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This Study is intended to evaluate the safety and effectiveness of Ameparomo Capsules 250 mg under actual medical practice.
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Drug Reactions | An adverse drug reaction (ADR) was any untoward medical occurrence attributed to AMEPAROMO capsules in a participant who received AMEPAROMO capsules. A serious ADR was an ADR resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Relatedness to AMEPAROMO capsules was assessed by the physician. | 38 days at maximum |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Cyst Negative | Proportion of cyst negative, which was defined as the percentage of participants with negative results in the examination of cysts after AMEPAROMO capsules up to 3 months after the completion of observation period or discontinuation of treatment, was presented along with its 2-sided 95% CI. The results of the examination of cysts were assessed as "negative ", "positive", or "indeterminate". |
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Inclusion Criteria:
Exclusion Criteria:
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Sites of infection department, internal medicine, and other relevant departments.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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| ID | Title | Description |
|---|---|---|
| FG000 | AMEPAROMO Capsules (Paromomycin) | Participants who received AMEPAROMO capsules as indicated in the approved local product document were observed for a period of 10 days at maximum. The dosage can be adjusted as per physician's discretion. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
A total of 120 participants were enrolled in this study. Of the 120 participants, 5 participants were excluded from the safety analysis set due to following reasons: no visit after the first prescription day (n=5).
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| ID | Title | Description |
|---|---|---|
| BG000 | AMEPAROMO Capsules (Paromomycin) | Participants who received AMEPAROMO capsules as indicated in the approved local product document were observed for a period of 10 days at maximum. The dosage can be adjusted as per physician's discretion. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 | Number of Participants With Adverse Drug Reactions | An adverse drug reaction (ADR) was any untoward medical occurrence attributed to AMEPAROMO capsules in a participant who received AMEPAROMO capsules. A serious ADR was an ADR resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Relatedness to AMEPAROMO capsules was assessed by the physician. | The safety analysis set comprised of participants who satisfied the inclusion criteria and had received AMEPAROMO capsules at least once. | Posted | Number | Particpants | 38 days at maximum |
|
38 days at maximum
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AMEPAROMO Capsules (Paromomycin) | Participants who received AMEPAROMO capsules as indicated in the approved local product document were observed for a period of 10 days at maximum. The dosage can be adjusted as per physician's discretion. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 21.1 | Non-systematic Assessment | Diarrhoea |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 2, 2016 | Dec 11, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 10, 2018 | Dec 11, 2019 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D004404 | Dysentery, Amebic |
| ID | Term |
|---|---|
| D007411 | Intestinal Diseases, Parasitic |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
| D000562 | Amebiasis |
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| 10 days + 3 months at maximum |
| Overall Clinical Response Rate | Clinical response rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of assessable effectiveness analysis population, was presented along with its 2-sided 95% CI. Clinical response of AMEPAROMO capsules was assessed as "effective", "not effective", or "indeterminate" by the physician based on the clinical course at the end of the observation period or at the time of treatment discontinuation. | 10 days at maximum |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
|
|
| Secondary | Proportion of Cyst Negative | Proportion of cyst negative, which was defined as the percentage of participants with negative results in the examination of cysts after AMEPAROMO capsules up to 3 months after the completion of observation period or discontinuation of treatment, was presented along with its 2-sided 95% CI. The results of the examination of cysts were assessed as "negative ", "positive", or "indeterminate". | The cyst analysis set consists of the participants in the safety analysis set who have undergone the cyst examination at the end of the observation period or at the time of treatment discontinuation. Participants with no information on cyst examination (53) and those with non-target disease (9) were excluded. | Posted | Number | 95% Confidence Interval | Percentage of Participants | 10 days + 3 months at maximum |
|
|
|
| Secondary | Overall Clinical Response Rate | Clinical response rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of assessable effectiveness analysis population, was presented along with its 2-sided 95% CI. Clinical response of AMEPAROMO capsules was assessed as "effective", "not effective", or "indeterminate" by the physician based on the clinical course at the end of the observation period or at the time of treatment discontinuation. | The clinical response analysis set comprised of participants in the safety analysis set who had effectiveness evaluation at the end of the observation period or at the time of treatment discontinuation. Participants with non-target disease (9) and participants who assessed as indeterminate at the final observation (6) were excluded. | Posted | Number | 95% Confidence Interval | Percentage of Participants | 10 days at maximum |
|
|
|
| 0 |
| 115 |
| 0 |
| 115 |
| 18 |
| 115 |
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Non-systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 21.1 | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 21.1 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| D011528 |
| Protozoan Infections |
| D004403 | Dysentery |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |