A Study to Compare Meloxicam IM Once Daily Versus Meloxicam Orally Once Daily in Patients With Rheumatoid Arthritis

NCT ID: NCT00239382

Last Updated: 2018-08-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-07-01
• Study Completion Date: 2004-12-31

Brief Summary

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.

Detailed Description

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.

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.

Conditions

Arthritis, Rheumatoid

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Meloxicam ampoule

Intervention Type: DRUG

Meloxicam tablet

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Boehringer Ingelheim Study Coordinator

Role: STUDY_CHAIR

Boehringer Ingelheim Shanghai

Locations

People's Hospital, Beijing University

Beijing, , China

Beijing Xuan Wu Hospital

Beijing, , China

1st Affiliated, Anhui Medical University

Hefei City, Anhui Province, , China

Qilu Hospital, Shang Dong University

Nanzhou, , China

Shanghai Renji Hospital

Shanghai, , China

Shanghai Zhongshan Hospital

Shanghai, , China

Shanghai Guanghai Hospital

Shanghai, , China

Shanghai Changhai Hospital

Shanghai, , China

Countries

China

Other Identifiers

107.266

Identifier Type: -

Identifier Source: org_study_id