Trial | NCT01483833  Report issue

Title

Efficacy Study of Iferanserin to Treat Hemorrhoids
Protocol for the Study of the Effects of S-MPEC (Iferanserin) in Patients With Hemorrhoids

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    iferanserin ...

  • Study Participants

    121
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.
Study Started
Sep 30
2001
Primary Completion
Aug 31
2002
Study Completion
Aug 31
2002
Last Update
Aug 21
2013
Estimate

Drug Iferanserin

Iferanserin 0.5% ointment applied intra-anally twice daily for 14 days

  • Other names: VEN309

Drug Placebo

Placebo ointment applied intra-anally twice daily for 14 days

Iferanserin Active Comparator

Iferanserin administration intra-anally twice daily for 14 days

Placebo Placebo Comparator

Placebo administration intra-anally twice daily for 14 days

Criteria 

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.
No Results Posted