Study to Assess the Efficacy and Safety of Meloxicam vs. Diclofenac SR in Patients With Osteoarthritis of the Knee

Osteoarthritis Clinical Trial

Official title:

Open Label Study to Assess the Efficacy and Safety of Meloxicam 7.5mg vs. Diclofenac 100mg SR in Patients With Osteoarthritis of the Knee

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02183129
• Other study ID #: 107.229
• Status: Completed
• Phase: Phase 4
• Start date: April 1, 1999

Study information

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

Clinical Trial Summary

To assess the efficacy and safety of meloxicam 7.5mg once daily compared with diclofenac 100mg SR once daily over a treatment period of 8 weeks

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. primary completion date: November 1, 1999
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Osteoarthritis of the knee requiring the therapy with non-steroidal anti-inflammatory drugs (NSAIDs)

Exclusion Criteria:

• none

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• Diclofenac

• Meloxicam

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in pain on active movement assessed by a 100 mm visual analogue Scale (VAS)		Baseline, 8 weeks after first drug administration
Secondary	Change from baseline in Lequesne index		Baseline, 8 weeks after first drug administration
Secondary	Change from baseline in global assessment by the patient and doctor on a 3-point scale		Baseline, 8 weeks after first drug administration
Secondary	Number of patients with significant changes from baseline in Laboratory values		Baseline, 8 weeks after first drug administration
Secondary	Number of patients with significant changes from baseline in physical examinations		Baseline, 8 weeks after first drug administration
Secondary	Number of patients with Adverse Events		Up to 8 weeks after first drug administration