NCT03335774

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
103

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Feb 2019

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 30, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 8, 2017

Completed
1.3 years until next milestone

Study Start

First participant enrolled

February 12, 2019

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 5, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 5, 2021

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

September 13, 2022

Completed
Last Updated

September 13, 2022

Status Verified

August 1, 2022

Enrollment Period

2.1 years

First QC Date

October 30, 2017

Results QC Date

April 27, 2022

Last Update Submit

August 18, 2022

Conditions

Internal Hemorrhoids

Outcome Measures

Primary Outcomes (2)

  • Reduction in Swelling

    Reduction in the swelling of internal hemorrhoid was measured by anoscopy. Visual assessment of hemorrhoids was performed at end of treatment. Video of the procedure will be recorded for blinded central reading and assessment. Swelling was graded on a scale from "0 - None" to "4 - Very Severe". Numeric grades and their changes from baseline are summarized descriptively by visit and treatment group. Changes from baseline will be compared between the treatment groups. Mean difference between the groups and its 95% confidence interval will be displayed at Visit 4, along with the p-value from the two-sample t-test.

    Day 15

  • Reduction in Itching Severity

    Patient-reported outcome (PRO) was collated and analyzed by deploying the Internal Hemorrhoid Sign and Symptom Assessment (IHSSA) questionnaire. The patients updated the questionnaire on a daily basis between visits 1-5. Responses to each item were averaged across each period. The mean score from the Screening period was considered the baseline score. Mean scores and their changes from baseline were summarized. Itching was scored from on 0-4 scale (0 =No itching, 1 = A little itching, 2 =Moderate itching, 3 = A lot of itching, 4 = Worst itching that you could imagine

    Day 15

Study Arms (2)

Hydrocortisone Acetate Suppository, 25 mg

ACTIVE COMPARATOR

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 (Nivagen)

Placebo (Vehicle) Suppository

PLACEBO COMPARATOR

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 (Nivagen)

Interventions

Hydrocortisone Acetate Suppository, 25 mg (Nivagen)DRUG

One (1) Hydrocortisone Acetate Suppository, 25 mg is inserted into the anal canal twice daily (morning and evening) for 2 weeks (14 days).

Hydrocortisone Acetate Suppository, 25 mg
Placebo (Vehicle) Suppository (Nivagen)DRUG

One (1) Placebo (Vehicle) Suppository is inserted into the anal canal twice daily (morning and evening) for 2 weeks (14 days).

Placebo (Vehicle) Suppository

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Clinical Research

Charlotte, North Carolina, 28217, United States

Location

Clinical Research

Navi Mumbai, Maharashtra, 400701, India

Location

Related Links

MeSH Terms

Interventions

Suppositories

Intervention Hierarchy (Ancestors)

Dosage FormsPharmaceutical Preparations

Results Point of Contact

Title
Dr Vishal S Narang
Organization
Nivagen Pharmaceuticals
vnarang@nivagen.com
+919820020278

Study Officials

  • Anand Shukla, MS, MBA,

    Nivagen Pharmaceuticals

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 30, 2017

First Posted

November 8, 2017

Study Start

February 12, 2019

Primary Completion

March 5, 2021

Study Completion

March 5, 2021

Last Updated

September 13, 2022

Results First Posted

September 13, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

IN(1)US(1)