Back to resultsEvaluation of Efficacy and Safety of Meloxicam Suppository (15mg Daily) and Tablet (15 mg Daily) Compared to Indomethacin Suppository (50 mg Daily) in Patients With Ankylosing Spondylitis
Primary Purpose
Spondylitis, Ankylosing
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Meloxicam suppository
Meloxicam tablet
Indomethacin
Sponsored by
About this trial
This is an interventional treatment trial for Spondylitis, Ankylosing
Eligibility Criteria
Inclusion Criteria:
- Active ankylosing spondylitis (pain rated >= 40 mm on a VAS and increased of at least 30% after nonsteroidal anti-inflammatory drugs (NSAIDs) wash-out)), without peripheral arthritis and inflammatory bowel disease
Exclusion Criteria:
none
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Meloxicam suppository
Meloxicam tablet
Indomethacin suppository
Arm Description
Outcomes
Primary Outcome Measures
Overall pain during the previous 48 hours assessed on a Visual Analogue Scale (VAS)
Functional Index of ankylosing spondylitis of Dougados
Overall assessment of disease activity by the patient on VAS
Secondary Outcome Measures
Overall assessment of disease activity by the investigator on a VAS
Global efficacy assessed by the patient (verbal rating scale)
Global efficacy assessed by the investigator (verbal rating scale)
Duration of morning stiffness
Evaluation of spinal pain by the investigator (verbal rating scale)
Assessment of Schober test
Assessment of Chest expansion
Assessment of Fingers - to - floor test
Assessment of Night pain (verbal rating scale)
Total number of study withdrawals
Number of study withdrawals due to lack of efficacy
Assessment of Paracetamol consumption
Assessment of Patient status with regard to disease condition
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02183168
Brief Title
Evaluation of Efficacy and Safety of Meloxicam Suppository (15mg Daily) and Tablet (15 mg Daily) Compared to Indomethacin Suppository (50 mg Daily) in Patients With Ankylosing Spondylitis
Official Title
A Randomized, Open Label, 3-arm Evaluation of Efficacy and Safety of Meloxicam Suppository (15mg Daily) and Tablet (15 mg Daily) Compared to Indomethacin Suppository (50 mg Daily) in Patients With Ankylosing Spondylitis
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
July 2001 (undefined)
Primary Completion Date
May 2002 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim
4. Oversight
5. Study Description
Brief Summary
Study to assess the efficacy and safety of meloxicam suppository 15 mg once daily, meloxicam tablet 15 mg once daily compared with Indomethacin suppository (50 mg daily) in patients with ankylosing spondylitis
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spondylitis, Ankylosing
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
192 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Meloxicam suppository
Arm Type
Experimental
Arm Title
Meloxicam tablet
Arm Type
Experimental
Arm Title
Indomethacin suppository
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Meloxicam suppository
Intervention Type
Drug
Intervention Name(s)
Meloxicam tablet
Intervention Type
Drug
Intervention Name(s)
Indomethacin
Primary Outcome Measure Information:
Title
Overall pain during the previous 48 hours assessed on a Visual Analogue Scale (VAS)
Time Frame
6 weeks
Title
Functional Index of ankylosing spondylitis of Dougados
Time Frame
6 weeks
Title
Overall assessment of disease activity by the patient on VAS
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Overall assessment of disease activity by the investigator on a VAS
Time Frame
6 weeks
Title
Global efficacy assessed by the patient (verbal rating scale)
Time Frame
6 weeks
Title
Global efficacy assessed by the investigator (verbal rating scale)
Time Frame
6 weeks
Title
Duration of morning stiffness
Time Frame
6 weeks
Title
Evaluation of spinal pain by the investigator (verbal rating scale)
Time Frame
6 weeks
Title
Assessment of Schober test
Time Frame
6 weeks
Title
Assessment of Chest expansion
Time Frame
6 weeks
Title
Assessment of Fingers - to - floor test
Time Frame
6 weeks
Title
Assessment of Night pain (verbal rating scale)
Time Frame
6 weeks
Title
Total number of study withdrawals
Time Frame
6 weeks
Title
Number of study withdrawals due to lack of efficacy
Time Frame
6 weeks
Title
Assessment of Paracetamol consumption
Time Frame
6 weeks
Title
Assessment of Patient status with regard to disease condition
Time Frame
6 weeks
10. Eligibility
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Active ankylosing spondylitis (pain rated >= 40 mm on a VAS and increased of at least 30% after nonsteroidal anti-inflammatory drugs (NSAIDs) wash-out)), without peripheral arthritis and inflammatory bowel disease
Exclusion Criteria:
none
12. IPD Sharing Statement
Links:
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/107/107.237_U06-3735.pdf
Description
Related Info
Learn more about this trial
Evaluation of Efficacy and Safety of Meloxicam Suppository (15mg Daily) and Tablet (15 mg Daily) Compared to Indomethacin Suppository (50 mg Daily) in Patients With Ankylosing Spondylitis
We'll reach out to this number within 24 hrs