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A Study to Compare Meloxicam IM Once Daily Versus Meloxicam Orally Once Daily in Patients With Rheumatoid Arthritis
This study has been completed.
First Received: October 13, 2005   Last Updated: September 24, 2009   History of Changes
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: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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.

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:
  • Patient's assessment of overall pain
  • Patient's global assessment of disease activity

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

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
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00239382

Locations
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
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
Study Chair: Boehringer Ingelheim Study Coordinator Boehringer Ingelheim Shanghai
  More Information

Additional Information:
No publications provided

Study ID Numbers: 107.266
Study First Received: October 13, 2005
Last Updated: September 24, 2009
ClinicalTrials.gov Identifier: NCT00239382     History of Changes
Health Authority: China: State Food and Drug Administration

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Autoimmune Diseases
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Joint Diseases
Cyclooxygenase Inhibitors
Physiological Effects of Drugs
Meloxicam
Arthritis, Rheumatoid
Enzyme Inhibitors
Rheumatic Diseases
Pharmacologic Actions
Musculoskeletal Diseases
Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Arthritis
Connective Tissue Diseases
Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010