Trial Outcomes & Findings for A Pilot Study of Switching From One Pain Medication to Another (Opioid Rotation) (NCT NCT00580294)

Results Overview

PGIC score - participants answered 2 questions regarding change in overall status and overall activity from baseline using a 7-point scale (1 = Very Much Improved, 2 = Much Improved, 3 = Minimally Improved, 4 = No Change, 5 = Minimally Worse, 6 = Much Worse, 7 = Very Much Worse)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

12 participants

Primary outcome timeframe

baseline and 12 hours

Results posted on

2016-02-03

Participant Flow

study conducted at Mount Sinai School of Medicine, Department of Anesthesiology, Clinical Research Center (CRC), New York, NY, and enrolled patients from August 10, 2007 to August 9, 2008

Participant milestones

Participant milestones
Measure	Oxymorphone participants switched to oxymorphone extended release (ER) via both oral and intravenous patient-controlled analgesia (IV-PCA) oxymorphone. After 24 hours, participants were discharged with oral oxymorphone ER and oxymorphone immediate release (IR) as needed
Overall Study STARTED	12
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Pilot Study of Switching From One Pain Medication to Another (Opioid Rotation)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Oxymorphone n=12 Participants oral oxymorphone ER as the basal opioid during the first 24 hours and supplemental IV-PCA oxymorphone as needed during period 1. During period 2, participants underwent a 2-week oral titration. The oxymorphone ER and IR dosages were adjusted up or down as needed to maintain pain control.
Age, Continuous	50.4 years STANDARD_DEVIATION 12.4 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Average Pain Intensity	7.34 units on a scale STANDARD_DEVIATION 1.18 • n=5 Participants

PRIMARY outcome

Timeframe: baseline and 12 hours

PGIC score - participants answered 2 questions regarding change in overall status and overall activity from baseline using a 7-point scale (1 = Very Much Improved, 2 = Much Improved, 3 = Minimally Improved, 4 = No Change, 5 = Minimally Worse, 6 = Much Worse, 7 = Very Much Worse)

Outcome measures

Outcome measures
Measure	Oxymorphone n=12 Participants oral oxymorphone ER as the basal opioid during the first 24 hours and supplemental IV-PCA oxymorphone as needed during period 1. During period 2, participants underwent a 2-week oral titration. The oxymorphone ER and IR dosages were adjusted up or down as needed to maintain pain control.
Change in Patient Global Impression of Change	0.19 units on a scale Interval 0.08 to 0.44

PRIMARY outcome

Timeframe: Assessed daily for 10 days prior to IV PCA treatment, and assessed daily for 2 weeks after IV PCA treatment

Outcome measures

Outcome data not reported

Adverse Events

Oxymorphone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Marco Pappagallo, MD

Icahn School of Medicine at Mount Sinai

Phone: 212-241-7749

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place