Trial Outcomes & Findings for Trial of Analgesia With Lidocaine or Extended-release Oxycodone for Neuropathic Pain Treatment in Multiple Sclerosis (NCT NCT00414453)

Results Overview

subject identifies daily pain rating during final week of each treatment period using a numeric rating scale

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

19 participants

Primary outcome timeframe

Daily

Results posted on

2015-07-17

Participant Flow

7-6-2006 to 9-23-2008 at the medical center

19 subjects were enrolled in this study however the study was terminated due to not reaching enrollment goals in a timely manner. Therefore there was no data analysis completed for this study. We do not have randomization data for these participants because the data is not available and is locked.

Participant milestones

Participant milestones
Measure	Lidocaine 5% + Placebo Patch, ER + Placebo Pills 5% lidocaine patch used as intervention Lidocaine patch 5%: lidocaine 5% patch; 12 hours on, 12 hours off placebo patch used with extended release oxycodone or with placebo pills and placebo patches arm Placebo lidocaine patches: used with extended release oxycodone group; used with placebo prandomized subjects given extended release oxycodone and placebo patches during this treatment period Extended-release oxycodone: extended-release oxycodone titrating scheduleills/placebo patches placebo pills used with lidocaine 5% patch group and with placebo patch/placebo pill group Placebo extended-release oxycodone pills: placebo pills with titrating schedule
Overall Study STARTED	19
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	16

Reasons for withdrawal

Reasons for withdrawal
Measure	Lidocaine 5% + Placebo Patch, ER + Placebo Pills 5% lidocaine patch used as intervention Lidocaine patch 5%: lidocaine 5% patch; 12 hours on, 12 hours off placebo patch used with extended release oxycodone or with placebo pills and placebo patches arm Placebo lidocaine patches: used with extended release oxycodone group; used with placebo prandomized subjects given extended release oxycodone and placebo patches during this treatment period Extended-release oxycodone: extended-release oxycodone titrating scheduleills/placebo patches placebo pills used with lidocaine 5% patch group and with placebo patch/placebo pill group Placebo extended-release oxycodone pills: placebo pills with titrating schedule
Overall Study Abnormal lab work	16

Baseline Characteristics

Trial of Analgesia With Lidocaine or Extended-release Oxycodone for Neuropathic Pain Treatment in Multiple Sclerosis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lidocaine 5% + Placebo Patch, ER + Placebo Pills n=19 Participants 5% lidocaine patch used as intervention Lidocaine patch 5%: lidocaine 5% patch; 12 hours on, 12 hours off placebo patch used with extended release oxycodone or with placebo pills and placebo patches arm Placebo lidocaine patches: used with extended release oxycodone group; used with placebo prandomized subjects given extended release oxycodone and placebo patches during this treatment period Extended-release oxycodone: extended-release oxycodone titrating scheduleills/placebo patches placebo pills used with lidocaine 5% patch group and with placebo patch/placebo pill group Placebo extended-release oxycodone pills: placebo pills with titrating schedule
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	18 Participants n=93 Participants
Age, Categorical >=65 years	1 Participants n=93 Participants
Sex: Female, Male Female	16 Participants n=93 Participants
Sex: Female, Male Male	3 Participants n=93 Participants
Region of Enrollment United States	19 participants n=93 Participants

PRIMARY outcome

Timeframe: Daily

Population: Data was not analyzed because we the data is locked and is not available.

subject identifies daily pain rating during final week of each treatment period using a numeric rating scale

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: rating of adverse events occur at each visit

Population: Data was not analyzed because we did not reach our enrollment goal and the study was terminated. Data was not analyzed because we the data is locked and is not available.

subject is questioned regarding any adverse events that have occured since the last contact; also subject can document any issues on daily pain rating diaries

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: rating and review of any adverse events occurs at each visit

Population: Data was not analyzed because we did not reach our enrollment goal and the study was terminated. Data was not analyzed because we the data is locked and is not available.

Subject is asked about any adverse events that may have occurred since last contact; also subject can document any adverse events on daily pain diary scales

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: occurs Visit 1, 3,4,5

Population: Data was not analyzed because we did not reach our enrollment goal and the study was terminated. Data was not analyzed because we the data is locked and is not available.

subject completes the brief pain questionaire

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: daily

Population: Data was not analyzed because we did not reach our enrollment goal and the study was terminated.. Data was not analyzed because we the data is locked and is not available.

Subject identifies degree of sleep interference on a daily basis

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: occurs at Visit 1, 3, 4 and 5

Population: Data was not analyzed because we did not reach our enrollment goal and the study was terminated. Data was not analyzed because we the data is locked and is not available.

Subject completes Beck questionaire

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Occurs at Visit 1, 3, 4 and 5

Population: Data was not analyzed because we did not reach our enrollment goal and the study was terminated. Data was not analyzed because we the data is locked and is not available.

Subject completes short form health survey 36 questionaire

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Occurs Visit 1, 3, 4 and 5

Population: Data was not analyzed because we did not reach our enrollment goal and the study was terminated. Data was not analyzed because we the data is locked and is not available.

Subject completes short form McGill Pain questionaire

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Occurs Visit 3, 4, 5

Population: Data was not analyzed because we did not reach our enrollment goal and the study was terminated. Data was not analyzed because we the data is locked and is not available.

Subject completes patient global impression questionaire of change scale

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Occurs at Visit 1

Population: Data was not analyzed because we did not reach our enrollment goal and the study was terminated. Data was not analyzed because we the data is locked and is not available.

Subject completes questionaire on functional status

Outcome measures

Outcome data not reported

Adverse Events

Lidocaine Patch 5%

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo Patch

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Extended Release Oxycodone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo Pills

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

Robert H Dworkin

University of Rochester

Phone: 275-8214

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place