Trial · NCT01210352
Outcomes41
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 41
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Pain Intensity Score of Oxymorphone IR Oral Liquid in Pediatric Subjects by Age Group and Time Points in Single Dose Phase | Baseline, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post dose; and at the time of rescue | Effectiveness Population. The analyses performed for this study report did not differentiate the pain intensity and pain intensity difference by age/dose combination.~The analyses were conducted by age group alone and results are presented accordingly. | score on a scale | MEAN |
| PRIMARY | Descriptive Statistics of the Pain Intensity Difference (PID) by Age Group and Time Points in Single-Dose Phase | Baseline (prior to dose); 15, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose; and at the time of rescue | Effectiveness Population. The analyses performed for this study report did not differentiate the pain intensity and pain intensity difference by age/dose combination.~The analyses were conducted by age group alone and results are presented accordingly. | score on a scale | MEAN |
| PRIMARY | Pain Intensity Score of Oxymorphone IR Oral Liquid in Pediatric Subjects by Age Group and Time Points in Multiple Dose Phase | Baseline, 0.5, 1, 1.5, 2, hours post dose, and immediately prior to all remaining doses administered through 48 hours after administration of the initial dose; and at time of rescue | Effectiveness Population. Based on the recommendation of the Independent Data Monitoring Committee (IDMC), there was only 1 dose group of 0.2 mg/kg administered during the Multiple-dose Phase. Thus, this outcome measure was only assessed in this dose group. | score on a scale | MEAN |
| PRIMARY | Descriptive Statistics of Pain Intensity Difference (PID) by Age Group and Time Points in Multiple-Dose Phase | 0.5, 1, 1.5, 2, hours post dose 1 through to Dose 12, 0 Hour; End of Study/Early Termination | Effectiveness Population.IDMC recommended dose: 0.20 mg/kg oxymorphone HCl oral solution for the Multiple-dose Phase. Therefore, the analyses were conducted in a total of 16 subjects ranging from 2 to ≤12 years who received the dose of 0.20 mg/kg oxymorphone HCl oral solution as shown in the table of baseline characteristic in the participant flow. | score on a scale | MEAN |
| PRIMARY | Number (%) of Subjects With Rescue Medication Use by Age and Dose Group in Multiple-Dose Phase | Rescue Medication Use | Effectiveness Population.IDMC recommended dose: 0.20 mg/kg oxymorphone HCl oral solution for the Multiple-dose Phase. Therefore, the analyses were conducted in a total of 16 subjects ranging from 2 to ≤12 years who received the dose of 0.20 mg/kg oxymorphone HCl oral solution as shown in the table of baseline characteristic in the participant flow. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Oxymorphone Cmax Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase | Serial blood samples were collected at time 0 (Baseline), at 15 and 30 minutes, and at 1, 1.5, 2, 4, 6, 8, 12, and 24 hours post-dose | PK Population (only including subjects with sufficient evaluable time points for this outcome measure). | ng/mL | MEAN |
| SECONDARY | Oxymorphone Tmax Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase | Serial blood samples were collected at time 0 (Baseline), at 15 and 30 minutes, and at 1, 1.5, 2, 4, 6, 8, 12, and 24 hours post-dose | PK Population (only including subjects with sufficient evaluable time points for this outcome measure). | h | MEAN |
| SECONDARY | Oxymorphone Clast Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase | Serial blood samples were collected at time 0 (Baseline), at 15 and 30 minutes, and at 1, 1.5, 2, 4, 6, 8, 12, and 24 hours post-dose | PK Population (only including subjects with sufficient evaluable time points for this outcome measure). | ng/mL | MEAN |
| SECONDARY | Oxymorphone Tlast Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase | Serial blood samples were collected at time 0 (Baseline), at 15 and 30 minutes, and at 1, 1.5, 2, 4, 6, 8, 12, and 24 hours post-dose | PK Population (only including subjects with sufficient evaluable time points for this outcome measure). | h | MEAN |
| SECONDARY | Oxymorphone AUC0-t Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase | Serial blood samples were collected at time 0 (Baseline), at 15 and 30 minutes, and at 1, 1.5, 2, 4, 6, 8, 12, and 24 hours post-dose | PK Population (only including subjects with sufficient evaluable time points for this outcome measure). | h*ng/mL | MEAN |
| SECONDARY | Oxymorphone AUC0-inf Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase | Serial blood samples were collected at time 0 (Baseline), at 15 and 30 minutes, and at 1, 1.5, 2, 4, 6, 8, 12, and 24 hours post-dose | PK Population (only including subjects with sufficient evaluable time points for this outcome measure). | h*ng/mL | MEAN |
| SECONDARY | Oxymorphone AUC0-24 Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase | Serial blood samples were collected at time 0 (Baseline), at 15 and 30 minutes, and at 1, 1.5, 2, 4, 6, 8, 12, and 24 hours post-dose | PK Population (only including subjects with sufficient evaluable time points for this outcome measure). | h*ng/mL | MEAN |
| SECONDARY | Oxymorphone t1/2 Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase | Serial blood samples were collected at time 0 (Baseline), at 15 and 30 minutes, and at 1, 1.5, 2, 4, 6, 8, 12, and 24 hours post-dose | PK Population (only including subjects with sufficient evaluable time points for this outcome measure). | h | MEAN |
| SECONDARY | Dose-Normalized Oxymorphone CL/F Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase | Serial blood samples were collected at time 0 (Baseline), at 15 and 30 minutes, and at 1, 1.5, 2, 4, 6, 8, 12, and 24 hours post-dose | PK Population (subjects with sufficient plasma concentration data to calculate PK parameter values). Since the overall exposure (AUC 0 to t) increased in near dose proportional manner, PK parameter values were dose normalized across all dose levels for each age group to determine the CL/F. | L/h/kg | MEAN |
| SECONDARY | Dose-Normalized Oxymorphone V/F Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase | Serial blood samples were collected at time 0 (Baseline), at 15 and 30 minutes, and at 1, 1.5, 2, 4, 6, 8, 12, and 24 hours post-dose | PK Population (subjects with sufficient plasma concentration data to calculate PK parameter values). Since the overall exposure (AUC 0 to t) increased in near dose proportional manner, PK parameter values were dose normalized across all dose levels for each age group to determine the V/F. | L/kg | MEAN |
| SECONDARY | Oxymorphone Cmax Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7 | Serial blood samples were collected at: time 0 (Baseline), at 0.5, 1, 1.5, and 2 hours post-Dose 1, immediately prior to Doses 2, 3, 4, 5, 6, 7, and at 0.5, 1, 1.5, and 2 hours post-Dose 7 | Analysis was conducted in the PK Population with sufficient concentration data at required time points. During the Multiple-dose Phase, all subjects received 0.2 mg/kg oxymorphone HCl IR solution. Analysis of Cmax was conducted in the subjects remaining in the study, with sufficient concentration data at the required time points, as shown. | ng/mL | MEAN |
| SECONDARY | Oxymorphone Tmax Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7 | Serial blood samples were collected at: time 0 (Baseline), at 0.5, 1, 1.5, and 2 hours post-Dose 1, immediately prior to Doses 2, 3, 4, 5, 6, 7, and at 0.5, 1, 1.5, and 2 hours post-Dose 7 | Analysis was conducted in the PK Population with sufficient concentration data at required time points. During the Multiple-dose Phase, all subjects received 0.2 mg/kg oxymorphone HCl IR solution. Analysis of Tmax was conducted in the subjects remaining in the study, with sufficient concentration data at the required time points, as shown. | h | MEAN |
| SECONDARY | Oxymorphone Clast Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7 | Serial blood samples were collected at: time 0 (Baseline), at 0.5, 1, 1.5, and 2 hours post-Dose 1, immediately prior to Doses 2, 3, 4, 5, 6, 7, and at 0.5, 1, 1.5, and 2 hours post-Dose 7 | Analysis was conducted in the PK Population with sufficient concentration data at required time points. During the Multiple-dose Phase, all subjects received 0.2 mg/kg oxymorphone HCl IR solution. Analysis of Clast was conducted in the subjects remaining in the study, with sufficient concentration data at the required time points, as shown. | ng/mL | MEAN |
| SECONDARY | Oxymorphone Tlast Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7 | Serial blood samples were collected at: time 0 (Baseline), at 0.5, 1, 1.5, and 2 hours post-Dose 1, immediately prior to Doses 2, 3, 4, 5, 6, 7, and at 0.5, 1, 1.5, and 2 hours post-Dose 7 | Analysis was conducted in the PK Population with sufficient concentration data at required time points. During the Multiple-dose Phase, all subjects received 0.2 mg/kg oxymorphone HCl IR solution. Analysis of Tlast was conducted in the subjects remaining in the study, with sufficient concentration data at the required time points, as shown. | h | MEAN |
| SECONDARY | Oxymorphone AUC0-t Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7 | Serial blood samples were collected at: time 0 (Baseline), at 0.5, 1, 1.5, and 2 hours post-Dose 1, immediately prior to Doses 2, 3, 4, 5, 6, 7, and at 0.5, 1, 1.5, and 2 hours post-Dose 7 | Analysis was conducted in the PK Population with sufficient concentration data at required time points. During the Multiple-dose Phase, all subjects received 0.2 mg/kg oxymorphone HCl IR solution. Analysis of AUC0-t was conducted in the subjects remaining in the study, with sufficient concentration data at the required time points, as shown. | h*ng/mL | MEAN |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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