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Completed

NCT Number: NCT01483833

Efficacy Study of Iferanserin to Treat Hemorrhoids

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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Key information

Conditions

Hemorrhoids Cardiovascular Diseases Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Rectal Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Prof. Alexander Herold, MD

Mannheim, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Iferanserin

Drug

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

Other names: VEN309

Placebo

Drug

Placebo ointment applied intra-anally twice daily for 14 days

Primary outcomes

  1. Assessment of hemorrhoid bleeding

    Time frame: 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 outcomes

  1. Assessment of bleeding, hemorrhoid size, other hemorrhoid symptoms, and physician evaluation of hemorrhoids.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Ventrus Biosciences, Inc

Industry

Registry information

Official study title

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

Important dates

Study start
2001
Primary completion
2002
Study completion
2002
First posted
Dec 1, 2011
Registry last updated
Aug 21, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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