Study of the Safety and Efficacy of Hydrocortisone Acetate Suppositories, 25 mg in the Treatment of Symptomatic Internal Hemorrhoids

• Sponsor: Nivagen Pharmaceuticals Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03335774
• Collaborator: (none)
• Enrollment: 103
• Locations: 2
• Arms: 2
• Actual Duration (Months): 24.7
• Patients Per Site: 51.5
• Patients Per Site Per Month: 2.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Internal Hemorrhoids	Drug: Hydrocortisone Acetate Suppository, 25 mg; Drug: Placebo (Vehicle) Suppository	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 103 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: Feb 12, 2019
• Actual Primary Completion Date: Mar 5, 2021
• Actual Study Completion Date: Mar 5, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Hydrocortisone Acetate Suppository, 25 mg One (1) Hydrocortisone Acetate Suppository, 25 mg is inserted into the anal canal twice daily (morning and evening) for 2 weeks (14 days).	Drug: Hydrocortisone Acetate Suppository, 25 mg; One (1) Hydrocortisone Acetate Suppository, 25 mg is inserted into the anal canal twice daily (morning and evening) for 2 weeks (14 days).
Placebo Comparator: Placebo (Vehicle) Suppository One (1) Placebo (Vehicle) Suppository is inserted into the anal canal twice daily (morning and evening) for 2 weeks (14 days).	Drug: Placebo (Vehicle) Suppository; One (1) Placebo (Vehicle) Suppository is inserted into the anal canal twice daily (morning and evening) for 2 weeks (14 days).

Outcome Measures

Primary Outcome Measures

1. Change in swelling [Days 1, 15]

   Anoscopy

2. Change in bleeding [Days 1-29]

   Questionnaire

3. Change in itching [Days 1-29]

   Questionnaire

4. Change in swelling [Days 1-29]

   Questionnaire

5. Change in pain [Days 1-29]

   Questionnaire

6. Change in discomfort [Days 1-29]

   Questionnaire

7. Change in overall severity [Days 1-29]

   Questionnaire

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinical Research	Charlotte	North Carolina	United States	28217
2	Clinical Research	Navi Mumbai	Maharashtra	India	400701

Sponsors and Collaborators

• Nivagen Pharmaceuticals Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Nivagen Pharmaceuticals Inc.

Publications

None provided.

• Responsible Party: Nivagen Pharmaceuticals Inc.
• ClinicalTrials.gov Identifier: NCT03335774
• Other Study ID Numbers: HDCS 1701 (formerly 1-2017)
• First Posted: Nov 8, 2017
• Last Update Posted: Apr 14, 2021
• Last Verified: Apr 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hemorrhoids; Hydrocortisone; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate; Hydrocortisone hemisuccinate

Study Results

No Results Posted as of Apr 14, 2021