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Efficacy Study of Iferanserin to Treat Hemorrhoids

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ventrus Biosciences, Inc
ClinicalTrials.gov Identifier:
NCT01483833
First received: November 22, 2011
Last updated: August 19, 2013
Last verified: November 2011

November 22, 2011
August 19, 2013
September 2001
August 2002   (final data collection date for primary outcome measure)
Assessment of hemorrhoid bleeding [ Time Frame: Day 7 and 14 ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01483833 on ClinicalTrials.gov Archive Site
Assessment of bleeding, hemorrhoid size, other hemorrhoid symptoms, and physician evaluation of hemorrhoids. [ Time Frame: 14 days ] [ Designated as safety issue: No ]
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.
Same as current
Not Provided
Not Provided
 
Efficacy Study of Iferanserin to Treat Hemorrhoids
Protocol for the Study of the Effects of S-MPEC (Iferanserin) in Patients With 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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Hemorrhoids
  • Drug: Iferanserin
    Iferanserin 0.5% ointment applied intra-anally twice daily for 14 days
    Other Name: VEN309
  • Drug: Placebo
    Placebo ointment applied intra-anally twice daily for 14 days
  • Active Comparator: Iferanserin
    Iferanserin administration intra-anally twice daily for 14 days
    Intervention: Drug: Iferanserin
  • Placebo Comparator: Placebo
    Placebo administration intra-anally twice daily for 14 days
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
121
August 2002
August 2002   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01483833
VEN309-SMPEC-001
No
Ventrus Biosciences, Inc
Ventrus Biosciences, Inc
Not Provided
Not Provided
Ventrus Biosciences, Inc
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP