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

Nivagen Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Internal Hemorrhoids

Treatments: Drug: Hydrocortisone Acetate Suppository, 25 mg (Nivagen); Drug: Placebo (Vehicle) Suppository (Nivagen)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03335774

HDCS 1701 (formerly 1-2017)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 103 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• internal hemorrhoids.
• hemorrhoidal bleeding.
• male or female aged 18 years and older.
• willing to forego the use of non-prescription (OTC) and prescription medication or procedures for the treatment of hemorrhoidal disease and/or pain for the duration of the study.
• agree to not change their diet during the study.

Exclusion criteria

• external hemorrhoids.
• using other OTC or prescription medications for treatment of hemorrhoidal disease and/or pain.
• pregnant or nursing female.
• received systemic glucocorticoids within the last 2 months prior to starting study.
• participated in an investigational drug study within 30 days prior to baseline.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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103 participants in 2 patient groups, including a placebo group

Hydrocortisone Acetate Suppository, 25 mg

Active Comparator group

Description:

One (1) Hydrocortisone Acetate Suppository, 25 mg is inserted into the anal canal twice daily (morning and evening) for 2 weeks (14 days).

Treatment:

Drug: Hydrocortisone Acetate Suppository, 25 mg (Nivagen)

Placebo (Vehicle) Suppository

Placebo Comparator group

Description:

One (1) Placebo (Vehicle) Suppository is inserted into the anal canal twice daily (morning and evening) for 2 weeks (14 days).

Treatment:

Drug: Placebo (Vehicle) Suppository (Nivagen)