Trial Outcomes & Findings for Ameparomo Capsules 250 mg Drug Use Investigation (NCT NCT02680665)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

120 participants

Primary outcome timeframe

38 days at maximum

Results posted on

2020-12-09

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	120
Overall Study COMPLETED	115
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study No visit after the first prescription	5

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	AMEPAROMO Capsules (Paromomycin) n=115 Participants 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.
Age, Customized <15 years	0 Participants n=115 Participants
Age, Customized ≥15 to <65 years	100 Participants n=115 Participants
Age, Customized ≥ 65 years	15 Participants n=115 Participants
Sex: Female, Male Female	11 Participants n=115 Participants
Sex: Female, Male Male	104 Participants n=115 Participants

PRIMARY outcome

Timeframe: 38 days at maximum

Population: The safety analysis set comprised of participants who satisfied the inclusion criteria and had received AMEPAROMO capsules at least once.

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.

Outcome measures

Outcome measures
Measure	AMEPAROMO Capsules (Paromomycin) n=115 Participants 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.
Number of Participants With Adverse Drug Reactions ADRs	15 Particpants
Number of Participants With Adverse Drug Reactions Serious ADRs	0 Particpants

SECONDARY outcome

Timeframe: 10 days + 3 months at maximum

Population: 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.

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".

Outcome measures

Outcome measures
Measure	AMEPAROMO Capsules (Paromomycin) n=53 Participants 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.
Proportion of Cyst Negative	98.1 Percentage of Participants Interval 89.9 to 100.0

SECONDARY outcome

Timeframe: 10 days at maximum

Population: 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.

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.

Outcome measures

Outcome measures
Measure	AMEPAROMO Capsules (Paromomycin) n=100 Participants 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.
Overall Clinical Response Rate	99.0 Percentage of Participants Interval 94.6 to 100.0

Adverse Events

AMEPAROMO Capsules (Paromomycin)

Serious events: 0 serious events

Other events: 18 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	AMEPAROMO Capsules (Paromomycin) n=115 participants at risk 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.
Gastrointestinal disorders Diarrhoea	13.0% 15/115 • 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.
Respiratory, thoracic and mediastinal disorders Upper respiratory tract inflammation	0.87% 1/115 • 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.
Investigations Aspartate aminotransferase increased	0.87% 1/115 • 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.
Investigations Alanine aminotransferase increased	0.87% 1/115 • 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.

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER