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

This study is not yet open for participant recruitment.
Verified November 2017 by Nivagen Pharmaceuticals Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT03335774
First Posted: November 8, 2017
Last Update Posted: November 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Nivagen Pharmaceuticals Inc.
  Purpose
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 Intervention Phase
Internal Hemorrhoids Drug: Hydrocortisone Acetate Suppository, 25 mg Drug: Placebo (Vehicle) Suppository Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Nivagen Pharmaceuticals Inc.:

Primary Outcome Measures:
  • Change in swelling [ Time Frame: Days 1, 15 ]
    Anoscopy

  • Change in bleeding [ Time Frame: Days 1-29 ]
    Questionnaire

  • Change in itching [ Time Frame: Days 1-29 ]
    Questionnaire

  • Change in swelling [ Time Frame: Days 1-29 ]
    Questionnaire

  • Change in pain [ Time Frame: Days 1-29 ]
    Questionnaire

  • Change in discomfort [ Time Frame: Days 1-29 ]
    Questionnaire

  • Change in overall severity [ Time Frame: Days 1-29 ]
    Questionnaire


Estimated Enrollment: 100
Anticipated Study Start Date: November 2017
Estimated Study Completion Date: October 2018
Estimated Primary Completion Date: October 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03335774


Contacts
Contact: Anand Shukla, MS, MBA, Vice President, Research & Development 1-888-412-3110 clinicaltrials@nivagen.com

Sponsors and Collaborators
Nivagen Pharmaceuticals Inc.
  More Information

Additional Information:
Responsible Party: Nivagen Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT03335774     History of Changes
Other Study ID Numbers: 1-2017
First Submitted: October 30, 2017
First Posted: November 8, 2017
Last Update Posted: November 8, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
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
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Vascular Diseases
Cardiovascular Diseases
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Cortisol succinate
Hydrocortisone
Anti-Inflammatory Agents