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

• ClinicalTrials.gov Identifier: NCT00414453
• Recruitment Status: Terminated
• First Posted: December 21, 2006
• Results First Posted: July 17, 2015
• Last Update Posted: July 17, 2015
• Sponsor: University of Rochester
• Collaborator: Endo Pharmaceuticals
• Information provided by (Responsible Party): Robert Dworkin, University of Rochester

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment
• Conditions: Neuropathic Pain; Chronic Pain; Multiple Sclerosis
• Interventions: Drug: Lidocaine patch 5%; Drug: Extended-release oxycodone; Drug: Placebo extended-release oxycodone pills; Drug: Placebo lidocaine patches
• Enrollment: 19

Participant Flow

Recruitment Details	7-6-2006 to 9-23-2008 at the medical center
Pre-assignment Details	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.

Arm/Group Title	Lidocaine 5% + Placebo Patch, ER + Placebo Pills
Arm/Group Description	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
Period Title: Overall Study
Started	19
Completed	3
Not Completed	16
Reason Not Completed
Abnormal lab work	16

Baseline Characteristics

Arm/Group Title		Lidocaine 5% + Placebo Patch, ER + Placebo Pills
Arm/Group Description		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 Number of Baseline Participants		19
Baseline Analysis Population Description		[Not Specified]
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	19 participants
	<=18 years	0 0.0%
	Between 18 and 65 years	18 94.7%
	>=65 years	1 5.3%
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	19 participants
	Female	16 84.2%
	Male	3 15.8%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
United States	Number Analyzed	19 participants
		19

Outcome Measures

1. Primary Outcome

Title	Mean Daily Diary Pain Ratings During Final Week of Each Treatment Period
Description	subject identifies daily pain rating during final week of each treatment period using a numeric rating scale
Time Frame	Daily

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Lidocaine Patch 5%	Placebo Patch	Extended Release Oxycodone	Placebo Pills
Arm/Group Description:	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 pills/placebo patches	randomized subjects given extended release oxycodone and placebo patches during this treatment period Extended-release oxycodone: extended-release oxycodone titrating schedule	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 Number of Participants Analyzed	0	0	0	0

No data displayed because Outcome Measure has zero total analyzed.

2. Secondary Outcome

Title	Tolerability (e.g., Number of Adverse Effects, Number of Drop-outs)
Description	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
Time Frame	rating of adverse events occur at each visit

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Lidocaine Patch 5%	Placebo Patch	Extended Release Oxycodone	Placebo Pills
Arm/Group Description:	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 pills/placebo patches	randomized subjects given extended release oxycodone and placebo patches during this treatment period Extended-release oxycodone: extended-release oxycodone titrating schedule	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 Number of Participants Analyzed	0	0	0	0

No data displayed because Outcome Measure has zero total analyzed.

3. Secondary Outcome

Title	Safety (i.e., Number of Serious Adverse Events)
Description	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
Time Frame	rating and review of any adverse events occurs at each visit

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Lidocaine Patch 5%	Placebo Patch	Extended Release Oxycodone	Placebo Pills
Arm/Group Description:	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 pills/placebo patches	randomized subjects given extended release oxycodone and placebo patches during this treatment period Extended-release oxycodone: extended-release oxycodone titrating schedule	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 Number of Participants Analyzed	0	0	0	0

No data displayed because Outcome Measure has zero total analyzed.

4. Secondary Outcome

Title	Brief Pain Inventory Interference Items
Description	subject completes the brief pain questionaire
Time Frame	occurs Visit 1, 3,4,5

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Lidocaine Patch 5%	Placebo Patch	Extended Release Oxycodone	Placebo Pills
Arm/Group Description:	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 pills/placebo patches	randomized subjects given extended release oxycodone and placebo patches during this treatment period Extended-release oxycodone: extended-release oxycodone titrating schedule	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 Number of Participants Analyzed	0	0	0	0

No data displayed because Outcome Measure has zero total analyzed.

5. Secondary Outcome

Title	Daily Diary Sleep Interference Ratings
Description	Subject identifies degree of sleep interference on a daily basis
Time Frame	daily

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Lidocaine Patch 5%	Placebo Patch	Extended Release Oxycodone	Placebo Pills
Arm/Group Description:	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 pills/placebo patches	randomized subjects given extended release oxycodone and placebo patches during this treatment period Extended-release oxycodone: extended-release oxycodone titrating schedule	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 Number of Participants Analyzed	0	0	0	0

No data displayed because Outcome Measure has zero total analyzed.

6. Secondary Outcome

Title	Beck Depression Inventory
Description	Subject completes Beck questionaire
Time Frame	occurs at Visit 1, 3, 4 and 5

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Lidocaine Patch 5%	Placebo Patch	Extended Release Oxycodone	Placebo Pills
Arm/Group Description:	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 pills/placebo patches	randomized subjects given extended release oxycodone and placebo patches during this treatment period Extended-release oxycodone: extended-release oxycodone titrating schedule	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 Number of Participants Analyzed	0	0	0	0

No data displayed because Outcome Measure has zero total analyzed.

7. Secondary Outcome

Title	Short-form Health Survey 36 (SF-36)
Description	Subject completes short form health survey 36 questionaire
Time Frame	Occurs at Visit 1, 3, 4 and 5

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Lidocaine Patch 5%	Placebo Patch	Extended Release Oxycodone	Placebo Pills
Arm/Group Description:	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 pills/placebo patches	randomized subjects given extended release oxycodone and placebo patches during this treatment period Extended-release oxycodone: extended-release oxycodone titrating schedule	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 Number of Participants Analyzed	0	0	0	0

No data displayed because Outcome Measure has zero total analyzed.

8. Secondary Outcome

Title	Short-Form McGill Pain Questionnaire
Description	Subject completes short form McGill Pain questionaire
Time Frame	Occurs Visit 1, 3, 4 and 5

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Lidocaine Patch 5%	Placebo Patch	Extended Release Oxycodone	Placebo Pills
Arm/Group Description:	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 pills/placebo patches	randomized subjects given extended release oxycodone and placebo patches during this treatment period Extended-release oxycodone: extended-release oxycodone titrating schedule	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 Number of Participants Analyzed	0	0	0	0

No data displayed because Outcome Measure has zero total analyzed.

9. Secondary Outcome

Title	Patient Global Impression of Change Scale
Description	Subject completes patient global impression questionaire of change scale
Time Frame	Occurs Visit 3, 4, 5

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Lidocaine Patch 5%	Placebo Patch	Extended Release Oxycodone	Placebo Pills
Arm/Group Description:	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 pills/placebo patches	randomized subjects given extended release oxycodone and placebo patches during this treatment period Extended-release oxycodone: extended-release oxycodone titrating schedule	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 Number of Participants Analyzed	0	0	0	0

No data displayed because Outcome Measure has zero total analyzed.

10. Secondary Outcome

Title	Kurtzke Expanded Disability Status Scale
Description	Subject completes questionaire on functional status
Time Frame	Occurs at Visit 1

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Lidocaine Patch 5%	Placebo Patch	Extended Release Oxycodone	Placebo Pills
Arm/Group Description:	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 pills/placebo patches	randomized subjects given extended release oxycodone and placebo patches during this treatment period Extended-release oxycodone: extended-release oxycodone titrating schedule	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 Number of Participants Analyzed	0	0	0	0

No data displayed because Outcome Measure has zero total analyzed.

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	Adverse events were not collected.
Arm/Group Title	Lidocaine Patch 5%	Placebo Patch	Extended Release Oxycodone	Placebo Pills
Arm/Group Description	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 pills/placebo patches	randomized subjects given extended release oxycodone and placebo patches during this treatment period Extended-release oxycodone: extended-release oxycodone titrating schedule	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
All-Cause Mortality
	Lidocaine Patch 5%	Placebo Patch	Extended Release Oxycodone	Placebo Pills
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	--/--	--/--	--/--	--/--
Serious Adverse Events
	Lidocaine Patch 5%	Placebo Patch	Extended Release Oxycodone	Placebo Pills
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/0	0/0	0/0	0/0
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Lidocaine Patch 5%	Placebo Patch	Extended Release Oxycodone	Placebo Pills
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/0	0/0	0/0	0/0

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: Robert H Dworkin
• Organization: University of Rochester
• Phone: 275-8214
• EMail: robert_dworkin@urmc.rochester.edu

• Responsible Party: Robert Dworkin, University of Rochester
• ClinicalTrials.gov Identifier: NCT00414453
• Other Study ID Numbers: TALENT-MS
• First Submitted: December 19, 2006
• First Posted: December 21, 2006
• Results First Submitted: March 11, 2015
• Results First Posted: July 17, 2015
• Last Update Posted: July 17, 2015