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

July 4, 2014 updated by: Boehringer Ingelheim

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 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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

192

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2001

Primary Completion (Actual)

May 1, 2002

Study Registration Dates

First Submitted

July 4, 2014

First Submitted That Met QC Criteria

July 4, 2014

First Posted (Estimate)

July 8, 2014

Study Record Updates

Last Update Posted (Estimate)

July 8, 2014

Last Update Submitted That Met QC Criteria

July 4, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 107.237

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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