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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00239382
Recruitment Status : Completed
First Posted : October 17, 2005
Last Update Posted : August 3, 2018
Information provided by (Responsible Party):
Boehringer Ingelheim

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.

Condition or disease Intervention/treatment Phase
Arthritis, Rheumatoid Drug: Meloxicam ampoule Drug: Meloxicam tablet Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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.
Actual Study Start Date : July 1, 2004
Actual Primary Completion Date : December 1, 2004
Actual Study Completion Date : December 31, 2004

Resource links provided by the National Library of Medicine

Drug Information available for: Meloxicam

Primary Outcome Measures :
  1. Patient's assessment of overall pain [ Time Frame: 7 days ]
  2. Patient's global assessment of disease activity [ Time Frame: 7 days ]

Secondary Outcome Measures :
  1. Investigator's Global Assessment of Disease Activity [ Time Frame: 7 days ]
  2. Tender/Painful Joint Count [ Time Frame: 7 days ]
  3. Swollen Joint Count [ Time Frame: 7 days ]
  4. Duration of Morning Stiffness [ Time Frame: 7 days ]
  5. Patient's assessment of physical function [ Time Frame: 7 days ]
  6. Final Global Assessment of Efficacy by Patient [ Time Frame: 7 days ]
  7. Final Global Assessment of Efficacy by Investigator [ Time Frame: 7 days ]
  8. Withdrawals due to Inadequate Efficacy [ Time Frame: 7 days ]
  9. Change in Patient Status With Regard to Arthritic Condition as Assessed by the Patient [ Time Frame: 7 days ]
  10. Change in Patient Status With Regard to Arthritic Condition as Assessed by the Investigator [ Time Frame: 7 days ]
  11. Onset of Analgesic Action [ Time Frame: 7 days ]
  12. Time to Maximum Pain Relief After the First Trial Drug Administration [ Time Frame: 7 days ]
  13. Paracetamol Consumption [ Time Frame: 7 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00239382

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People's Hospital, Beijing University
Beijing, China, 100044
Beijing Xuan Wu Hospital
Beijing, China, 100050
1st Affiliated, Anhui Medical University
Hefei City, Anhui Province, China, 230022
Qilu Hospital, Shang Dong University
Nan City, China, 250012
Shanghai Renji Hospital
Shanghai, China, 200001
Shanghai Zhongshan Hospital
Shanghai, China, 200032
Shanghai Guanghai Hospital
Shanghai, China, 200052
Shanghai Changhai Hospital
Shanghai, China, 200443
Sponsors and Collaborators
Boehringer Ingelheim
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Study Chair: Boehringer Ingelheim Study Coordinator Boehringer Ingelheim Shanghai
Additional Information:
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Responsible Party: Boehringer Ingelheim Identifier: NCT00239382    
Other Study ID Numbers: 107.266
First Posted: October 17, 2005    Key Record Dates
Last Update Posted: August 3, 2018
Last Verified: July 2018
Additional relevant MeSH terms:
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Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action