A Study to Compare Meloxicam IM Once Daily and Meloxicam Administered Orally Once Daily in Patients With Osteoarthritis - Full Text View

Sponsor:	Boehringer Ingelheim Pharmaceuticals
Information provided by:	Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00239395

Purpose

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.

Condition	Intervention	Phase
Osteoarthritis	Drug: Meloxicam ampoule Drug: Meloxicam tablet	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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)

Resource links provided by NLM:

MedlinePlus related topics: Osteoarthritis

Drug Information available for: Meloxicam

U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:

Pain on active movement by VAS.

Secondary Outcome Measures:

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

Estimated Enrollment:	150
Study Start Date:	July 2004
Estimated Study Completion Date:	December 2004

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00239395

Locations

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

Sponsors and Collaborators

Boehringer Ingelheim Pharmaceuticals

Investigators

Study Chair:

Boehringer Ingelheim Study Coordinator

Boehringer Ingelheim Shanghai

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier:	NCT00239395 History of Changes
Other Study ID Numbers:	107.265
Study First Received:	October 13, 2005
Last Updated:	September 24, 2009
Health Authority:	China: State Food and Drug Administration

Additional relevant MeSH terms:

Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Meloxicam
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents

Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 09, 2012