Trial record 1 of 1 for:
NCT00589979
Efficacy and Safety of the Lidoderm Patch Applied to Patients With Osteoarthritis of the Knee
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00589979 |
Recruitment Status :
Completed
First Posted : January 10, 2008
Results First Posted : September 22, 2010
Last Update Posted : October 5, 2017
|
Sponsor:
Endo Pharmaceuticals
Information provided by (Responsible Party):
Endo Pharmaceuticals
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Study Type | Interventional |
---|---|
Study Design | Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment |
Condition |
Osteoarthritis of the Knee |
Interventions |
Drug: Lidoderm (Lidocaine 5% Patch) Drug: Placebo Patch |
Enrollment | 169 |
Participant Flow
Recruitment Details | This exploratory, Phase IIb study was initiated on March 6, 2007 at 21 study centers in the United States and completed on June 24, 2008. |
Pre-assignment Details | During the active Run-in Period, eligible patients applied Lidoderm patches every 24 hours for 28 days. During the 12-week Double-blind Treatment Period, patients were randomized to apply Lidoderm patches or matching placebo patches every 24 hours for 4 weeks and then crossed over to the other treatment for the next two 4-week treatment periods. |
Arm/Group Title | Run-in Period: Lidoderm | Treatment Sequence: Lidoderm - Placebo - Placebo | Treatment Sequence: Placebo - Lidoderm - Lidoderm |
---|---|---|---|
![]() |
Run-in Period with patients applying Lidoderm (lidocaine 5% patch) 10cm x 14cm each on the front and back of the index knee every 24 hours for up to 28 days (4 weeks). | Lidoderm (lidocaine 5% patch) 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h) for up to 4 weeks followed by matching placebo 10cm x 14cm patches each on the front and back of the index knee q24h for up to 8 weeks | Matching placebo 10cm X 14cm patches each on the front and back of the index knee q24h for up to 4 weeks followed by Lidoderm (lidocaine 5% patch) 10cm x 14cm patches each on the front and back of the index knee q24h for up to 8 weeks |
Period Title: Run-In Period | |||
Started | 169 | 0 | 0 |
Completed | 93 | 0 | 0 |
Not Completed | 76 | 0 | 0 |
Reason Not Completed | |||
Adverse Event | 5 | 0 | 0 |
Protocol Violation | 3 | 0 | 0 |
Did not qualify for randomization | 54 | 0 | 0 |
Withdrawal by Subject | 10 | 0 | 0 |
Informed Consent Withdrawn | 4 | 0 | 0 |
Period Title: Double-Blind Treatment Period 1 | |||
Started | 0 [1] | 50 [2] | 43 [2] |
Completed | 0 | 48 | 41 |
Not Completed | 0 | 2 | 2 |
Reason Not Completed | |||
Adverse Event | 0 | 1 | 0 |
Protocol Violation | 0 | 1 | 1 |
Withdrawal by Subject | 0 | 0 | 1 |
[1]
Participants completing the Run-in Period were then randomized to two different treatment sequences.
[2]
N=21 randomized on or after 22JAN2008; included in mod. intent-to-treat (MITT) analysis population.
|
|||
Period Title: Double-Blind Treatment Period 2 | |||
Started | 0 | 48 [1] | 41 [2] |
Completed | 0 | 47 | 39 |
Not Completed | 0 | 1 | 2 |
Reason Not Completed | |||
Adverse Event | 0 | 1 | 0 |
Withdrawal by Subject | 0 | 0 | 1 |
Other | 0 | 0 | 1 |
[1]
N=19 randomized on or after 22JAN2008; included in mod. intent-to-treat (MITT) analysis population.
[2]
N=20 randomized on or after 22JAN2008; included in mod. intent-to-treat (MITT) analysis population.
|
|||
Period Title: Double-Blind Treatment Period 3 | |||
Started | 0 | 47 [1] | 39 [1] |
Completed | 0 | 46 | 38 |
Not Completed | 0 | 1 | 1 |
Reason Not Completed | |||
Protocol Violation | 0 | 1 | 0 |
Withdrawal by Subject | 0 | 0 | 1 |
[1]
N=19 randomized on or after 22JAN2008; included in mod. intent-to-treat (MITT) analysis population.
|
Baseline Characteristics
Arm/Group Title | Sequence: Lidoderm - Placebo - Placebo | Sequence: Placebo - Lidoderm - Lidoderm | Total | |
---|---|---|---|---|
![]() |
Lidoderm (lidocaine 5% patch) 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h) for 4 weeks followed by matching placebo 10cm x 14cm patches each on the front and back of the index knee q24h for up to 8 weeks. | Matching placebo 10cm X 14cm patches each on the front and back of the index knee q24h for 4 weeks followed by Lidoderm (lidocaine 5% patch) 10cm x 14cm patches each on the front and back of the index knee q24h for up to 8 weeks. | Total of all reporting groups | |
Overall Number of Baseline Participants | 50 | 43 | 93 | |
![]() |
[Not Specified]
|
|||
Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
||||
Number Analyzed | 50 participants | 43 participants | 93 participants | |
61.1 (10.0) | 61.1 (10.9) | 61.1 (10.4) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
||||
Number Analyzed | 50 participants | 43 participants | 93 participants | |
Female |
32 64.0%
|
28 65.1%
|
60 64.5%
|
|
Male |
18 36.0%
|
15 34.9%
|
33 35.5%
|
|
Region of Enrollment
Measure Type: Number Unit of measure: Participants |
||||
United States | Number Analyzed | 50 participants | 43 participants | 93 participants |
50 | 43 | 93 |
Outcome Measures
Adverse Events
Limitations and Caveats
Due to operational issues, the modified intent-to-treat (MITT) population, consisting of all intent-to-treat (ITT) patients randomized on or after January 22, 2008, was added to the analysis plan; all efficacy data are presented for this population.
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
Delay of 12-18 months from Completion Date to publish results from all sites, embargo of 60 to 180 days from the time communication is submitted to sponsor, and ability to redact confidential information (excluding results).
Results Point of Contact
Name/Title: | Clinical Trial Coordinator |
Organization: | Endo Pharmaceuticals, Inc. |
Phone: | Use e-mail contact |
EMail: | clinicalsite.inquiries@endo.com |
Responsible Party: | Endo Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00589979 |
Other Study ID Numbers: |
EN3260-003 |
First Submitted: | December 26, 2007 |
First Posted: | January 10, 2008 |
Results First Submitted: | December 22, 2009 |
Results First Posted: | September 22, 2010 |
Last Update Posted: | October 5, 2017 |