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

Primary Purpose

Arthritis, Rheumatoid

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Meloxicam ampoule
Meloxicam tablet
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arthritis, Rheumatoid

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • People's Hospital, Beijing University
  • Beijing Xuan Wu Hospital
  • 1st Affiliated, Anhui Medical University
  • Qilu Hospital, Shang Dong University
  • Shanghai Renji Hospital
  • Shanghai Zhongshan Hospital
  • Shanghai Guanghai Hospital
  • Shanghai Changhai Hospital

Outcomes

Primary Outcome Measures

Patient's assessment of overall pain
Patient's global assessment of disease activity

Secondary Outcome Measures

Investigator's Global Assessment of Disease Activity
Tender/Painful Joint Count
Swollen Joint Count
Duration of Morning Stiffness
Patient's assessment of physical function
Final Global Assessment of Efficacy by Patient
Final Global Assessment of Efficacy by Investigator
Withdrawals due to Inadequate Efficacy
Change in Patient Status With Regard to Arthritic Condition as Assessed by the Patient
Change in Patient Status With Regard to Arthritic Condition as Assessed by the Investigator
Onset of Analgesic Action
Time to Maximum Pain Relief After the First Trial Drug Administration
Paracetamol Consumption

Full Information

First Posted
October 13, 2005
Last Updated
August 1, 2018
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT00239382
Brief Title
A Study to Compare Meloxicam IM Once Daily Versus Meloxicam Orally Once Daily in Patients With Rheumatoid Arthritis
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.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
July 1, 2004 (Actual)
Primary Completion Date
December 1, 2004 (Actual)
Study Completion Date
December 31, 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim

4. Oversight

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis, Rheumatoid

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Meloxicam ampoule
Intervention Type
Drug
Intervention Name(s)
Meloxicam tablet
Primary Outcome Measure Information:
Title
Patient's assessment of overall pain
Time Frame
7 days
Title
Patient's global assessment of disease activity
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Investigator's Global Assessment of Disease Activity
Time Frame
7 days
Title
Tender/Painful Joint Count
Time Frame
7 days
Title
Swollen Joint Count
Time Frame
7 days
Title
Duration of Morning Stiffness
Time Frame
7 days
Title
Patient's assessment of physical function
Time Frame
7 days
Title
Final Global Assessment of Efficacy by Patient
Time Frame
7 days
Title
Final Global Assessment of Efficacy by Investigator
Time Frame
7 days
Title
Withdrawals due to Inadequate Efficacy
Time Frame
7 days
Title
Change in Patient Status With Regard to Arthritic Condition as Assessed by the Patient
Time Frame
7 days
Title
Change in Patient Status With Regard to Arthritic Condition as Assessed by the Investigator
Time Frame
7 days
Title
Onset of Analgesic Action
Time Frame
7 days
Title
Time to Maximum Pain Relief After the First Trial Drug Administration
Time Frame
7 days
Title
Paracetamol Consumption
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim Study Coordinator
Organizational Affiliation
Boehringer Ingelheim Shanghai
Official's Role
Study Chair
Facility Information:
Facility Name
People's Hospital, Beijing University
City
Beijing
ZIP/Postal Code
100044
Country
China
Facility Name
Beijing Xuan Wu Hospital
City
Beijing
ZIP/Postal Code
100050
Country
China
Facility Name
1st Affiliated, Anhui Medical University
City
Hefei City, Anhui Province
ZIP/Postal Code
230022
Country
China
Facility Name
Qilu Hospital, Shang Dong University
City
Nan City
ZIP/Postal Code
250012
Country
China
Facility Name
Shanghai Renji Hospital
City
Shanghai
ZIP/Postal Code
200001
Country
China
Facility Name
Shanghai Zhongshan Hospital
City
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
Shanghai Guanghai Hospital
City
Shanghai
ZIP/Postal Code
200052
Country
China
Facility Name
Shanghai Changhai Hospital
City
Shanghai
ZIP/Postal Code
200443
Country
China

12. IPD Sharing Statement

Links:
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/107/107.266_U06-3613.pdf
Description
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A Study to Compare Meloxicam IM Once Daily Versus Meloxicam Orally Once Daily in Patients With Rheumatoid Arthritis

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