NCT07319728

Brief Summary

A single blind randomized controlled clinical study

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P50-P75 for phase_1 knee-osteoarthritis

Timeline
Completed

Started May 2025

Shorter than P25 for phase_1 knee-osteoarthritis

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

May 10, 2025

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

December 21, 2025

Completed
11 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 6, 2026

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

January 6, 2026

Status Verified

April 1, 2025

Enrollment Period

8 months

First QC Date

December 21, 2025

Last Update Submit

December 21, 2025

Conditions

Knee Osteoarthritis

Keywords

knee joint osteoarthritisTransdermal Ketoprofen Gel

Outcome Measures

Primary Outcomes (2)

  • Visual Analogue Scale (VAS)

    2 weeks

  • McMaster Universities Arthritis Index (WOMAC)

    2 weeks

Study Arms (2)

formulation arm

EXPERIMENTAL

new formulation of ketoprofen

Drug: ketoprofen

commercial product

ACTIVE COMPARATOR

positive control receiving commercial product

Drug: ketoprofen

Interventions

ketoprofenDRUG

new gel formulation

formulation arm

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient diagnosed with osteoarthritis in knee by:
  • Full history taking Physical examination including (joint tenderness, swelling, crepitus and limitation of motion).

You may not qualify if:

  • \. Patients with dual diagnosis 2. Patients have skin lesion or dermatologic disease in the treatment area

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Minia University

Minya, Minya Governorate, 11666, Egypt

Location

Related Publications (1)

  • Wang Y, Fan M, Wang H, You Y, Wei C, Liu M, Luo A, Xu X, Duan X. Relative safety and efficacy of topical and oral NSAIDs in the treatment of osteoarthritis: A systematic review and meta-analysis. Medicine (Baltimore). 2022 Sep 9;101(36):e30354. doi: 10.1097/MD.0000000000030354.

    PMID: 36086745BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Ketoprofen

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

PhenylpropionatesAcids, CarbocyclicCarboxylic AcidsOrganic Chemicals

Study Officials

  • Sara A Hassan

    Badr University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor Clinical pharmacy department

Study Record Dates

First Submitted

December 21, 2025

First Posted

January 6, 2026

Study Start

May 10, 2025

Primary Completion

January 1, 2026

Study Completion

February 1, 2026

Last Updated

January 6, 2026

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)