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

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00239395
First received: October 13, 2005
Last updated: October 31, 2013
Last verified: October 2013
  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 3

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:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Pain on active movement by VAS. [ Time Frame: day 0, day 7 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pain at rest [ Time Frame: up to 7 days ] [ Designated as safety issue: No ]
  • Patient status with regard to change of arthritic condition [ Time Frame: up to 7 days ] [ Designated as safety issue: No ]
  • Withdrawals due to inadequate efficacy [ Time Frame: up to 7 days ] [ Designated as safety issue: No ]
  • Onset of Analgesic action [ Time Frame: up to 7 days ] [ Designated as safety issue: No ]
  • Time to maximum pain relief [ Time Frame: up to 7 days ] [ Designated as safety issue: No ]
  • Paracetamol consumption [ Time Frame: up to 7 days ] [ Designated as safety issue: No ]
  • Final global assessment of efficacy by patient [ Time Frame: up to 7 days ] [ Designated as safety issue: No ]
  • Final global assessment of efficacy by investigator [ Time Frame: up to 7 days ] [ Designated as safety issue: No ]
  • Assessment of local tolerability [ Time Frame: up to 7 days ] [ Designated as safety issue: No ]
  • Nature and severity of adverse events [ Time Frame: up to 7 days ] [ Designated as safety issue: No ]
  • Change in other laboratory investigations [ Time Frame: up to 7 days ] [ Designated as safety issue: No ]
  • Withdrawals due to safety reasons [ Time Frame: up to 7 days ] [ Designated as safety issue: No ]
  • Patient's and investigator's assessment of overall tolerability [ Time Frame: up to 7 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 168
Study Start Date: July 2004
Estimated Study Completion Date: December 2004
Primary Completion Date: December 2004 (Final data collection date for primary outcome measure)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Investigators
Study Chair: Boehringer Ingelheim Study Coordinator Boehringer Ingelheim Shanghai
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00239395     History of Changes
Other Study ID Numbers: 107.265
Study First Received: October 13, 2005
Last Updated: October 31, 2013
Health Authority: China: 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 September 18, 2014