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Completed

NCT Number: NCT02183168

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

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Key information

Conditions

Spondylitis, Ankylosing Ankylosis Arthritis Axial Spondyloarthritis Bone Diseases Joint Diseases Musculoskeletal Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Meloxicam suppository

Drug

Meloxicam tablet

Drug

Indomethacin

Drug

Primary outcomes

  1. Overall pain during the previous 48 hours assessed on a Visual Analogue Scale (VAS)

    Time frame: 6 weeks

  2. Functional Index of ankylosing spondylitis of Dougados

    Time frame: 6 weeks

  3. Overall assessment of disease activity by the patient on VAS

    Time frame: 6 weeks

Secondary outcomes

  1. Overall assessment of disease activity by the investigator on a VAS

    Time frame: 6 weeks

  2. Global efficacy assessed by the patient (verbal rating scale)

    Time frame: 6 weeks

  3. Global efficacy assessed by the investigator (verbal rating scale)

    Time frame: 6 weeks

  4. Duration of morning stiffness

    Time frame: 6 weeks

  5. Evaluation of spinal pain by the investigator (verbal rating scale)

    Time frame: 6 weeks

  6. Assessment of Schober test

    Time frame: 6 weeks

  7. Assessment of Chest expansion

    Time frame: 6 weeks

  8. Assessment of Fingers - to - floor test

    Time frame: 6 weeks

  9. Assessment of Night pain (verbal rating scale)

    Time frame: 6 weeks

  10. Total number of study withdrawals

    Time frame: 6 weeks

  11. Number of study withdrawals due to lack of efficacy

    Time frame: 6 weeks

  12. Assessment of Paracetamol consumption

    Time frame: 6 weeks

  13. Assessment of Patient status with regard to disease condition

    Time frame: 6 weeks

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study 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

Important dates

Study start
2001
Primary completion
2002
First posted
Jul 8, 2014
Registry last updated
Nov 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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