Clinical trial NCT00239382: A Study to Compare Meloxicam IM Once Daily Versus Meloxicam Orally Once Daily in Patients With Rheumatoid Arthritis
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Arthritis, Rheumatoid
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2005-10-17
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Patient's assessment of overall pain
timeFrame: 7 days
measure: Patient's global assessment of disease activity
timeFrame: 7 days
Secondary outcomes:
measure: Investigator's Global Assessment of Disease Activity
timeFrame: 7 days
measure: Tender/Painful Joint Count
timeFrame: 7 days
measure: Swollen Joint Count
timeFrame: 7 days
measure: Duration of Morning Stiffness
timeFrame: 7 days
measure: Patient's assessment of physical function
timeFrame: 7 days
measure: Final Global Assessment of Efficacy by Patient
timeFrame: 7 days
measure: Final Global Assessment of Efficacy by Investigator
timeFrame: 7 days
measure: Withdrawals due to Inadequate Efficacy
timeFrame: 7 days
measure: Change in Patient Status With Regard to Arthritic Condition as Assessed by the Patient
timeFrame: 7 days
measure: Change in Patient Status With Regard to Arthritic Condition as Assessed by the Investigator
timeFrame: 7 days
measure: Onset of Analgesic Action
timeFrame: 7 days
measure: Time to Maximum Pain Relief After the First Trial Drug Administration
timeFrame: 7 days
measure: Paracetamol Consumption
timeFrame: 7 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: People's Hospital, Beijing University
city: Beijing
country: China
facility: Beijing Xuan Wu Hospital
city: Hefei City, Anhui Province
country: China
facility: 1st Affiliated, Anhui Medical University
city: Nan City
country: China
facility: Qilu Hospital, Shang Dong University
city: Shanghai
country: China
facility: Shanghai Renji Hospital
city: Shanghai
country: China
facility: Shanghai Zhongshan Hospital
city: Shanghai
country: China
facility: Shanghai Guanghai Hospital
city: Shanghai
country: China
facility: Shanghai Changhai Hospital
Study officials:
affiliation: Boehringer Ingelheim Shanghai
name: Boehringer Ingelheim Study Coordinator
role: STUDY_CHAIR
References: