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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03335774
Recruitment Status : Completed
First Posted : November 8, 2017
Last Update Posted : April 14, 2021
Sponsor:
Information provided by (Responsible Party):
Nivagen Pharmaceuticals Inc.

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
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 : February 12, 2019
Actual Primary Completion Date : March 5, 2021
Actual Study Completion Date : March 5, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hemorrhoids

Arms and Interventions
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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
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Primary Outcome Measures :
  1. Change in swelling [ Time Frame: Days 1, 15 ]
    Anoscopy

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

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

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

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

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

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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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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


Locations
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United States, North Carolina
Clinical Research
Charlotte, North Carolina, United States, 28217
India
Clinical Research
Navi Mumbai, Maharashtra, India, 400701
Sponsors and Collaborators
Nivagen Pharmaceuticals Inc.
More Information
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Additional Information:

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Responsible Party: Nivagen Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT03335774    
Other Study ID Numbers: HDCS 1701 (formerly 1-2017)
First Posted: November 8, 2017    Key Record Dates
Last Update Posted: April 14, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hemorrhoids
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Vascular Diseases
 Cardiovascular Diseases
Hydrocortisone
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Hydrocortisone hemisuccinate
Anti-Inflammatory Agents