Efficacy Study of Iferanserin to Treat Hemorrhoids
Protocol for the Study of the Effects of S-MPEC (Iferanserin) in Patients With Hemorrhoids
1 other identifier
interventional
121
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2001
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2001
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2002
CompletedFirst Submitted
Initial submission to the registry
November 22, 2011
CompletedFirst Posted
Study publicly available on registry
December 1, 2011
CompletedAugust 21, 2013
November 1, 2011
11 months
November 22, 2011
August 19, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
Assessment of bleeding, hemorrhoid size, other hemorrhoid symptoms, and physician evaluation of hemorrhoids.
14 days
Study Arms (2)
Iferanserin
ACTIVE COMPARATORIferanserin administration intra-anally twice daily for 14 days
Placebo
PLACEBO COMPARATORPlacebo administration intra-anally twice daily for 14 days
Interventions
Iferanserin 0.5% ointment applied intra-anally twice daily for 14 days
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Prof. Alexander Herold, MD
Mannheim, Germany
Related Publications (1)
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.
PMID: 22244049DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 22, 2011
First Posted
December 1, 2011
Study Start
September 1, 2001
Primary Completion
August 1, 2002
Study Completion
August 1, 2002
Last Updated
August 21, 2013
Record last verified: 2011-11