A Phase 2 interventional study of Hydrocortisone Acetate Suppository, 25 mg (Nivagen) and Placebo (Vehicle) Suppository (Nivagen) in Internal Hemorrhoids, sponsored by Nivagen Pharmaceuticals Inc.. Completed at 2 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-09-13.
Sponsored by Nivagen Pharmaceuticals Inc. · Phase 2, Interventional, and Treatment
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.
STUDY DESIGN:
25 mg hydrocortisone suppositories administered twice daily compared to a vehicle placebo in approximately 100 subjects with symptomatic internal hemorrhoids. Subjects will be randomized in a 1:1 ratio (Test product: placebo).
The study will consist of 2 periods:
The visits are as follows:
Visit 1 (Day 1 Baseline/Randomization) Visit 2 (Day 8±1, Interim Visit) Visit 3 (Day 15±2, End of Treatment Visit) Visit 4 (Day 29±3, End of Study Visit)
ENDPOINTS:
238 studies on the registry are indexed under Hemorrhoids; 73 are open to participants now.
This study's enrollment of 103 is close to the median of 100 across 183 interventional studies indexed under Hemorrhoids.
Browse Hemorrhoids studies →This is the only study on the registry with Nivagen Pharmaceuticals Inc. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
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)
One (1) Hydrocortisone Acetate Suppository, 25 mg is inserted into the anal canal twice daily (morning and evening) for 2 weeks (14 days).
One (1) Placebo (Vehicle) Suppository is inserted into the anal canal twice daily (morning and evening) for 2 weeks (14 days).
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.
Time frame: 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
Time frame: Day 15
Mostly patients were recruited from the existing database
| Milestone | Hydrocortisone Acetate Suppository, 25 mg | Placebo (Vehicle) Suppository |
|---|---|---|
| Started | 51 | 52 |
| Completed | 50 | 51 |
| Not completed | 1 | 1 |
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.
| scores on a scale | Hydrocortisone Acetate Suppository, 25 mg | Placebo (Vehicle) Suppository |
|---|---|---|
| Reduction in Swelling | 2.3 ± 0.74 | 2.0 ± 0.68 |
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
| scores on a scale | Hydrocortisone Acetate Suppository, 25 mg | Placebo (Vehicle) Suppository |
|---|---|---|
| Reduction in Itching Severity | 0.74 ± 0.56 | 0.71 ± 0.61 |
Collected over Total time period for which AE data was collected was ~6 weeks for each subject. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Hydrocortisone Acetate Suppository, 25 mg | 0/50 (0%) | 0/50 (0%) | 1/50 (2%) |
| Placebo (Vehicle) Suppository | 0/51 (0%) | 0/51 (0%) | 2/51 (3.9%) |
| Event | Hydrocortisone Acetate Suppository, 25 mg | Placebo (Vehicle) Suppository |
|---|---|---|
| HyperkalemiaMetabolism and nutrition disorders | 1/50 | 2/51 |
| Age, Continuous(years) | Hydrocortisone Acetate Suppository, 25 mg | Placebo (Vehicle) Suppository | Total |
|---|---|---|---|
| Mean | 50.5 ± 15.43 | 50.8 ± 15.57 | 50.6 ± 15.42 |
| Sex: Female, Male(Participants) | Hydrocortisone Acetate Suppository, 25 mg | Placebo (Vehicle) Suppository | Total |
|---|---|---|---|
| Female | 20 | 25 | 45 |
| Male | 31 | 27 | 58 |
| Ethnicity (NIH/OMB)(Participants) | Hydrocortisone Acetate Suppository, 25 mg | Placebo (Vehicle) Suppository | Total |
|---|---|---|---|
| Hispanic or Latino | 24 | 22 | 46 |
| Not Hispanic or Latino | 27 | 30 | 57 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Hydrocortisone Acetate Suppository, 25 mg | Placebo (Vehicle) Suppository | Total |
|---|---|---|---|
| United States | 30 | 30 | 60 |
| India | 21 | 22 | 43 |
| Swelling of hemorrhoid(scores on a scale) | Hydrocortisone Acetate Suppository, 25 mg | Placebo (Vehicle) Suppository | Total |
|---|---|---|---|
| Mean | 2.9 ± 0.68 | 2.8 ± 0.60 | 2.85 ± 0.64 |
| Itching severity(Scores on a scale) | Hydrocortisone Acetate Suppository, 25 mg | Placebo (Vehicle) Suppository | Total |
|---|---|---|---|
| Mean | 2.15 ± 0.49 | 2.12 ± 0.50 | 2.13 ± 0.5 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Feb 2019 to primary completion in Mar 2021, 24 months.
Results were first posted in Sep 2022, 1 year 6 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.