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.”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

This was a randomized (1:1), open-label, multi-center, active-control, parallel-group study to compare the efficacy 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.

The primary endpoint: - Patient's assessment of overall pain - Patient's global assessment of disease activity

The secondary endpoint: - Tender/swollen joint count - Investigator's global assessment of disease activity - Patient's assessment of physical function - Duration of morning stiffness - Patient status with regard to change of arthritic condition assessed by the patient/investigator - Onset of action - Time to maximum pain relief - Paracetamol consumption - Withdrawals due to inadequate efficacy - Final global assessment of efficacy by the patient/inveatigator

Safety endpoints - Local tolerability assessment of the injections by the patient/investigator - Patient's /Investigator's assessment of overall tolerability - Number, nature and severity of adverse events - Laboratory investigations - Withdrawals due to safety reasons

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.

The primary endpoint: Pain on active movement,

The secondary endpoint: - Pain at rest - Patient status with regard to change of arthritic condition assessed by the patient/investigator - Patient's assessment of arthritic condition - Onset of action - Time to maximum pain relief - Paracetamol consumption - Withdrawals due to inadequate efficacy - Final global assessment of efficacy by the patient/investigator

Safety endpoints - Local tolerability assessment of the injections by the patient/investigator - Patient's /Investigator's assessment of overall tolerability - Number, nature and severity of adverse events - Laboratory investigations - Withdrawals due to safety reasons

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): - Patient's assessment of overall pain by VAS prior and after the treatment - Patient's global assessment of disease activity by VAS prior and after the treatment

Intervention(s) in this Clinical Trial

• Drug: Meloxicam ampoule
• Drug: Meloxicam tablet

Primary Measures

• Patient's assessment of overall pain
• Patient's global assessment of disease activity

Secondary Measures

• Tender/swollen joint count; Global assessment of disease activity; Assessment of physical function and patient status; Duration of morning stiffness.

Inclusion Criteria:

• Male or female aged 18 years or above
• The patient has rheumatoid arthritis, as defined by the American Rheumatism
• Association.
• Assessment of overall pain (by the patient), after a washout for NSAID of at least 2 days (3 days for oxicams), must exceed 40 mm on a 100 mm visual analogue scale (VAS)
• Symptoms of RA requiring administration of NSAIDs
• Outpatients
• Willingness and ability to provide written informed consent.

Exclusion Criteria:

• Known or suspected hypersensitivity to the trial drugs or their excipients, analgesics, antipyretics or NSAIDs
• Any clinical evidence of active peptic ulceration during the previous 6 months
• Pregnancy or breastfeeding (precaution: attention should be drawn to reports that
• NSAIDs were reported to decrease the effectivity of intrauterine devices)
• Asthma, nasal polyps, angioneurotic oedema or urticaria following the administration of aspirin or NSAIDs
• Concomitant treatment with anti-coagulants (including heparin), lithium
• Concomitant administration of other NSAIDs or analgesic agents (except paracetamol up to 4g/day)
• Administration of any NSAID during the last 2 days (3 days for any oxicam) prior to the first administration of the trial drug
• Concomitant treatment with methotrexate, sulfasalazine, D-penicillamine, chloroquine or any other disease modifying antirheumatic drug initiated or with an altered dose over the previous 3 months
• Concomitant treatment with an oral corticosteroid initiated or with an altered dose over the previous month
• Parenteral or intraarticular administration of corticosteroids in the previous month
• Any i.m. injection during the previous 7 days
• Synovectomy and/or surgical treatment for RA in the previous month or during the trial
• Any physiotherapy which will be changed during the trial
• Any contra-indication to i.m. injections
• Clinical evidence of or known severe cardiac, hepatic, renal, metabolic, haematological disease, mental disturbance, ulcerative colitis
• Any other rheumatological or non-rheumatological disease that could interfere with the evaluation of efficacy and safety
• Serum creatinine 125 % of the upper limit of normal range ; aspartate amino-transferase (AST/SGOT) and/or alaline amino-transferase (ALT/SGPT) 200 % of the upper limit of normal range
• Platelet count < 100,000/mm3 ; leucocytes count < 3,000/mm3
• Participation in another clinical trial during this study or during the previous month
• Previous participation in this trial (i.e. having been allocated a randomized treatment number)
• Patient unable to comply with the protocol

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Boehringer Ingelheim Pharmaceuticals

Overall Clinical Trial Officials and Contacts

Boehringer Ingelheim Study Coordinator Study Chair Boehringer Ingelheim Shanghai  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00239382

Study ID Number: 107.266

ClinicalTrials.gov Identifier: NCT00239382

Health Authority: China: State Food and Drug Administration