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

Condition(s) targeted: Osteoarthritis

Intervention: Meloxicam ampoule (Drug); Meloxicam tablet (Drug)

Phase: Phase 3

Status: Completed

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

Detailed 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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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 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

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