Saito, MD,MPH | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
2 subjects were screen failures and were not randomized.
1 subject signed informed consent, but the study was suspended prior to that subject's randomization.
Subjects were enrolled at Mayo Clinic, Rochester Minnesota.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ranolazine | tablet, 1000 mg twice daily for four weeks |
| FG001 | Placebo | Placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ranolazine | tablet, 1000 mg twice daily for four weeks |
| BG001 | Placebo | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Number |
| 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 From Baseline in Diarrhea Using the Bowel Symptom Score (BSS). | BSS is a 100-mm visual analog scale for each symptom of Irritable Bowel Syndrome (IBS) (pain or discomfort, bloating, and diarrhea) with an overall severity score. Lower scores indicate symptoms are not present and higher scores indicate severe symptoms. | The one subject who completed the study did not have complete data, so no analysis was performed. Study was terminated due to difficulty with enrollment. | Posted | baseline to 4 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 | Ranolazine | tablet, 1000 mg twice daily for four weeks |
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The study was terminated early due to enrollment issues.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Yuri Saito Loftus | Mayo Clinic | 507-255-3680 | saito.yuri@mayo.edu |
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| ID | Term |
|---|---|
| D000069458 | Ranolazine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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|
| Placebo | Drug |
|
| BG002 |
| Total |
Total of all reporting groups |
| participants |
|
| Gender | Number | participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Mean Abdominal Pain | Daily abdominal pain intensity was rated using an 11-point (0-10) numeric rating scale, with 0 being no pain, and 10 being the worst pain imaginable. Participants were asked to rate their worst abdominal pain over the past 24 hours. | The one subject who completed the study did not have complete data, so no analysis was performed. Study was terminated due to difficulty with enrollment. | Posted | baseline to 4 weeks |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Placebo | Placebo | 0 | 2 | 0 | 2 |
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| Aniline Compounds |
| D000588 | Amines |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |