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

Postoperative Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00801398
• Other study ID #: EN3203-010
• Status: Completed
• Phase: Phase 3
• Start date: February 17, 2009
• Est. completion date: April 18, 2011

Study information

• Verified date: December 2018
• Source: Endo Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: April 18, 2011
• Est. primary completion date: April 18, 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Oxymorphone IR
Open-label, 2 part, ascending dose, single and multiple dose q4-6 hrs up to 48 hrs

Locations

Country	Name	City	State
United States	The Children's Hospital	Aurora	Colorado
United States	University of Texas Southwestern Medical Center at Dallas	Dallas	Texas
United States	Hershey Medical Center	Hershey	Pennsylvania
United States	Indiana University School of Medicine	Indianapolis	Indiana
United States	Arkansas Children's Hospital	Little Rock	Arkansas
United States	Monroe Carell Jr. Children's Hospital at Vanderbilt	Nashville	Tennessee
United States	The Children's Hospital of Pittsburgh	Pittsburgh	Pennsylvania
United States	University of Washington	Seattle	Washington
United States	Stanford University School of Medicine	Stanford	California
United States	St. Joseph's Children's Hospital of Tampa	Tampa	Florida
United States	Children's Research Institute	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Endo Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Primary	Subjects Taking Rescue Medication	Percentages are based on the number of subjects in each treatment group.	first dose through 48 hours after first dose
Secondary	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	Baseline, 2h, 4h, 8h, 12h, 24h, 28h, 32h, 36h and 48h
Secondary	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	Baseline, 2h, 4h, 8h, 12h, 24h, 28h, 32h, 36h and 48h
Secondary	Cmax of Single Dose of Oxymorphone by Treatment Group	Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval	Baseline, 2h, 4h, 8h, 12h, 24h, 28h, 32h, 36h and 48h
Secondary	Tmax of Single Dose of Oxymorphone by Treatment Group	Tmax: The time at which Cmax was observed	Baseline, 2h, 4h, 8h, 12h, 24h, 28h, 32h, 36h and 48h
Secondary	Terminal Rate Constant of Single Dose of Oxymorphone by Treatment Group	?: Terminal rate constant, calculated as the negative slope of the ln-linear portion of the terminal plasma concentration-time curve (single-dose period only)	Baseline, 2h, 4h, 8h, 12h, 24h, 28h, 32h, 36h and 48h
Secondary	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)	Baseline, 2h, 4h, 8h, 12h, 24h, 28h, 32h, 36h and 48h