A Study to Compare Meloxicam IM Once Daily and Meloxicam Administered Orally Once Daily in Patients With Osteoarthritis

Boehringer Ingelheim

Status and phase

Completed

Phase 3

Conditions

Osteoarthritis

Treatments

Drug: Meloxicam ampoule

Drug: Meloxicam tablet

Study type

Interventional

Funder types

Industry

Identifiers

NCT00239395

107.265

Details and patient eligibility

About

The objective of this trial was to assess the efficacy and safety of 7.5 mg meloxicam i.m. once daily compared with 7.5 mg meloxicam tablets once daily p.o. in patients with osteoarthritis over a time period of 7 days.

Full description

This was a randomized (1:1), open-label, multi-center, active-control, parallel-group study to compare the efficacy of 7.5 mg meloxicam i.m. once daily compared with 7.5 mg meloxicam tablets once daily p.o. in patients with osteoarthritis over a time period of 7 days.

The primary endpoint: Pain on active movement,

The secondary endpoint:

Pain at rest
Patient status with regard to change of arthritic condition assessed by the patient/investigator
Patient's assessment of arthritic condition
Onset of action
Time to maximum pain relief
Paracetamol consumption
Withdrawals due to inadequate efficacy
Final global assessment of efficacy by the patient/investigator

Safety endpoints

Local tolerability assessment of the injections by the patient/investigator
Patient's /Investigator's assessment of overall tolerability
Number, nature and severity of adverse events
Laboratory investigations
Withdrawals due to safety reasons

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 Hypothesis:

The null hypothesis of interest is that the primary endpoint for meloxicam ampoule is inferior to oral meloxicam. The alternative is that meloxicam ampoule is noninferior to the oral meloxicam .

Comparison(s):

The primary endpoint of the study was to assess pain on active movement by VAS prior and after the treatment.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male or female aged 18 years or above
Patients suffering from acute and painful exacerbation of osteoarthritis of the hip or knee.

The diagnosis must be based on

clinical signs and symptoms or
x-ray diagnosis plus clinical signs and symptoms
- Assessment of pain on active movement (by the patient) must exceed 40 mm on a 100 mm visual analogue scale (VAS)
- Symptoms of OA requiring administration of NSAIDs
- 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 last six 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 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
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 transferase (AST/SGOT) and/or alkaline transferase (ALT/SGPT) 200 % of the upper limit of normal range
Platelet count < 100,000/mm3 ; leucocytes count < 3,000/mm3
Synovectomy in the previous month or during the trial
Participation in another clinical trial during this study or during the previous month
Previous participation in this trial
Patient unable to comply with the protocol
Concomitant therapy with specific symptomatic drug of OA, such as chondroitin sulphate, diacerhein, initiated or with an altered dose over the previous 3 months.
Intraarticular administration of hyaluronic acid in the previous month
Patients where physiotherapy will be changed throughout the study