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

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 Overview

• Status: Completed
• Conditions: Arthritis, Rheumatoid
• Intervention / Treatment: Drug: Meloxicam ampoule; Drug: Meloxicam tablet

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.

• Study Type: Interventional
• Enrollment: 150
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100044
    • People's Hospital, Beijing University
  • Beijing, China, 100050
    • Beijing Xuan Wu Hospital
  • Hefei City, Anhui Province, China, 230022
    • 1st Affiliated, Anhui Medical University
  • Nan City, China, 250012
    • Qilu Hospital, Shang Dong University
  • Shanghai, China, 200032
    • Shanghai Zhongshan Hospital
  • Shanghai, China, 200001
    • Shanghai Renji Hospital
  • Shanghai, China, 200052
    • Shanghai Guanghai Hospital
  • Shanghai, China, 200443
    • Shanghai Changhai Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Patient's assessment of overall pain	7 days
Patient's global assessment of disease activity	7 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Investigator's Global Assessment of Disease Activity	7 days
Tender/Painful Joint Count	7 days
Swollen Joint Count	7 days
Duration of Morning Stiffness	7 days
Patient's assessment of physical function	7 days
Final Global Assessment of Efficacy by Patient	7 days
Final Global Assessment of Efficacy by Investigator	7 days
Withdrawals due to Inadequate Efficacy	7 days
Change in Patient Status With Regard to Arthritic Condition as Assessed by the Patient	7 days
Change in Patient Status With Regard to Arthritic Condition as Assessed by the Investigator	7 days
Onset of Analgesic Action	7 days
Time to Maximum Pain Relief After the First Trial Drug Administration	7 days
Paracetamol Consumption	7 days

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim
• Investigators: Study Chair: Boehringer Ingelheim Study Coordinator, Boehringer Ingelheim Shanghai

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2004
• Primary Completion (Actual): December 1, 2004
• Study Completion (Actual): December 31, 2004

Study Registration Dates

• First Submitted: October 13, 2005
• First Submitted That Met QC Criteria: October 13, 2005
• First Posted (Estimate): October 17, 2005

Study Record Updates

• Last Update Posted (Actual): August 3, 2018
• Last Update Submitted That Met QC Criteria: August 1, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Cyclooxygenase 2 Inhibitors; Meloxicam
• Other Study ID Numbers: 107.266