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| Sponsor: | Boehringer Ingelheim Pharmaceuticals |
|---|---|
| Information provided by: | Boehringer Ingelheim Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00239382 |
Purpose
The objective of this trial was to assess the efficacy and safety of 15 mg meloxicam i.m. once daily compared with 15 mg meloxicam tablets once daily p.o. in patients with Rheumatoid arthritis over a time period of 7 days.
| Condition | Intervention | Phase |
|---|---|---|
|
Arthritis, Rheumatoid |
Drug: Meloxicam ampoule Drug: Meloxicam tablet |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Randomized, Open-labelled Study to Compare the Efficacy and Safety of Meloxicam 15 mg IM Ampoules Once Daily and Meloxicam 15 mg Tablets Administered Orally Once Daily Over a Period of 7 Days in Patients With RA. |
| Estimated Enrollment: | 150 |
| Study Start Date: | July 2004 |
| Estimated Study Completion Date: | December 2004 |
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| China | |
| Beijing Xuan Wu Hospital | |
| Beijing, China, 100050 | |
| People's Hospital, Beijing University | |
| Beijing, China, 100044 | |
| 1st Affiliated, Anhui Medical University | |
| Hefei City, Anhui Province, China, 230022 | |
| Qilu Hospital, Shang Dong University | |
| Nan City, China, 250012 | |
| Shanghai Changhai Hospital | |
| Shanghai, China, 200443 | |
| Shanghai Zhongshan Hospital | |
| Shanghai, China, 200032 | |
| Shanghai Renji Hospital | |
| Shanghai, China, 200001 | |
| Shanghai Guanghai Hospital | |
| Shanghai, China, 200052 | |
| Study Chair: | Boehringer Ingelheim Study Coordinator | Boehringer Ingelheim Shanghai |
More Information
| ClinicalTrials.gov Identifier: | NCT00239382 History of Changes |
| Other Study ID Numbers: | 107.266 |
| Study First Received: | October 13, 2005 |
| Last Updated: | September 24, 2009 |
| Health Authority: | China: State Food and Drug Administration |
|
Arthritis Arthritis, Rheumatoid Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Meloxicam Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics |
Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Central Nervous System Agents |