NCT03335774

Evaluate Safety and Efficacy of 25 mg Hydrocortisone Acetate Suppositories in Treatment of Internal Hemorrhoids

A Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel Group Study to Evaluate Safety and Efficacy of 25 mg Hydrocortisone Acetate Suppositories in the Treatment of Symptomatic Internal Hemorrhoids.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 103 (actual)
• Sponsor: Nivagen Pharmaceuticals Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

STUDY DESIGN: 25 mg hydrocortisone suppositories administered twice daily compared to a vehicle placebo in approximately 100 subjects with symptomatic internal hemorrhoids. Subjects will be randomized in a 1:1 ratio (Test product: placebo). The study will consist of 2 periods: 1. Treatment Period (2 weeks/ Days 1-14) 2. Follow-up Period (2 weeks/ Days 15-28) The visits are as follows: Visit 1 (Day 1 Baseline/Randomization) Visit 2 (Day 8±1, Interim Visit) Visit 3 (Day 15±2, End of Treatment Visit) Visit 4 (Day 29±3, End of Study Visit) ENDPOINTS: 1. Clinician Reported Outcome (ClinRO) - Anoscopy (Visits 1, 3). Anoscopy - Visual assessment of hemorrhoids. Video of the procedure will be recorded for blinded central reading and assessment 2. Patient Reported Outcome: Subjects will use Daily Diaries to record the time and date of each medication application, concomitant medication and adverse events. The subjects will complete the Subject Questionnaire at Visits 1, 2, 3 and 4 (or early termination) and daily between visits.

Conditions

• Internal Hemorrhoids

Interventions

Type	Name	Description
DRUG	Hydrocortisone Acetate Suppository, 25 mg (Nivagen)	One (1) Hydrocortisone Acetate Suppository, 25 mg is inserted into the anal canal twice daily (morning and evening) for 2 weeks (14 days).
DRUG	Placebo (Vehicle) Suppository (Nivagen)	One (1) Placebo (Vehicle) Suppository is inserted into the anal canal twice daily (morning and evening) for 2 weeks (14 days).

Timeline

• Start date: 2019-02-12
• Primary completion: 2021-03-05
• Completion: 2021-03-05
• First posted: 2017-11-08
• Last updated: 2022-09-13
• Results posted: 2022-09-13

Locations

2 sites across 2 countries: United States, India

Regulatory

• FDA-regulated drug study