Phase 2
N=103
Evaluate Safety and Efficacy of 25 mg Hydrocortisone Acetate Suppositories in Treatment of Internal Hemorrhoids
Internal Hemorrhoids
Bottom Line
View on ClinicalTrials.gov: NCT03335774 ↗Enrolled (actual)
103
Serious AEs
0.0%
Results posted
Sep 2022
Primary outcome: Primary: Reduction in Swelling — 2.3; 2.0 scores on a scale — p=0.8918
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Hydrocortisone Acetate Suppository, 25 mg (Nivagen) (Drug); Placebo (Vehicle) Suppository (Nivagen) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Nivagen Pharmaceuticals Inc.
- Primary completion
- Mar 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Reduction in Swelling |
2.3; 2.0 | 0.8918 |
| PRIMARY Reduction in Itching Severity |
0.74; 0.71 | 0.8323 |
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.
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.
Data sourced from ClinicalTrials.gov (NCT03335774). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.