A Study to Compare Meloxicam IM Once Daily and Meloxicam Administered Orally Once Daily in Patients With Osteoarthritis
Information source: Boehringer Ingelheim Pharmaceuticals
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Osteoarthritis
Intervention: Meloxicam ampoule (Drug); Meloxicam tablet (Drug)
Phase: Phase 3
Sponsored by: Boehringer Ingelheim Pharmaceuticals
Official(s) and/or principal investigator(s):
Boehringer Ingelheim Study Coordinator, Study Chair, Affiliation: Boehringer Ingelheim Shanghai
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.
Official title: A Randomised, Open-Labelled Study to Compare the Efficacy and Safety of Meloxicam 7.5 mg IM Ampoules Once Daily and Meloxicam 7.5 mg Tablets Administered Orally Once Daily Over a Period of 7 Days in Patients With Osteoarthritis (OA)
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Pain on active movement by VAS.
Secondary outcome: Pain at rest； Assessment of patient status and arthritic condition; Onset of action; Time to maximum pain relief; Paracetamol consumption; Withdrawals due to inadequate efficacy
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'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
- 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.
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 .
The primary endpoint of the study was to assess pain on active movement by VAS prior and
after the treatment.
Minimum age: 18 Years.
Maximum age: N/A.
- Male or female aged 18 years or above
- Patients suffering from acute and painful exacerbation of osteoarthritis of the hip or
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.
- 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
- 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
- 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
- Previous participation in this trial
- Patient unable to comply with the protocol
- Concomitant therapy with specific symptomatic drug of OA, such as chondroitine
sulphate, diacerheine, 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 troughout the study
Locations and Contacts
Shanghai Renji Hospital, Shanghai 200001, China
Shanghai Zhongshan Hospital, Shanghai 200032, China
Shanghai Changhai Hospital, Shanghai 200443, China
Shanghai Guanghai Hospital, Shanghai 200052, China
People's Hospital, Beijing University, Beijing 100044, China
Beijing Xuan Wu Hospital, Beijing 100050, China
Qilu Hospital, Shang Dong University, Nan City 250012, China
1st Affiliated, Anhui Medical University, Hefei City, Anhui Province 230022, China
Starting date: July 2004
Ending date: December 2004
Last updated: April 4, 2008