NCT02183116

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 1998

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 1999

Completed
15.4 years until next milestone

First Submitted

Initial submission to the registry

July 4, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 8, 2014

Completed
Last Updated

July 8, 2014

Status Verified

July 1, 2014

Enrollment Period

4 months

First QC Date

July 4, 2014

Last Update Submit

July 4, 2014

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (7)

  • Change from baseline in Lequesne index

    Baseline, 8 weeks after first drug administration

  • Change from baseline in physical examination (tenderness)

    Baseline, 8 weeks after first drug administration

  • Assessment of significant change from baseline in status according endoscopy

    Baseline, 8 weeks after first drug administration

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

    Baseline, 8 weeks after first drug administration

  • Assessment of significant change from baseline in laboratory values

    Baseline, 8 weeks after first drug administration

  • +2 more secondary outcomes

Study Arms (1)

Meloxicam

EXPERIMENTAL
Drug: Meloxicam

Interventions

MeloxicamDRUG
Also known as: Mobic
Meloxicam

Eligibility Criteria

Age34 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Osteoarthritis

Interventions

Meloxicam

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

ThiazinesSulfur CompoundsOrganic ChemicalsThiazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 4, 2014

First Posted

July 8, 2014

Study Start

October 1, 1998

Primary Completion

February 1, 1999

Last Updated

July 8, 2014

Record last verified: 2014-07