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The present pilot study is aimed to obtain preliminary data on the effect of three ascending oral dose levels of nepadutant on the relief of symptoms associated with feeding intolerance. In addition, the assessment of drug exposure (PK assessment) will provide additional information on the dose-effect relationship, thus supporting the dose selection and dosing schedule in the future studies.
Feeding intolerance is a transient neuro-developmental phenomenon affecting 25% to 40% of infant and toddler, with a peak at 6 weeks of age. Feeding problems include mainly vomiting, slow feeding, refusal to eat and colic.
Current non pharmacological interventions (e.g. message, restriction in maternal diet in breast-feeding infants) and pharmacological treatments (simethicone, antimuscarinic drugs and antiacids) are largely unsatisfactory.
Nepadutant is postulated to have a therapeutic effect in infant colic since it reverts exaggerated intestinal motility and sensitivity induced by different stimuli through the activation of neurokinin-2 receptors, without interferring on the on physiological gastrointestinal transit.
This phase IIa study is designed to test in each participant infant two out of three oral doses of nepadutant in order to measure its blood levels, safety and efficacy with each dose level to be given for 7 concecutive days.
The experimental clinical phase encompasses the following periods:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 3 | Experimental | Nepadutant low dose (0.1mg/kg) for 7 days followed by Nepadutant high dose (1mg/kg) for additional 7 days |
|
| Cohort 2 | Experimental | Nepadutant medium dose (0.5mg/kg) for 7 days followed by Nepadutant high dose (1mg/kg) for additional 7 days |
|
| Cohort 1 | Experimental | Nepadutant low dose (0.1mg/kg) for 7 days followed by Nepadutant medium dose (0.5mg/kg) for additional 7 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nepadutant | Drug | Nepadutant oral solution |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Absolute Differences of I-GERQ-R Total Score at V3 (End of First Week of Treatment) Respect to the Baseline (V2). | Results obtained at V2 serve as baseline values for the assessment of effects at V3 (i.e. end of first week of treatment). Infant Gastroesophageal Reflux Questionnaire Revised (I-GERQ-R ), with a minimum-maximum score of 0-42 (minimum for diagnosis >15). The higher values reflect worse outcome. The questionnaire comprised 12 items as questions quantifying aspects of regurgitation (3 questions), crying (3 questions), feeding refusal (2 questions), apnea/cyanosis (2 questions), hiccups and arching. Questions with 4 possible options have a score ranging from 0 to 3; questions with 5 possible options have a score ranging from 0 to 4. The scores of each item are summed, so the total score is presented. | Baseline (V2) and end of first week of treatment (V3) |
| The Absolute Differences of I-GERQ-R Total Score at V4 (End of 2nd Week of Treatment) Respect to V3 (End of 1st Week of Treatment). | The results obtained at V3 are used as baseline for the second week treatment period (V4). Infant Gastroesophageal Reflux Questionnaire Revised (I-GERQ-R ), with a minimum-maximum score of 0-42 (minimum for diagnosis >15). The higher values reflect worse outcome. The questionnaire comprised 12 items as questions quantifying aspects of regurgitation (3 questions), crying (3 questions), feeding refusal (2 questions), apnea/cyanosis (2 questions), hiccups and arching. Questions with 4 possible options have a score ranging from 0 to 3; questions with 5 possible options have a score ranging from 0 to 4. The scores of each item are summed, so the total score is presented. | V3 (end of 1st week of treatment) and V4 (end of 2nd week of treatment) |
| The Absolute Differences of I-GERQ-R Total Score at V5 (Follow-up) Respect to V2 (Baseline). | Results obtained at V2 serve as baseline values for follow-up assessment 2 weeks after the last administered dose (V5) Infant Gastroesophageal Reflux Questionnaire Revised (I-GERQ-R ), with a minimum-maximum score of 0-42 (minimum for diagnosis >15). The higher values reflect worse outcome. The questionnaire comprised 12 items as questions quantifying aspects of regurgitation (3 questions), crying (3 questions), feeding refusal (2 questions), apnea/cyanosis (2 questions), hiccups and arching. Questions with 4 possible options have a score ranging from 0 to 3; questions with 5 possible options have a score ranging from 0 to 4. The scores of each item are summed, so the total score is presented. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and Severity of AEs_ Number of Adverse Events by Treatment Dose Level | The analysis is by treatment - Each infant was treated with two out of three ascending dose (0.1, 0.5 or 1.0 mg/kg), therefore counted in more than one dose level. | up to 4 weeks |
| A Population Pharmacokinetic Analysis to Characterize the Plasma Concentration-time Course for Nepadutant in Infant With Colics From NIC-04 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey L Blumer, MD, PhD | The University of Toledo Medical Center 3000 Arlington Avenue, Toledo OH 43614 USA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arkansas Children's Hospital | Little Rock | Arkansas | 72202 | United States | ||
| Children's Center for Digestive Healthcare |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 3 | Nepadutant low dose (0.1mg/kg) for 7 days followed by Nepadutant high dose (1mg/kg) for additional 7 days Nepadutant: Nepadutant oral solution |
| FG001 | Cohort 2 | Nepadutant medium dose (0.5mg/kg) for 7 days followed by Nepadutant high dose (1mg/kg) for additional 7 days Nepadutant: Nepadutant oral solution |
| FG002 | Cohort 1 | Nepadutant low dose (0.1mg/kg) for 7 days followed by Nepadutant medium dose (0.5mg/kg) for additional 7 days Nepadutant: Nepadutant oral solution |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Infants with Feeding Intolerance
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 3 | Nepadutant low dose (0.1mg/kg) for 7 days followed by Nepadutant high dose (1mg/kg) for additional 7 days Nepadutant: Nepadutant oral solution |
| BG001 | Cohort 2 | Nepadutant medium dose (0.5mg/kg) for 7 days followed by Nepadutant high dose (1mg/kg) for additional 7 days Nepadutant: Nepadutant oral solution |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age is in weeks (PGA: post gestational age) |
| 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 | The Absolute Differences of I-GERQ-R Total Score at V3 (End of First Week of Treatment) Respect to the Baseline (V2). | Results obtained at V2 serve as baseline values for the assessment of effects at V3 (i.e. end of first week of treatment). Infant Gastroesophageal Reflux Questionnaire Revised (I-GERQ-R ), with a minimum-maximum score of 0-42 (minimum for diagnosis >15). The higher values reflect worse outcome. The questionnaire comprised 12 items as questions quantifying aspects of regurgitation (3 questions), crying (3 questions), feeding refusal (2 questions), apnea/cyanosis (2 questions), hiccups and arching. Questions with 4 possible options have a score ranging from 0 to 3; questions with 5 possible options have a score ranging from 0 to 4. The scores of each item are summed, so the total score is presented. | Infants with feeding intolerance who received at least 1 dose of nepadutant. In the 3rd cohort 1 subject didn't report I-GERQ-R score at randomization. In the 1rst cohort 1 patient early terminated after V2. | Posted | Mean | Standard Deviation | score on a scale | Baseline (V2) and end of first week of treatment (V3) |
|
4 weeks
Analysed for the Safety Population (all patients who received the study drug) The analysis is by treatment - Each infant was treated with two out of three ascending dose (0.1, 0.5 or 1.0 mg/kg), therefore counted in more than one dose level.
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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 | High Dose Level (1.0 mg/Kg) | Subjects who received at least 1 dose of nepadutant 1.0mg/kg (Subjects who took Nepadutant 1.0 mg/dl for the additional 7 days - coming from Nepadutant 0.1 mg/kg and 0.5 mg/kg) Nepadutant: Nepadutant oral solution |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalisation for investigation for suspected seizures | Surgical and medical procedures | MedRA | Systematic Assessment | 10 wks-old male-familiar history of seizure disorders.It started 6days after the last drug intake (nepadutant 0.1mg/kg early terminate after 3drug intakes).It reported as "moderate","not related" to nepadutant by investigator. It resolved: no sequel. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedRA | Systematic Assessment |
Study performed in a small number of subjects.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Angela Capriati | Menarini Ricerche | +39 05556809990 | acapriati@menarini-ricerche.it |
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| ID | Term |
|---|---|
| D003085 | Colic |
| ID | Term |
|---|---|
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| C107754 | MEN 11420 |
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| Baseline (V2) and follow up 2 weeks after the last administered dose (V5) |
| I-GERQ-R Score Changes vs Baseline (Visit 2) by First Dose Level (0.1mg/kg and 0.5mg/kg). | Change in Infant Gastroesophageal Reflux Questionnaire Revised (I-GERQ-R) Score. Assessing the I-GERQ-R score changes vs baseline (Visit 2) by first dose level (0.1mg/kg and 0.5mg/kg). Infant Gastroesophageal Reflux Questionnaire Revised (I-GERQ-R ), with a minimum-maximum score of 0-42 (minimum for diagnosis >15). The higher values reflect worse outcome. The questionnaire comprised 12 items as questions quantifying aspects of regurgitation (3 questions), crying (3 questions), feeding refusal (2 questions), apnea/cyanosis (2 questions), hiccups and arching. Questions with 4 possible options have a score ranging from 0 to 3; questions with 5 possible options have a score ranging from 0 to 4. The scores of each item are summed, so the total score is presented. | Baseline (V2) and end of 1st week of treatment(V3) |
| I-GERQ-R Score Changes vs Visit 3 by Second Dose Level (0.5mg/kg and 1mg/kg). | Change in Infant Gastroesophageal Reflux Questionnaire Revised (I-GERQ-R) Score. Assessing the I-GERQ-R score changes vs Visit 3 by second dose level (0.5mg/kg and 1mg/kg). Infant Gastroesophageal Reflux Questionnaire Revised (I-GERQ-R ), with a minimum-maximum score of 0-42 (minimum for diagnosis >15). The higher values reflect worse outcome. The questionnaire comprised 12 items as questions quantifying aspects of regurgitation (3 questions), crying (3 questions), feeding refusal (2 questions), apnea/cyanosis (2 questions), hiccups and arching. Questions with 4 possible options have a score ranging from 0 to 3; questions with 5 possible options have a score ranging from 0 to 4. The scores of each item are summed, so the total score is presented. | end of first week of treatment (V3) and end of second week of treatment (V4) |
The population pharmacokinetic analyses is presented. PopPK Clearance estimated with a one compartment model with first order absorption and elimination. |
| 0.5, 1, 2, 3 hours post Single Dose and 24 hours post Repeated Dose |
| A Population Pharmacokinetic Analysis to Characterize the Plasma Concentration-time Course for Nepadutant in Infant With Colics From NIC-04 | PopPK Volume estimated with a one compartment model with first order absorption and elimination. NOTE: for this measure, no inter-individual variability was estimated, therefore the value for each cohort corresponds to the typical value. | 0.5, 1, 2, 3 hours post Single Dose and 24 hours post Repeated Dose |
| A Population Pharmacokinetic Analysis to Characterize the Plasma Concentration-time Course for Nepadutant in Infant With Colics From NIC-04 | The population pharmacokinetic analyses is presented. PopPK Ka estimated with a one compartment model with first order absorption and elimination. NOTE: for this measure, no inter-individual variability was estimated, therefore the value for each cohort corresponds to the typical value. | 0.5, 1, 2, 3 hours post Single Dose and 24 hours post Repeated Dose |
| A Population Pharmacokinetic Analysis to Characterize the Plasma Concentration-time Course for Nepadutant in Infant With Colics From NIC-04 | The population pharmacokinetic analyses is presented. The PopPK parameter fraction of the dose absorbed (F1) is estimated with a one compartment model with first order absorption and elimination.The results are presented fraction of the absorbed dose with 95% CI of the parameter estimate value | 0.5, 1, 2, 3 hours post Single Dose and 24 hours post Repeated Dose |
| Atlanta |
| Georgia |
| 30342 |
| United States |
| Kosair Charities Pediatric Clinical Research Unit / University of Louisville | Louisville | Kentucky | 40202 | United States |
| SUNY Downstate Medical Center | Albany | New York | 12207 | United States |
| The University of Toledo College of Medicine\The Toledo Children's Hospital | Toledo | Ohio | 43606 | United States |
| BG002 | Cohort 1 | Nepadutant low dose (0.1mg/kg) for 7 days followed by Nepadutant medium dose (0.5mg/kg) for additional 7 days Nepadutant: Nepadutant oral solution |
| BG003 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| weeks |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | particpants |
|
| Region of Enrollment | Number | participants |
|
| Weight | Mean | Standard Deviation | Kg |
|
| I-GERQ-R total score | Infant Gastroesophageal Reflux Questionnaire Revised (I-GERQ-R ), with a minimum-maximum score of 0-42 (minimum for diagnosis >15). The higher values reflect worse outcome. The questionnaire comprised 12 items as questions quantifying aspects of regurgitation (3 questions), crying (3 questions), feeding refusal (2 questions), apnea/cyanosis (2 questions), hiccups and arching. Questions with 4 possible options have a score ranging from 0 to 3; questions with 5 possible options have a score ranging from 0 to 4. The scores of each item are summed, so the total score is presented. | Mean | Standard Deviation | Score on a scale |
|
| Description |
|---|
| OG000 | Cohort 3 | Nepadutant low dose (0.1mg/kg) for 7 days followed by Nepadutant high dose (1mg/kg) for additional 7 days Nepadutant: Nepadutant oral solution |
| OG001 | Cohort 2 | Nepadutant medium dose (0.5mg/kg) for 7 days followed by Nepadutant high dose (1mg/kg) for additional 7 days Nepadutant: Nepadutant oral solution |
| OG002 | Cohort 1 | Nepadutant low dose (0.1mg/kg) for 7 days followed by Nepadutant medium dose (0.5mg/kg) for additional 7 days Nepadutant: Nepadutant oral solution |
|
|
| Primary | The Absolute Differences of I-GERQ-R Total Score at V4 (End of 2nd Week of Treatment) Respect to V3 (End of 1st Week of Treatment). | The results obtained at V3 are used as baseline for the second week treatment period (V4). Infant Gastroesophageal Reflux Questionnaire Revised (I-GERQ-R ), with a minimum-maximum score of 0-42 (minimum for diagnosis >15). The higher values reflect worse outcome. The questionnaire comprised 12 items as questions quantifying aspects of regurgitation (3 questions), crying (3 questions), feeding refusal (2 questions), apnea/cyanosis (2 questions), hiccups and arching. Questions with 4 possible options have a score ranging from 0 to 3; questions with 5 possible options have a score ranging from 0 to 4. The scores of each item are summed, so the total score is presented. | Infants with feeding intolerance who received at least 1 dose of nepadutant. In the 3rd cohort 1 subject didn't report I-GERQ-R score at randomization. In the 1rst cohort 1 patient early terminated after V2. | Posted | Mean | Standard Deviation | Score as sum of units | V3 (end of 1st week of treatment) and V4 (end of 2nd week of treatment) |
|
|
|
| Primary | The Absolute Differences of I-GERQ-R Total Score at V5 (Follow-up) Respect to V2 (Baseline). | Results obtained at V2 serve as baseline values for follow-up assessment 2 weeks after the last administered dose (V5) Infant Gastroesophageal Reflux Questionnaire Revised (I-GERQ-R ), with a minimum-maximum score of 0-42 (minimum for diagnosis >15). The higher values reflect worse outcome. The questionnaire comprised 12 items as questions quantifying aspects of regurgitation (3 questions), crying (3 questions), feeding refusal (2 questions), apnea/cyanosis (2 questions), hiccups and arching. Questions with 4 possible options have a score ranging from 0 to 3; questions with 5 possible options have a score ranging from 0 to 4. The scores of each item are summed, so the total score is presented. | Infants with feeding intolerance who received at least 1 dose of nepadutant. In the 3rd cohort 1 subject didn't report I-GERQ-R score at randomization. In the 1rst cohort 1 patient early terminated after V2. | Posted | Mean | Standard Deviation | Score as sum of units | Baseline (V2) and follow up 2 weeks after the last administered dose (V5) |
|
|
|
| Primary | I-GERQ-R Score Changes vs Baseline (Visit 2) by First Dose Level (0.1mg/kg and 0.5mg/kg). | Change in Infant Gastroesophageal Reflux Questionnaire Revised (I-GERQ-R) Score. Assessing the I-GERQ-R score changes vs baseline (Visit 2) by first dose level (0.1mg/kg and 0.5mg/kg). Infant Gastroesophageal Reflux Questionnaire Revised (I-GERQ-R ), with a minimum-maximum score of 0-42 (minimum for diagnosis >15). The higher values reflect worse outcome. The questionnaire comprised 12 items as questions quantifying aspects of regurgitation (3 questions), crying (3 questions), feeding refusal (2 questions), apnea/cyanosis (2 questions), hiccups and arching. Questions with 4 possible options have a score ranging from 0 to 3; questions with 5 possible options have a score ranging from 0 to 4. The scores of each item are summed, so the total score is presented. | Subjects with feeding intolerance who received at least 1 dose of nepadutant (first dose level 0.1mg/kg and 0.5 mg/kg). One subject in the 3rd cohort didn't report I-GERQ-R score at V2. | Posted | Mean | Standard Deviation | score on a scale | Baseline (V2) and end of 1st week of treatment(V3) |
|
|
|
| Primary | I-GERQ-R Score Changes vs Visit 3 by Second Dose Level (0.5mg/kg and 1mg/kg). | Change in Infant Gastroesophageal Reflux Questionnaire Revised (I-GERQ-R) Score. Assessing the I-GERQ-R score changes vs Visit 3 by second dose level (0.5mg/kg and 1mg/kg). Infant Gastroesophageal Reflux Questionnaire Revised (I-GERQ-R ), with a minimum-maximum score of 0-42 (minimum for diagnosis >15). The higher values reflect worse outcome. The questionnaire comprised 12 items as questions quantifying aspects of regurgitation (3 questions), crying (3 questions), feeding refusal (2 questions), apnea/cyanosis (2 questions), hiccups and arching. Questions with 4 possible options have a score ranging from 0 to 3; questions with 5 possible options have a score ranging from 0 to 4. The scores of each item are summed, so the total score is presented. | Subjects with feeding intolerance who received at least 1 dose of nepadutant (second dose level 0.5mg/kg and 1 mg/kg) 1 subject in the first cohort early terminated after V2 | Posted | Mean | Standard Deviation | Score as sum of units | end of first week of treatment (V3) and end of second week of treatment (V4) |
|
|
|
| Secondary | Incidence and Severity of AEs_ Number of Adverse Events by Treatment Dose Level | The analysis is by treatment - Each infant was treated with two out of three ascending dose (0.1, 0.5 or 1.0 mg/kg), therefore counted in more than one dose level. | All subjects who received at least one administration of study treatment including dose tolerability test (safety population) | Posted | Number | Number of events | up to 4 weeks |
|
|
|
| Secondary | A Population Pharmacokinetic Analysis to Characterize the Plasma Concentration-time Course for Nepadutant in Infant With Colics From NIC-04 | The population pharmacokinetic analyses is presented. PopPK Clearance estimated with a one compartment model with first order absorption and elimination. | At visit 2, samples from 12 subjects in 0.1 mg/kg and from 15 subjects in 0.5 mg/kg. At visit 3*, 4*: samples from 15 subjects in 0.1 - 0.5 mg/kg cohort, from 5 in 0.5 - 1 mg/kg cohort and from 6 in 0.1 - 1 mg/kg cohort. *N=26 instead of 27 as one patient early terminated the study | Posted | Mean | 95% Confidence Interval | L/h | 0.5, 1, 2, 3 hours post Single Dose and 24 hours post Repeated Dose |
|
|
|
| Secondary | A Population Pharmacokinetic Analysis to Characterize the Plasma Concentration-time Course for Nepadutant in Infant With Colics From NIC-04 | PopPK Volume estimated with a one compartment model with first order absorption and elimination. NOTE: for this measure, no inter-individual variability was estimated, therefore the value for each cohort corresponds to the typical value. | At visit 2, samples from 6 subjects in Cohort 1 at 0.1mg/kg; 6 subjects in Cohort 3 at 0,1 mg/kg; 15 subjects in Cohort 2 at 0.5 mg/kg. At visit 3*, 4*: samples from 5 subjects in Cohort 1 (0.1 - 0.5 mg/kg), 15 subjects in Cohort 2 (0.5 - 1 mg/kg) and 6 subjects in Cohort 3 (0.1 - 1 mg/kg). | Posted | Mean | Full Range | L | 0.5, 1, 2, 3 hours post Single Dose and 24 hours post Repeated Dose |
|
|
|
| Secondary | A Population Pharmacokinetic Analysis to Characterize the Plasma Concentration-time Course for Nepadutant in Infant With Colics From NIC-04 | The population pharmacokinetic analyses is presented. PopPK Ka estimated with a one compartment model with first order absorption and elimination. NOTE: for this measure, no inter-individual variability was estimated, therefore the value for each cohort corresponds to the typical value. | At visit 2, samples from 6 subjects in Cohort 1 at 0.1mg/kg; 6 subjects in Cohort 3 at 0,1 mg/kg; 15 subjects in Cohort 2 at 0.5 mg/kg. At visit 3*, 4*: samples from 5 subjects in Cohort 1 (0.1 - 0.5 mg/kg), 15 subjects in Cohort 2 (0.5 - 1 mg/kg) and 6 subjects in Cohort 3 (0.1 - 1 mg/kg). | Posted | Mean | Full Range | 1/h | 0.5, 1, 2, 3 hours post Single Dose and 24 hours post Repeated Dose |
|
|
|
| Secondary | A Population Pharmacokinetic Analysis to Characterize the Plasma Concentration-time Course for Nepadutant in Infant With Colics From NIC-04 | The population pharmacokinetic analyses is presented. The PopPK parameter fraction of the dose absorbed (F1) is estimated with a one compartment model with first order absorption and elimination.The results are presented fraction of the absorbed dose with 95% CI of the parameter estimate value | At visit 2, samples from 6 subjects in Cohort 1 at 0.1mg/kg; 6 subjects in Cohort 3 at 0,1 mg/kg; 15 subjects in Cohort 2 at 0.5 mg/kg. At visit 3*, 4*: samples from 5 subjects in Cohort 1 (0.1 - 0.5 mg/kg), 15 subjects in Cohort 2 (0.5 - 1 mg/kg) and 6 subjects in Cohort 3 (0.1 - 1 mg/kg). | Posted | Mean | 95% Confidence Interval | fraction of dose absorbed | 0.5, 1, 2, 3 hours post Single Dose and 24 hours post Repeated Dose |
|
|
|
| 1 |
| 21 |
| 12 |
| 21 |
| EG001 | Medium Dose Level (0.5mg/Kg) | Subjects who received at least 1 dose of nepadutant 0.5 mg/kg (subjects who took Nepadutant 0.5 mg/dl for the first 7 days AND subjects who took Nepadutant 0.5 mg/dl for the additional 7 days - coming from Neapdutant 0.1 mg/kg) Nepadutant: Nepadutant oral solution | 0 | 21 | 2 | 21 |
| EG002 | Low Dose Level(0.1mg/Kg) | Subjects who received at least 1 dose of nepadutant 0.1 mg/kg (subjects who took Nepadutant 0.1mg/dl for the first 7 days) Nepadutant: Nepadutant oral solution | 1 | 12 | 8 | 12 |
|
| Laryngeal Edema-post intubation | Respiratory, thoracic and mediastinal disorders | MedRA | Systematic Assessment | Prolongation of hospitalization due to post-intubation laryngeal edema in a 22wks-old female.It started 4days after the end of the 2weeks of treatment:it reported as "moderate","not related" to the treatment by investigators.It resolved:no sequel. |
|
| Diarrhoea | Gastrointestinal disorders | MedRA | Systematic Assessment |
|
| Teething | Gastrointestinal disorders | MedRA | Systematic Assessment |
|
| Ear infection | Infections and infestations | MedRA | Systematic Assessment |
|
| Viral infection | Infections and infestations | MedRA | Systematic Assessment |
|
| Dermatitis diaper | Skin and subcutaneous tissue disorders | MedRA | Non-systematic Assessment |
|
| Candidiasis | Infections and infestations | MedRA | Systematic Assessment |
|
| Screaming | Psychiatric disorders | MedRA | Systematic Assessment |
|
| Upper respiratory atract congestion | Respiratory, thoracic and mediastinal disorders | MedRA | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedRA | Systematic Assessment |
|
| Seborrhoic dermatitis | Skin and subcutaneous tissue disorders | MedRA | Systematic Assessment |
|
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between the Principal Investigator and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The results of the study cannot be submitted for presentation, abstract, poster exhibition, or publication by the investigator until Menarini Ricerche S.p.A.
has reviewed/commented and agreed to any publication.
|
| Infections and infestations |
|
| Injury, poisoning and procedural complications |
|
| Psychiatric disorders |
|
| Respiratory, thoracic and medistinal disorders |
|
| Skin and subcutaneous tissue disorders |
|