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

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ClinicalTrials.gov Identifier: NCT00414453
Recruitment Status : Terminated (Did not reach enrollment goals)
First Posted : December 21, 2006
Results First Posted : July 17, 2015
Last Update Posted : July 17, 2015
Sponsor:
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
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
Hide 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
Arm/Group Title Lidocaine 5% + Placebo Patch, ER + Placebo Pills
Hide 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
Hide 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
1.Primary Outcome
Title Mean Daily Diary Pain Ratings During Final Week of Each Treatment Period
Hide Description subject identifies daily pain rating during final week of each treatment period using a numeric rating scale
Time Frame Daily
Hide Outcome Measure Data
Hide 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
Hide 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)
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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)
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide Description subject completes the brief pain questionaire
Time Frame occurs Visit 1, 3,4,5
Hide Outcome Measure Data
Hide 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
Hide 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
Hide Description Subject identifies degree of sleep interference on a daily basis
Time Frame daily
Hide Outcome Measure Data
Hide 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
Hide 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
Hide Description Subject completes Beck questionaire
Time Frame occurs at Visit 1, 3, 4 and 5
Hide Outcome Measure Data
Hide 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
Hide 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)
Hide Description Subject completes short form health survey 36 questionaire
Time Frame Occurs at Visit 1, 3, 4 and 5
Hide Outcome Measure Data
Hide 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
Hide 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
Hide Description Subject completes short form McGill Pain questionaire
Time Frame Occurs Visit 1, 3, 4 and 5
Hide Outcome Measure Data
Hide 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
Hide 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
Hide Description Subject completes patient global impression questionaire of change scale
Time Frame Occurs Visit 3, 4, 5
Hide Outcome Measure Data
Hide 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
Hide 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
Hide Description Subject completes questionaire on functional status
Time Frame Occurs at Visit 1
Hide Outcome Measure Data
Hide 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
Hide 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.
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
Hide 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   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide 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 
Show Other (Not Including Serious) Adverse Events Hide 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 
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
Layout table for Results Point of Contact information
Name/Title: Robert H Dworkin
Organization: University of Rochester
Phone: 275-8214
EMail: robert_dworkin@urmc.rochester.edu
Layout table for additonal information
Responsible Party: Robert Dworkin, University of Rochester
ClinicalTrials.gov Identifier: NCT00414453     History of Changes
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