Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Anand Shukla, MS, MBA, | Nivagen Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research | Charlotte | North Carolina | 28217 | United States | ||
| Clinical Research |
Not provided
| Label | URL |
|---|---|
| Nivagen Pharmaceuticals Inc. | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Mostly patients were recruited from the existing database
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 26, 2019 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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). |
|
| Navi Mumbai |
| Maharashtra |
| 400701 |
| India |
| FG001 |
| 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). |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| BG001 | 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). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
| ||||||||||||||||
| Swelling of hemorrhoid | At Baseline, objective measurement of swelling of hemorrhoids was conducted utilizing Anoscopy. Recorded Video was sent for blinded central reading and assessment, and rated as: No swelling, score of 0; Mild swelling : score of 1; Moderate swelling: score of 2; Severe swelling: score of 3; Very Severe swelling: score of 4 | Mean | Standard Deviation | scores on a scale |
| ||||||||||||||
| Itching severity | During the baseline period, patient-reported outcome (PRO) associated with symptom of 'itching' was collated by deploying the Internal Hemorrhoid Sign and Symptom Assessment (IHSSA) questionnaire. The mean score from the Screening period was considered the baseline score. 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) | 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. | Mean | Standard Deviation | Scores on a scale |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | scores on a scale | Day 15 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | 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 | Posted | Mean | Standard Deviation | scores on a scale | Day 15 |
|
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). | 0 | 50 | 0 | 50 | 1 | 50 |
| EG001 | 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). | 0 | 51 | 0 | 51 | 2 | 51 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hyperkalemia | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment | Excess calclium |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Vishal S Narang | Nivagen Pharmaceuticals | +919820020278 | vnarang@nivagen.com |
| May 20, 2022 |
| Prot_SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D013488 | Suppositories |
| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
Not provided
Not provided
|
|
|
| India |
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|