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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

NCT ID: NCT02183168

Last Updated: 2023-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

192 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-07-01

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

Detailed Description

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Conditions

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Spondylitis, Ankylosing

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Meloxicam suppository

Group Type EXPERIMENTAL

Meloxicam suppository

Intervention Type DRUG

Meloxicam tablet

Group Type EXPERIMENTAL

Meloxicam tablet

Intervention Type DRUG

Indomethacin suppository

Group Type ACTIVE_COMPARATOR

Indomethacin

Intervention Type DRUG

Interventions

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Meloxicam suppository

Intervention Type DRUG

Meloxicam tablet

Intervention Type DRUG

Indomethacin

Intervention Type DRUG

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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107.237

Identifier Type: -

Identifier Source: org_study_id