Trial · NCT03335774
Evaluate Safety and Efficacy of 25 mg Hydrocortisone Acetate Suppositories in Treatment of Internal Hemorrhoids
NCT03335774, Phase 2, Completed, Nivagen Pharmaceuticals Inc.; results first posted 2022-09-13
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Evaluate Safety and Efficacy of 25 mg Hydrocortisone Acetate Suppositories in Treatment of Internal Hemorrhoids. Trials, record NCT03335774. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03335774
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluate Safety and Efficacy of 25 mg Hydrocortisone Acetate Suppositories in Treatment of Internal Hemorrhoids
- NCT number
- NCT03335774
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 103 participants, actual
- Lead sponsor
- Nivagen Pharmaceuticals Inc.
- Conditions
- Internal Hemorrhoids
- Interventions
- Hydrocortisone Acetate Suppository, 25 mg (Nivagen), Placebo (Vehicle) Suppository (Nivagen)
- First posted
- 2017-11-08
- Last updated
- 2022-09-13
- Results first posted
- 2022-09-13
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Reduction in Swelling | Day 15 | 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. |
| Primary | Reduction in Itching Severity | 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 |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Reduction in Swelling | Day 15 | scores on a scale | MEAN | |
| PRIMARY | Reduction in Itching Severity | Day 15 | scores on a scale | MEAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Reduction in Swelling | Hydrocortisone Acetate Suppository, 25 mg | 2.3 | Standard Deviation 0.74 | scores on a scale | |
| Reduction in Swelling | Placebo (Vehicle) Suppository | 2.0 | Standard Deviation 0.68 | scores on a scale | |
| Reduction in Itching Severity | Hydrocortisone Acetate Suppository, 25 mg | 0.74 | Standard Deviation 0.56 | scores on a scale | |
| Reduction in Itching Severity | Placebo (Vehicle) Suppository | 0.71 | Standard Deviation 0.61 | scores on a scale |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Hydrocortisone Acetate Suppository, 25 mg | 51 | |
| Overall Study | STARTED | Placebo (Vehicle) Suppository | 52 | |
| Overall Study | COMPLETED | Hydrocortisone Acetate Suppository, 25 mg | 50 | |
| Overall Study | COMPLETED | Placebo (Vehicle) Suppository | 51 | |
| Overall Study | NOT COMPLETED | Hydrocortisone Acetate Suppository, 25 mg | 1 | |
| Overall Study | NOT COMPLETED | Placebo (Vehicle) Suppository | 1 |
Source ClinicalTrials.gov
Adverse events2
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Hyperkalemia | Metabolism and nutrition disorders | Hydrocortisone Acetate Suppository, 25 mg | 1 | 50 | 1 |
| other | Hyperkalemia | Metabolism and nutrition disorders | Placebo (Vehicle) Suppository | 2 | 51 | 2 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Hydrocortisone Acetate Suppository, 25 mg | 0 | 50 |
| Total, all-cause mortality | Placebo (Vehicle) Suppository | 0 | 51 |
| Total, other adverse events | Hydrocortisone Acetate Suppository, 25 mg | 1 | 50 |
| Total, other adverse events | Placebo (Vehicle) Suppository | 2 | 51 |
| Total, serious adverse events | Hydrocortisone Acetate Suppository, 25 mg | 0 | 50 |
| Total, serious adverse events | Placebo (Vehicle) Suppository | 0 | 51 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Hydrocortisone Acetate Suppository, 25 mg vs Placebo (Vehicle) Suppository: deaths from any cause | Trial comparisons |
| Hydrocortisone Acetate Suppository, 25 mg vs Placebo (Vehicle) Suppository: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03335774
GET https://conductscience.org/api/trials/v1/NCT03335774/registered