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
• Status: Completed
• Phase: Phase 3
• Start date: July 1, 2001

Study information

• Verified date: November 2023
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• 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. 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

Related Conditions & MeSH terms

• Spondylarthritis
• Spondylitis
• Spondylitis, Ankylosing

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