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NCT02183168 Clinical Trial

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

Spondylitis, Ankylosing Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02183168
Other study ID # 107.237
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date July 1, 2001

Study information
Verified date November 2023
Source Boehringer Ingelheim
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 192
Est. completion date
Est. primary completion date May 1, 2002
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Meloxicam suppository

• Meloxicam tablet

• Indomethacin

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Boehringer Ingelheim

Outcome
Type Measure Description Time frame Safety issue
Primary Overall pain during the previous 48 hours assessed on a Visual Analogue Scale (VAS) 6 weeks
Primary Functional Index of ankylosing spondylitis of Dougados 6 weeks
Primary Overall assessment of disease activity by the patient on VAS 6 weeks
Secondary Overall assessment of disease activity by the investigator on a VAS 6 weeks
Secondary Global efficacy assessed by the patient (verbal rating scale) 6 weeks
Secondary Global efficacy assessed by the investigator (verbal rating scale) 6 weeks
Secondary Duration of morning stiffness 6 weeks
Secondary Evaluation of spinal pain by the investigator (verbal rating scale) 6 weeks
Secondary Assessment of Schober test 6 weeks
Secondary Assessment of Chest expansion 6 weeks
Secondary Assessment of Fingers - to - floor test 6 weeks
Secondary Assessment of Night pain (verbal rating scale) 6 weeks
Secondary Total number of study withdrawals 6 weeks
Secondary Number of study withdrawals due to lack of efficacy 6 weeks
Secondary Assessment of Paracetamol consumption 6 weeks
Secondary Assessment of Patient status with regard to disease condition 6 weeks
See also
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