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

Phase 3

Completed

• Conditions: Spondylitis, Ankylosing
• Interventions: Drug: Meloxicam suppository; Drug: Meloxicam tablet; Drug: Indomethacin

• Registration Number: NCT02183168
• Lead Sponsor: Boehringer Ingelheim

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

Detailed Description

Not available

Study Timeline

• Study Start: 2001-07-01
• Primary Completion: 2002-05-01
• Study First Submitted: 2014-07-04
• Study First Submitted QC: 2014-07-04
• Study First Posted: 2014-07-08
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-22
• Last Update Posted: 2023-11-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 192

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Meloxicam suppository	Meloxicam suppository	-
Meloxicam tablet	Meloxicam tablet	-
Indomethacin suppository	Indomethacin	-

Primary Outcome Measures

Name	Time	Method
Functional Index of ankylosing spondylitis of Dougados	6 weeks
Overall assessment of disease activity by the patient on VAS	6 weeks
Overall pain during the previous 48 hours assessed on a Visual Analogue Scale (VAS)	6 weeks

Secondary Outcome Measures

Name	Time	Method
Assessment of Fingers - to - floor test	6 weeks
Assessment of Chest expansion	6 weeks
Global efficacy assessed by the investigator (verbal rating scale)	6 weeks
Duration of morning stiffness	6 weeks
Global efficacy assessed by the patient (verbal rating scale)	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
Overall assessment of disease activity by the investigator on a VAS	6 weeks
Evaluation of spinal pain by the investigator (verbal rating scale)	6 weeks
Assessment of Schober test	6 weeks
Assessment of Night pain (verbal rating scale)	6 weeks
Total number of study withdrawals	6 weeks