NCT02183129

Brief 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

Trial Health

100
On Track

Trial Health Score

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

Enrollment
91

participants targeted

Target at P50-P75 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

April 1, 1999

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 1999

Completed
14.7 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

November 24, 2023

Status Verified

November 1, 2023

Enrollment Period

7 months

First QC Date

July 4, 2014

Last Update Submit

November 22, 2023

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Change from baseline in Lequesne index

    Baseline, 8 weeks after first drug administration

  • Change from baseline in global assessment by the patient and doctor on a 3-point scale

    Baseline, 8 weeks after first drug administration

  • Number of patients with significant changes from baseline in Laboratory values

    Baseline, 8 weeks after first drug administration

  • Number of patients with significant changes from baseline in physical examinations

    Baseline, 8 weeks after first drug administration

  • Number of patients with Adverse Events

    Up to 8 weeks after first drug administration

Study Arms (2)

Meloxicam

EXPERIMENTAL
Drug: Meloxicam

Diclofenac

ACTIVE COMPARATOR
Drug: Diclofenac

Interventions

DiclofenacDRUG
Diclofenac
MeloxicamDRUG
Meloxicam

Eligibility Criteria

Age18 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

DiclofenacMeloxicam

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

PhenylacetatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsThiazinesSulfur CompoundsThiazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 4, 2014

First Posted

July 8, 2014

Study Start

April 1, 1999

Primary Completion

November 1, 1999

Last Updated

November 24, 2023

Record last verified: 2023-11