Clinical trial NCT03335774: Evaluate Safety and Efficacy of 25 mg Hydrocortisone Acetate Suppositories in Treatment of Internal Hemorrhoids
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Internal Hemorrhoids
Lead sponsor: Nivagen Pharmaceuticals Inc.
Sponsor class: INDUSTRY
First posted: 2017-11-08
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Reduction in Swelling
timeFrame: Day 15
measure: Reduction in Itching Severity
timeFrame: Day 15
Secondary outcomes:
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Clinical Research
state: North Carolina
city: Navi Mumbai
country: India
facility: Clinical Research
state: Maharashtra
Study officials:
affiliation: Nivagen Pharmaceuticals
name: Anand Shukla, MS, MBA,
role: STUDY_DIRECTOR
References: