Trial Outcomes & Findings for Evaluate Safety and Efficacy of 25 mg Hydrocortisone Acetate Suppositories in Treatment of Internal Hemorrhoids (NCT NCT03335774)

Last Updated: 2022-09-13

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

103 participants

Primary outcome timeframe

Day 15

Results posted on

2022-09-13

Participant Flow

Mostly patients were recruited from the existing database

Participant milestones

Participant milestones
Measure	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). 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 (Vehicle) Suppository One (1) Placebo (Vehicle) Suppository is inserted into the anal canal twice daily (morning and evening) for 2 weeks (14 days). Placebo (Vehicle) Suppository: One (1) Placebo (Vehicle) Suppository is inserted into the anal canal twice daily (morning and evening) for 2 weeks (14 days).
Overall Study STARTED	51	52
Overall Study COMPLETED	50	51
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

1 subject in each of treatment arms did not meet threshold compliance % of completing the PRO questionnaire, and hence could not be included in the analysis.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Hydrocortisone Acetate Suppository, 25 mg n=51 Participants 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: One (1) Hydrocortisone Acetate Suppository, 25 mg is inserted into the anal canal twice daily (morning and evening) for 2 weeks (14 days).	Placebo (Vehicle) Suppository n=52 Participants One (1) Placebo (Vehicle) Suppository is inserted into the anal canal twice daily (morning and evening) for 2 weeks (14 days). Placebo (Vehicle) Suppository: One (1) Placebo (Vehicle) Suppository is inserted into the anal canal twice daily (morning and evening) for 2 weeks (14 days).	Total n=103 Participants Total of all reporting groups
Age, Continuous	50.5 years STANDARD_DEVIATION 15.43 • n=51 Participants	50.8 years STANDARD_DEVIATION 15.57 • n=52 Participants	50.6 years STANDARD_DEVIATION 15.42 • n=103 Participants
Sex: Female, Male Female	20 Participants n=51 Participants	25 Participants n=52 Participants	45 Participants n=103 Participants
Sex: Female, Male Male	31 Participants n=51 Participants	27 Participants n=52 Participants	58 Participants n=103 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	24 Participants n=51 Participants	22 Participants n=52 Participants	46 Participants n=103 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	27 Participants n=51 Participants	30 Participants n=52 Participants	57 Participants n=103 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=51 Participants	0 Participants n=52 Participants	0 Participants n=103 Participants
Region of Enrollment United States	30 Participants n=51 Participants	30 Participants n=52 Participants	60 Participants n=103 Participants
Region of Enrollment India	21 Participants n=51 Participants	22 Participants n=52 Participants	43 Participants n=103 Participants
Swelling of hemorrhoid	2.9 scores on a scale STANDARD_DEVIATION 0.68 • n=51 Participants	2.8 scores on a scale STANDARD_DEVIATION 0.60 • n=52 Participants	2.85 scores on a scale STANDARD_DEVIATION 0.64 • n=103 Participants
Itching severity	2.15 Scores on a scale STANDARD_DEVIATION 0.49 • n=50 Participants • 1 subject in each of treatment arms did not meet threshold compliance % of completing the PRO questionnaire, and hence could not be included in the analysis.	2.12 Scores on a scale STANDARD_DEVIATION 0.50 • n=51 Participants • 1 subject in each of treatment arms did not meet threshold compliance % of completing the PRO questionnaire, and hence could not be included in the analysis.	2.13 Scores on a scale STANDARD_DEVIATION 0.5 • n=101 Participants • 1 subject in each of treatment arms did not meet threshold compliance % of completing the PRO questionnaire, and hence could not be included in the analysis.

PRIMARY outcome

Timeframe: Day 15

Outcome measures

Outcome measures
Measure	Hydrocortisone Acetate Suppository, 25 mg n=50 Participants 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: One (1) Hydrocortisone Acetate Suppository, 25 mg is inserted into the anal canal twice daily (morning and evening) for 2 weeks (14 days).	Placebo (Vehicle) Suppository n=51 Participants One (1) Placebo (Vehicle) Suppository is inserted into the anal canal twice daily (morning and evening) for 2 weeks (14 days). Placebo (Vehicle) Suppository: One (1) Placebo (Vehicle) Suppository is inserted into the anal canal twice daily (morning and evening) for 2 weeks (14 days).
Reduction in Swelling	2.3 scores on a scale Standard Deviation 0.74	2.0 scores on a scale Standard Deviation 0.68

PRIMARY outcome

Timeframe: Day 15

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

Outcome measures

Outcome measures
Measure	Hydrocortisone Acetate Suppository, 25 mg n=50 Participants 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: One (1) Hydrocortisone Acetate Suppository, 25 mg is inserted into the anal canal twice daily (morning and evening) for 2 weeks (14 days).	Placebo (Vehicle) Suppository n=51 Participants One (1) Placebo (Vehicle) Suppository is inserted into the anal canal twice daily (morning and evening) for 2 weeks (14 days). Placebo (Vehicle) Suppository: One (1) Placebo (Vehicle) Suppository is inserted into the anal canal twice daily (morning and evening) for 2 weeks (14 days).
Reduction in Itching Severity	0.74 scores on a scale Standard Deviation 0.56	0.71 scores on a scale Standard Deviation 0.61

Adverse Events

Hydrocortisone Acetate Suppository, 25 mg

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Placebo (Vehicle) Suppository

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Hydrocortisone Acetate Suppository, 25 mg n=50 participants at risk 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: One (1) Hydrocortisone Acetate Suppository, 25 mg is inserted into the anal canal twice daily (morning and evening) for 2 weeks (14 days).	Placebo (Vehicle) Suppository n=51 participants at risk One (1) Placebo (Vehicle) Suppository is inserted into the anal canal twice daily (morning and evening) for 2 weeks (14 days). Placebo (Vehicle) Suppository: One (1) Placebo (Vehicle) Suppository is inserted into the anal canal twice daily (morning and evening) for 2 weeks (14 days).
Metabolism and nutrition disorders Hyperkalemia	2.0% 1/50 • Number of events 1 • Total time period for which AE data was collected was ~6 weeks for each subject Hydrocortisone suppositories have been prescribed for 5 decades for the management of internal hemorrhoids. The formulation is expected to act locally, with negligible systemic absorption. Therefore, risk of SAEs and mortality are non-existent.	3.9% 2/51 • Number of events 2 • Total time period for which AE data was collected was ~6 weeks for each subject Hydrocortisone suppositories have been prescribed for 5 decades for the management of internal hemorrhoids. The formulation is expected to act locally, with negligible systemic absorption. Therefore, risk of SAEs and mortality are non-existent.

Additional Information

Dr Vishal S Narang

Nivagen Pharmaceuticals

Phone: +919820020278

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place