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| ID | Type | Description | Link |
|---|---|---|---|
| Oral absorption | |||
| of Nepadutant in Infants |
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The purpose of the study is to evaluate the gastrointestinal absorption of nepadutant after single dose as oral solution (and the effect of age on its oral absorption) in infants. Oral absorption is evaluated through the drug recovery in urine.
This trial aims to evaluate the oral adsorption of nepadutant (0.1 or 0.5 mg/Kg given as one single dose as oral solution) in infants divided in three age strata (from 6 to 24 weeks old). Oral absorption is evaluated by measuring the amount of nepadutant in the urine output collected during the 24 hours after oral administration with special diapers.
Safety and tolerability of the drug will be evaluated by monitoring any changes in signs/symptoms at medical examination and vital signs during the fist 4 hours post-dose in the Hospital site and then by the parents at home up to 24 hours and 1 week post nepadutant administration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Nepadutant 0.1 mg/kg |
|
| 2 | Experimental | Nepadutant 0.5 mg/kg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nepadutant | Drug | 0.1 mg/Kg as one single oral dose divided in three age strata (from 6 to 24 weeks old) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Drug Concentration Measurement in the Urine Collected by Diapers Along 24 Hours Post Dose and One Week After Dose in All Treated Infants and by Age and Dose Subgroups. | Nepadutant was measured in the 24-h urine collection post both doses (0.1 and 0.5 mg/kg dose), in the age strata 6-<12 and 12-<18 weeks, using urinary collection/extraction from pre-weighed special fiber based diapers. | 24 hours |
| Drug Concentration Measurement in the Urine Collected by Diapers Along 24 Hours Post Dose and One Week After Dose in All Treated Infants and by Age and Dose Subgroups. | Nepadutant was measured in the 24-h urine collection post both doses (0.1 and 0.5 mg/kg dose), in the age stratum 18-24 weeks, using urinary collection/extraction from pre-weighed special fiber based diapers. | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Adverse Events After Administration of Single Oral Doses up to 0.5 mg/kg of Nepadutant in Infants. | Number of adverse events (AE) reported by dose and age stratum 6-<12 and 12-<18 weeks. | one week |
| Number of Adverse Events After Administration of Single Oral Doses up to 0.5 mg/kg of Nepadutant in Infants. |
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Inclusion Criteria:
Subjects will be eligible for inclusion in the study if they meet all of the following criteria:
Exclusion Criteria:
Subjects will be excluded from the study if they meet any of the following criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey L Blumer, MD, PHD | Rainbow Babies and Children's Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arkansas Children's Hospital | Little Rock | Arkansas | 72202 | United States | ||
| Kosair Charities Pediatric Clinical Rsearch Unit University of Louisville |
Twenty out of the 21 enrolled infants were treated with study medication (1 infant did not attend the clinic after screening). NOTE: although the goal was to enroll 24 subjects, slow subject enrollment and expired drug restricted enrollment to 20 subjects
The recruitment period extended from March 2008 to May 2009 at three Hospital Clinics
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| ID | Title | Description |
|---|---|---|
| FG000 | Nepadutant 0.1 mg/kg | Nepadutant 0.1 mg/kg |
| FG001 | Nepadutant 0.5 mg/kg | Nepadutant 0.5 mg/kg |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Nepadutant 0.1 mg/kg | Nepadutant 0.1 mg/kg |
| BG001 | Nepadutant 0.5 mg/kg | Nepadutant 0.5 mg/kg |
| 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 | Drug Concentration Measurement in the Urine Collected by Diapers Along 24 Hours Post Dose and One Week After Dose in All Treated Infants and by Age and Dose Subgroups. | Nepadutant was measured in the 24-h urine collection post both doses (0.1 and 0.5 mg/kg dose), in the age strata 6-<12 and 12-<18 weeks, using urinary collection/extraction from pre-weighed special fiber based diapers. | Urinary drug concentration was analysed by dose and age stratum of the infants (6-<12 and 12- <18 weeks of age). Imputation technique was adopted for urine samples highly contaminated by faeces. | Posted | Mean | Standard Deviation | ng | 24 hours |
|
Adverse events were recorded after 24 hours after dosing and at 1 week final follow up.
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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 | Nepadutant 0.1 mg/kg | Nepadutant 0.1 mg/kg |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| diarrhoea | Gastrointestinal disorders | MedDRA 9.0 | Non-systematic Assessment | mild, possibly tretment related, 2 days after dosing lasting < 1 day |
No infants aged 18-24 weeks were dosed at 0.5 mg/kg dose when the trial was stopped because of slow recruitment and drug expiration.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Angela Capriati, Clinical research Director | Menarini Group- Clinical Research | + 39-055 56809990 | acapriati@menarini-ricerche.it |
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| ID | Term |
|---|---|
| D003085 | Colic |
| D015746 | Abdominal Pain |
| D005767 | Gastrointestinal Diseases |
| ID | Term |
|---|---|
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| C107754 | MEN 11420 |
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| Nepadutant | Drug | 0.5 mg/Kg as one single oral dose divided in three age strata (from 6 to 24 weeks old) |
|
Number of adverse events (AE) reported by dose and age stratum 18-24 weeks. |
| one week |
| Louisville |
| Kentucky |
| 40202 |
| United States |
| Rainbow Babies and Children's Hospital | Cleveland | Ohio | 44106 | United States |
| BG002 |
| Total |
Total of all reporting groups |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Nepadutant 0.5 mg/kg |
|
|
| Secondary | Number of Adverse Events After Administration of Single Oral Doses up to 0.5 mg/kg of Nepadutant in Infants. | Number of adverse events (AE) reported by dose and age stratum 6-<12 and 12-<18 weeks. | Number of adverse events by dose and age strata (6-<12 and 12- <18 weeks of age) are reported by system organ class and preferred term. | Posted | Number | Adverse Events | one week |
|
|
|
| Primary | Drug Concentration Measurement in the Urine Collected by Diapers Along 24 Hours Post Dose and One Week After Dose in All Treated Infants and by Age and Dose Subgroups. | Nepadutant was measured in the 24-h urine collection post both doses (0.1 and 0.5 mg/kg dose), in the age stratum 18-24 weeks, using urinary collection/extraction from pre-weighed special fiber based diapers. | Urinary drug concentration was analysed by dose and age stratum of the infants (18-24 weeks of age). Imputation technique was adopted for urine samples highly contaminated by faeces. | Posted | Mean | Standard Deviation | ng | 24 hours |
|
|
|
| Secondary | Number of Adverse Events After Administration of Single Oral Doses up to 0.5 mg/kg of Nepadutant in Infants. | Number of adverse events (AE) reported by dose and age stratum 18-24 weeks. | Number of adverse events by dose and age stratum (18-24 weeks of age) are reported by system organ class and preferred term. | Posted | Number | Adverse Events | one week |
|
|
|
| 0 |
| 12 |
| 4 |
| 12 |
| EG001 | Nepadutant 0.5 mg/kg | Nepadutant 0.5 mg/kg | 0 | 8 | 2 | 8 |
|
| vomiting | Gastrointestinal disorders | MedDRA 9.0 | Non-systematic Assessment | mild, unlikely treatment related |
|
| hard stools | Gastrointestinal disorders | MedDRA 9.0 | Non-systematic Assessment | mild, possibly treatment related, 2 hours post dosing and lasting up to the following day |
|
| pyrexia | General disorders | MedDRA 9.0 | Non-systematic Assessment | mild, unlikely treatment related |
|
| dermatitis by diaper | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Non-systematic Assessment | mild, unlikely treatment related |
|
| middle ear infection | Ear and labyrinth disorders | MedDRA 9.0 | Non-systematic Assessment | mild, unlikely treatment related |
|
| cough | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Non-systematic Assessment | mild, unlikely treatment related |
|
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| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012817 | Signs and Symptoms, Digestive |
| D004066 | Digestive System Diseases |