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 Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Spondylitis, Ankylosing

Intervention / Treatment
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* Drug: Meloxicam suppository
* Drug: Meloxicam tablet
* Drug: Indomethacin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Meloxicam suppository<br> | Drug: Meloxicam suppository<br> <br> |
| Experimental: Meloxicam tablet<br> | Drug: Meloxicam tablet<br> <br> |
| Active Comparator: Indomethacin suppository<br> | Drug: Indomethacin<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall pain during the previous 48 hours assessed on a Visual Analogue Scale (VAS) |  | 6 weeks | 
| Functional Index of ankylosing spondylitis of Dougados |  | 6 weeks | 
| Overall assessment of disease activity by the patient on VAS |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall assessment of disease activity by the investigator on a VAS |  | 6 weeks | 
| Global efficacy assessed by the patient (verbal rating scale) |  | 6 weeks | 
| Global efficacy assessed by the investigator (verbal rating scale) |  | 6 weeks | 
| Duration of morning stiffness |  | 6 weeks | 
| Evaluation of spinal pain by the investigator (verbal rating scale) |  | 6 weeks | 
| Assessment of Schober test |  | 6 weeks | 
| Assessment of Chest expansion |  | 6 weeks | 
| Assessment of Fingers - to - floor test |  | 6 weeks | 
| Assessment of Night pain (verbal rating scale) |  | 6 weeks | 
| Total number of study withdrawals |  | 6 weeks | 
| Number of study withdrawals due to lack of efficacy |  | 6 weeks | 
| Assessment of Paracetamol consumption |  | 6 weeks | 
| Assessment of Patient status with regard to disease condition |  | 6 weeks |