A Study to Access the Efficacy and Safety of Meloxicam in Patients With Osteoarthritis of the Knee

Osteoarthritis Clinical Trial

Official title:

Open Study to Access the Efficacy and Safety of Meloxicam 7.5mg in Patients With Osteoarthritis of the Knee

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02183116
• Other study ID #: 107.228
• Status: Completed
• Phase: Phase 4
• First received: July 4, 2014
• Last updated: July 4, 2014
• Start date: October 1998

Study information

• Verified date: July 2014
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry for Health and Welfare
• Study type: Interventional

Clinical Trial Summary

To Access the Efficacy and Safety of Meloxicam 7.5mg once daily over a treatment period of 56 days

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. primary completion date: February 1999
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 34 Years to 74 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• 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 (100 mm, VAS)		Baseline, 8 weeks after first drug administration	No
Secondary	Change from baseline in Lequesne index		Baseline, 8 weeks after first drug administration	No
Secondary	Change from baseline in physical examination (tenderness)		Baseline, 8 weeks after first drug administration	No
Secondary	Assessment of significant change from baseline in status according endoscopy		Baseline, 8 weeks after first drug administration	No
Secondary	Assessment of significant change from baseline in gastrointestinal (GI) symptoms score		Baseline, 8 weeks after first drug administration	No
Secondary	Assessment of significant change from baseline in laboratory values		Baseline, 8 weeks after first drug administration	No
Secondary	Number of Patients with Adverse Events		Up to 8 weeks after first drug administration	No
Secondary	Assessment of significant change from baseline in physical examination (swelling)		Baseline, 8 weeks after treatment	No

External Links

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