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| Tracking Information | |
|---|---|
| First Received Date ICMJE | September 13, 2005 |
| Last Updated Date | May 29, 2006 |
| Start Date ICMJE | |
| Primary Completion Date | |
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current |
| Change History | Complete list of historical versions of study NCT00171678 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE |
|
| Original Secondary Outcome Measures ICMJE | Same as current |
| Descriptive Information | |
| Brief Title ICMJE | Efficacy and Safety of Diclofenac Sodium Gel in Knee Osteoarthritis |
| Official Title ICMJE | Efficacy and Safety of Diclofenac Sodium Gel in Knee Osteoarthritis |
| Brief Summary | This study will test the efficacy and safety of topical diclofenac sodium gel in the treatment of knee osteoarthritis. |
| Detailed Description | |
| Study Phase | Phase III |
| Study Type ICMJE | Interventional |
| Study Design ICMJE | Allocation: Randomized Control: Placebo Control Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Condition ICMJE | Osteearthritis |
| Intervention ICMJE | Drug: Diclofenac Topical Sodium Gel 1% |
| Study Arms / Comparison Groups | |
| Publications * | |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Enrollment ICMJE | 480 |
| Completion Date | |
| Primary Completion Date | |
| Eligibility Criteria ICMJE | Key Inclusion criteria
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| Gender | Both |
| Ages | 35 Years and older |
| Accepts Healthy Volunteers | No |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | United States |
| Administrative Information | |
| NCT ID ICMJE | NCT00171678 |
| Responsible Party | |
| Study ID Numbers ICMJE | VOSG-PN-310 |
| Study Sponsor ICMJE | Novartis |
| Collaborators ICMJE | |
| Investigators ICMJE | |
| Information Provided By | Novartis |
| Verification Date | May 2006 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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