Hemorrhoids
Conditions
Brief summary
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.
Interventions
DRUGIferanserin
Iferanserin 0.5% ointment applied intra-anally twice daily for 14 days
DRUGPlacebo
Placebo ointment applied intra-anally twice daily for 14 days
Sponsors
Ventrus Biosciences, Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 years or older * Diagnosis of grade I - III hemorrhoids with bleeding episodes of at least every other day during the last two weeks before enrollment in the study. * Patients signing the Informed Consent form.
Exclusion criteria
* Patients with protruding or irreducible hemorrhoids (grade IV). * Patients with anal fistulas, periproctitis or hemorrhagic diathesis * Patients with current history of Type I or Type II diabetes mellitus. * Patients with severe hepatic, renal or cardiovascular disorders. * Patients with any type of infectious disease. * Patients who have been involved with another experimental drug trial within the past 30 days. * Patients presently diagnosed with cancer. * Patients who have known alcohol and drug abuse. * Patients who require the use of suppositories. * Patients with blood or urine laboratory values outside the normal limits or those with values considered abnormal in the opinion of the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of hemorrhoid bleeding | Day 7 and 14 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of bleeding, hemorrhoid size, other hemorrhoid symptoms, and physician evaluation of hemorrhoids. | 14 days | 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. |
Countries
Germany
Outcome results
None listed