A Study to Compare Meloxicam IM Once Daily Versus Meloxicam Orally Once Daily in Patients With Rheumatoid Arthritis

Arthritis, Rheumatoid Clinical Trial

Official title:

A Randomized, Open-labelled Study to Compare the Efficacy and Safety of Meloxicam 15 mg IM Ampoules Once Daily and Meloxicam 15 mg Tablets Administered Orally Once Daily Over a Period of 7 Days in Patients With RA.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00239382
• Other study ID #: 107.266
• Status: Completed
• Phase: Phase 3
• Start date: July 1, 2004
• Est. completion date: December 31, 2004

Study information

• Verified date: July 2018
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this trial was to assess the efficacy and safety of 15 mg meloxicam i.m. once daily compared with 15 mg meloxicam tablets once daily p.o. in patients with Rheumatoid arthritis over a time period of 7 days.

Description:

This was a randomized (1:1), open-label, multi-center, active-control, parallel-group study to compare the efficacy of 15 mg meloxicam i.m. once daily compared with 15 mg meloxicam tablets once daily p.o. in patients with rheumatoid arthritis over a time period of 7 days.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: December 31, 2004
• Est. primary completion date: December 1, 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male or female aged 18 years or above

• The patient has rheumatoid arthritis, as defined by the American Rheumatism Association.

• Assessment of overall pain (by the patient), after a washout for NSAID of at least 2 days (3 days for oxicams), must exceed 40 mm on a 100 mm visual analogue scale (VAS)

• Symptoms of RA requiring administration of NSAIDs

• Outpatients

• 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 previous 6 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 methotrexate, sulfasalazine, D-penicillamine, chloroquine or any other disease modifying antirheumatic drug initiated or with an altered dose over the previous 3 months

• 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

• Synovectomy and/or surgical treatment for RA in the previous month or during the trial

• Any physiotherapy which will be changed during the trial

• 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 amino-transferase (AST/SGOT) and/or alaline amino-transferase (ALT/SGPT) 200 % of the upper limit of normal range

• Platelet count < 100,000/mm3 ; leucocytes count < 3,000/mm3

• Participation in another clinical trial during this study or during the previous month

• Previous participation in this trial (i.e. having been allocated a randomized treatment number)

• Patient unable to comply with the protocol

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid

Intervention

Drug:
• Meloxicam ampoule

• Meloxicam tablet

Locations

Country	Name	City	State
China	Beijing Xuan Wu Hospital	Beijing
China	People's Hospital, Beijing University	Beijing
China	1st Affiliated, Anhui Medical University	Hefei City, Anhui Province
China	Qilu Hospital, Shang Dong University	Nan City
China	Shanghai Changhai Hospital	Shanghai
China	Shanghai Guanghai Hospital	Shanghai
China	Shanghai Renji Hospital	Shanghai
China	Shanghai Zhongshan Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient's assessment of overall pain		7 days
Primary	Patient's global assessment of disease activity		7 days
Secondary	Investigator's Global Assessment of Disease Activity		7 days
Secondary	Tender/Painful Joint Count		7 days
Secondary	Swollen Joint Count		7 days
Secondary	Duration of Morning Stiffness		7 days
Secondary	Patient's assessment of physical function		7 days
Secondary	Final Global Assessment of Efficacy by Patient		7 days
Secondary	Final Global Assessment of Efficacy by Investigator		7 days
Secondary	Withdrawals due to Inadequate Efficacy		7 days
Secondary	Change in Patient Status With Regard to Arthritic Condition as Assessed by the Patient		7 days
Secondary	Change in Patient Status With Regard to Arthritic Condition as Assessed by the Investigator		7 days
Secondary	Onset of Analgesic Action		7 days
Secondary	Time to Maximum Pain Relief After the First Trial Drug Administration		7 days
Secondary	Paracetamol Consumption		7 days