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

Sponsor

Boehringer Ingelheim (Industry)

Overall Status

Completed

CT.gov ID

NCT02183168

Collaborator

(none)

192

Enrollment

Arms

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Spondylitis, Ankylosing	Drug: Meloxicam suppository Drug: Meloxicam tablet Drug: Indomethacin	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

192 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Jul 1, 2001

Actual Primary Completion Date :

May 1, 2002

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Meloxicam suppository	Drug: Meloxicam suppository
Experimental: Meloxicam tablet	Drug: Meloxicam tablet
Active Comparator: Indomethacin suppository	Drug: Indomethacin

Arm

Intervention/Treatment

Experimental: Meloxicam suppository

Drug: Meloxicam suppository

Experimental: Meloxicam tablet

Drug: Meloxicam tablet

Active Comparator: Indomethacin suppository

Drug: Indomethacin

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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