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Open-Label Safety and Tolerability Study of Oxymorphone for Acute Postoperative Pain in Pediatric Subjects.

Primary Purpose

Postoperative Pain

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Oxymorphone IR

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring Opioid tolerant, Pediatric, Pain, Non malignant, Malignant

Eligibility Criteria

12 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Male or female > 12 to 17 years of age, inclusive
Weigh at least 50 kg
Postoperative oral opioid analgesia required for at least 24 hours or 48 hours following postoperataive parenteral analgesia
Are expected to be hospitalized for the duration of the study

Exclusion Criteria:

Known allergy to, or a significant reaction to, oxymorphone or another opioid
Life expectancy of < 4 weeks
Positive pregnancy test at screening

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Oxymorphone IR

Arm Description

Open-Label, 2 part ascending-dose multicenter study

Outcomes

Primary Outcome Measures

Summary of Visual Analog Scales (VAS) of Pain Intensity Change From Baseline by Treatment Group With Single Dose of Oxymorphone IR Tablet and Multiple Dose of Oxymorphone IR Tablet

Change from Baseline in 100-mm Visual Analog Scales (VAS) in Multiple Dose of Oxymorphone IR Tablet

Subjects Taking Rescue Medication

Percentages are based on the number of subjects in each treatment group.

Secondary Outcome Measures

AUC(0-t) of Single Dose of Oxymorphone by Treatment Group

AUC0-t: Area under the concentration versus time curve from time 0 to the last measured concentration (Ct), calculated by linear trapezoidal rule

AUC(0-inf) of Single Dose of Oxymorphone by Treatment Group

AUC0-inf: Area under the concentration versus time curve from time 0 to infinity, calculated as AUC0-t + Ct/terminal rate constant (single-dose period only), where Ct is the concentration at the time of the last quantifiable concentration

Cmax of Single Dose of Oxymorphone by Treatment Group

Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval

Tmax of Single Dose of Oxymorphone by Treatment Group

Tmax: The time at which Cmax was observed

Terminal Rate Constant of Single Dose of Oxymorphone by Treatment Group

λ: Terminal rate constant, calculated as the negative slope of the ln-linear portion of the terminal plasma concentration-time curve (single-dose period only)

Terminal Half-life of Single Dose of Oxymorphone by Treatment Group

t½: Terminal half-life, calculated as terminal rate constant/(ln 2) (single-dose period only)

Full Information

NCT ID

NCT00801398

First Posted

December 2, 2008

Last Updated

February 1, 2019

Sponsor

Endo Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT00801398

Brief Title

Open-Label Safety and Tolerability Study of Oxymorphone for Acute Postoperative Pain in Pediatric Subjects.

Official Title

An Open-Label, Ascending, Two-Part, Single- and Multiple-Dose Evaluation of the Safety, Pharmacokinetics, and Effectiveness of Oxymorphone for Acute Postoperatiave Pain in Pediatric Subjects

Study Type

Interventional

2. Study Status

Record Verification Date

December 2018

Overall Recruitment Status

Completed

Study Start Date

February 17, 2009 (Actual)

Primary Completion Date

April 18, 2011 (Actual)

Study Completion Date

April 18, 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Endo Pharmaceuticals

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

When post-operative parenteral analgesia is discontinued, oral dosing with study medication may begin once the subject has developed a moderate level of pain as defined by a 100 mm VAS (pain intensity score greater than or equal to 40). This post marketing study was required by the FDA. Endo Pharmaceuticals Inc. no longer promotes opioids and no longer markets Opana® ER.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postoperative Pain

Keywords

Opioid tolerant, Pediatric, Pain, Non malignant, Malignant

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

58 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Oxymorphone IR

Arm Type

Experimental

Arm Description

Open-Label, 2 part ascending-dose multicenter study

Intervention Type

Drug

Intervention Name(s)

Oxymorphone IR

Other Intervention Name(s)

Opana IR

Intervention Description

Open-label, 2 part, ascending dose, single and multiple dose q4-6 hrs up to 48 hrs

Primary Outcome Measure Information:

Title

Summary of Visual Analog Scales (VAS) of Pain Intensity Change From Baseline by Treatment Group With Single Dose of Oxymorphone IR Tablet and Multiple Dose of Oxymorphone IR Tablet

Description

Change from Baseline in 100-mm Visual Analog Scales (VAS) in Multiple Dose of Oxymorphone IR Tablet

Time Frame

Single Dose Timeframe: 15min, 30min, 1h, 2h, 3h, 4h, 6h or Rescue; Multiple Dose Timeframe: 15min, 30min, 1h, 2h, 3h, 4h, 6h, subsequent doses every 4-6 hours (Multiple Dose #1-11), and Early Termination

Title

Subjects Taking Rescue Medication

Description

Percentages are based on the number of subjects in each treatment group.

Time Frame

first dose through 48 hours after first dose

Secondary Outcome Measure Information:

Title

AUC(0-t) of Single Dose of Oxymorphone by Treatment Group

Description

AUC0-t: Area under the concentration versus time curve from time 0 to the last measured concentration (Ct), calculated by linear trapezoidal rule

Time Frame