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To evaluate the safety and efficacy of topical 0.5% S-MPEC cream vs. placebo cream (applied twice daily for 14 days) in the treatment of Grade I - III hemorrhoids.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Iferanserin | Active Comparator | Iferanserin administration intra-anally twice daily for 14 days |
|
| Placebo | Placebo Comparator | Placebo administration intra-anally twice daily for 14 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Iferanserin | Drug | Iferanserin 0.5% ointment applied intra-anally twice daily for 14 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of hemorrhoid bleeding | Change from pre-treatment in patient assessment of hemorrhoid bleeding (10-point scale: 1=Not at all, 10=Extremely) at the end of one- and two-weeks of treatment are the primary efficacy endpoints for the study. | Day 7 and 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of bleeding, hemorrhoid size, other hemorrhoid symptoms, and physician evaluation of hemorrhoids. | Change from pre-treatment in patient assessment of bleeding on other treatment days, change from pre-treatment in hemorrhoid size, change from pre-treatment in patient assessment of other hemorrhoid symptoms/conditions on all treatment days, and physician evaluation of hemorrhoids at the end of treatment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prof. Alexander Herold, MD | Mannheim | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22244049 | Derived | Herold A, Dietrich J, Aitchison R. Intra-anal Iferanserin 10 mg BID for hemorrhoid disease: a prospective, randomized, double-blind, placebo-controlled trial. Clin Ther. 2012 Feb;34(2):329-40. doi: 10.1016/j.clinthera.2011.12.012. Epub 2012 Jan 11. |
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| ID | Term |
|---|---|
| D006484 | Hemorrhoids |
| ID | Term |
|---|---|
| D012002 | Rectal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C572904 | iferanserin |
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| Placebo | Drug | Placebo ointment applied intra-anally twice daily for 14 days |
|
| 14 days |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |