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

Boehringer Ingelheim

Status and phase: Completed; Phase 3

Conditions: Spondylitis, Ankylosing

Treatments: Drug: Meloxicam tablet; Drug: Meloxicam suppository; Drug: Indomethacin

Study type: Interventional

Funder types: Industry

Identifiers

NCT02183168

107.237

Details and patient eligibility

About

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

Enrollment: 192 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Exclusion criteria

• none

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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192 participants in 3 patient groups

Meloxicam suppository

Experimental group

Treatment:

Drug: Meloxicam suppository

Meloxicam tablet

Experimental group

Treatment:

Drug: Meloxicam tablet

Indomethacin suppository

Active Comparator group

Treatment:

Drug: Indomethacin