Evaluate Safety and Efficacy of 25 mg Hydrocortisone Acetate Suppositories in Treatment of Internal Hemorrhoids
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Waitlist Available
Sponsor: Nivagen Pharmaceuticals Inc.
Prior Safety Data
Trial Summary
What is the purpose of this trial?A randomized, double-blind, placebo-controlled, multicenter, parallel group study of the safety and efficacy of Hydrocortisone Acetate Suppositories, 25 mg compared to placebo suppositories in the treatment of symptomatic internal hemorrhoids.
Eligibility Criteria
Inclusion Criteria
internal hemorrhoids.
hemorrhoidal bleeding.
male or female aged 18 years and older.
+2 more
Participant Groups
2Treatment groups
Active Control
Placebo Group
Group I: Hydrocortisone Acetate Suppository, 25 mgActive Control1 Intervention
One (1) Hydrocortisone Acetate Suppository, 25 mg is inserted into the anal canal twice daily (morning and evening) for 2 weeks (14 days).
Group II: Placebo (Vehicle) SuppositoryPlacebo Group1 Intervention
One (1) Placebo (Vehicle) Suppository is inserted into the anal canal twice daily (morning and evening) for 2 weeks (14 days).
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Clinical ResearchCharlotte, NC
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Who Is Running the Clinical Trial?
Nivagen Pharmaceuticals Inc.Lead Sponsor