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Tracking Information | |||||
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First Received Date ICMJE | October 13, 2005 | ||||
Last Updated Date | May 11, 2012 | ||||
Start Date ICMJE | July 2004 | ||||
Primary Completion Date | |||||
Current Primary Outcome Measures ICMJE |
Pain on active movement by VAS. | ||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | Complete list of historical versions of study NCT00239395 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
Pain at rest; Assessment of patient status and arthritic condition; Onset of action; Time to maximum pain relief; Paracetamol consumption; Withdrawals due to inadequate efficacy | ||||
Original Secondary Outcome Measures ICMJE |
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Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | A Study to Compare Meloxicam IM Once Daily and Meloxicam Administered Orally Once Daily in Patients With Osteoarthritis | ||||
Official Title ICMJE | A Randomised, Open-labelled Study to Compare the Efficacy and Safety of Meloxicam 7.5 mg IM Ampoules Once Daily and Meloxicam 7.5 mg Tablets Administered Orally Once Daily Over a Period of 7 Days in Patients With Osteoarthritis (OA) | ||||
Brief Summary | The objective of this trial was to assess the efficacy and safety of 7.5 mg meloxicam i.m. once daily compared with 7.5 mg meloxicam tablets once daily p.o. in patients with osteoarthritis over a time period of 7 days. |
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Detailed Description | This was a randomized (1:1), open-label, multi-center, active-control, parallel-group study to compare the efficacy of 7.5 mg meloxicam i.m. once daily compared with 7.5 mg meloxicam tablets once daily p.o. in patients with osteoarthritis over a time period of 7 days. The primary endpoint: Pain on active movement, The secondary endpoint:
Safety endpoints
Patients eligible for the trial who met all inclusion and exclusion criteria and who gave their informed consent were randomized to one of two treatment groups (i.e. meloxicam ampoule or meloxicam tablet). The study period totaled 8-14 days included screening, randomisation, study drug administration, and 7-day follow-up. The relevant assessment were performed on the day of randomisation and 7-day follow up. Study Hypothesis: The null hypothesis of interest is that the primary endpoint for meloxicam ampoule is inferior to oral meloxicam. The alternative is that meloxicam ampoule is noninferior to the oral meloxicam . Comparison(s): The primary endpoint of the study was to assess pain on active movement by VAS prior and after the treatment. |
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Study Type ICMJE | Interventional | ||||
Study Phase | Phase 3 | ||||
Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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Condition ICMJE | Osteoarthritis | ||||
Intervention ICMJE |
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Study Arms | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Enrollment ICMJE | 150 | ||||
Completion Date | December 2004 | ||||
Primary Completion Date | |||||
Eligibility Criteria ICMJE | Inclusion Criteria:
The diagnosis must be based on
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | China | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00239395 | ||||
Other Study ID Numbers ICMJE | 107.265 | ||||
Has Data Monitoring Committee | |||||
Responsible Party | |||||
Study Sponsor ICMJE | Boehringer Ingelheim Pharmaceuticals | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | Boehringer Ingelheim Pharmaceuticals | ||||
Verification Date | May 2012 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |