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

Primary Purpose

Osteoarthritis

Status

Completed

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

Meloxicam

About this trial

This is an interventional treatment trial for Osteoarthritis

Eligibility Criteria

34 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

none

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Meloxicam

Arm Description

Outcomes

Primary Outcome Measures

Change from baseline in pain on active movement assessed by a 100 mm visual analogue scale (100 mm, VAS)

Secondary Outcome Measures

Change from baseline in Lequesne index

Change from baseline in physical examination (tenderness)

Assessment of significant change from baseline in status according endoscopy

Assessment of significant change from baseline in gastrointestinal (GI) symptoms score

Assessment of significant change from baseline in laboratory values

Number of Patients with Adverse Events

Assessment of significant change from baseline in physical examination (swelling)

Full Information

NCT ID

NCT02183116

First Posted

July 4, 2014

Last Updated

July 4, 2014

Sponsor

Boehringer Ingelheim

1. Study Identification

Unique Protocol Identification Number

NCT02183116

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2014

Overall Recruitment Status

Completed

Study Start Date

October 1998 (undefined)

Primary Completion Date

February 1999 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Boehringer Ingelheim

4. Oversight

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoarthritis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Meloxicam

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Meloxicam

Other Intervention Name(s)

Mobic

Primary Outcome Measure Information:

Title

Change from baseline in pain on active movement assessed by a 100 mm visual analogue scale (100 mm, VAS)

Time Frame