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Sponsored by: |
Boehringer Ingelheim Pharmaceuticals |
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Information provided by: | Boehringer Ingelheim Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00239395 |
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.
Condition | Intervention | Phase |
---|---|---|
Osteoarthritis |
Drug: Meloxicam ampoule Drug: Meloxicam tablet |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | 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) |
Estimated Enrollment: | 150 |
Study Start Date: | July 2004 |
Estimated Study Completion Date: | December 2004 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
The diagnosis must be based on
x-ray diagnosis plus clinical signs and symptoms
Exclusion Criteria:
China | |
Shanghai Renji Hospital | |
Shanghai, China, 200001 | |
Shanghai Zhongshan Hospital | |
Shanghai, China, 200032 | |
Shanghai Changhai Hospital | |
Shanghai, China, 200443 | |
Shanghai Guanghai Hospital | |
Shanghai, China, 200052 | |
1st Affiliated, Anhui Medical University | |
Hefei City, Anhui Province, China, 230022 | |
Beijing Xuan Wu Hospital | |
Beijing, China, 100050 | |
Qilu Hospital, Shang Dong University | |
Nan City, China, 250012 | |
People's Hospital, Beijing University | |
Beijing, China, 100044 |
Study Chair: | Boehringer Ingelheim Study Coordinator | Boehringer Ingelheim Shanghai |
Study ID Numbers: | 107.265 |
Study First Received: | October 13, 2005 |
Last Updated: | August 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00239395 |
Health Authority: | China: State Food and Drug Administration |
Musculoskeletal Diseases Osteoarthritis Joint Diseases |
Arthritis Meloxicam Rheumatic Diseases |
Anti-Inflammatory Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Cyclooxygenase Inhibitors Enzyme Inhibitors Pharmacologic Actions Analgesics, Non-Narcotic |
Sensory System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents |