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

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00239382
First received: October 13, 2005
Last updated: May 11, 2012
Last verified: May 2012
  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 3

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.

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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 Guanghai Hospital
Shanghai, China, 200052
Shanghai Renji Hospital
Shanghai, China, 200001
Shanghai Zhongshan Hospital
Shanghai, China, 200032
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Study Coordinator Boehringer Ingelheim Shanghai
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00239382     History of Changes
Other Study ID Numbers: 107.266
Study First Received: October 13, 2005
Last Updated: May 11, 2012
Health Authority: China: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 20, 2014