Novel Transdermal Ketoprofen Gel Formulation for Knee Osteoarthritis

NCT ID: NCT07319728

Last Updated: 2026-01-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-10

Study Completion Date

2026-02-28

Brief Summary

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A single blind randomized controlled clinical study

Detailed Description

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A single blind randomized controlled clinical study

Conditions

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Knee Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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formulation arm

new formulation of ketoprofen

Group Type EXPERIMENTAL

ketoprofen

Intervention Type DRUG

new gel formulation

commercial product

positive control receiving commercial product

Group Type ACTIVE_COMPARATOR

ketoprofen

Intervention Type DRUG

commercial gel

Interventions

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ketoprofen

new gel formulation

Intervention Type DRUG

ketoprofen

commercial gel

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patient diagnosed with osteoarthritis in knee by:

Full history taking Physical examination including (joint tenderness, swelling, crepitus and limitation of motion).

Exclusion Criteria

* 1\. Patients with dual diagnosis 2. Patients have skin lesion or dermatologic disease in the treatment area
Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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New Valley University

OTHER

Sponsor Role lead

Responsible Party

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Asmaa Ahmed Hamed Mohie Eldin

Associate professor Clinical pharmacy department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sara A Hassan

Role: PRINCIPAL_INVESTIGATOR

Badr University

Locations

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Minia University

Minya, Minya Governorate, Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type BACKGROUND
PMID: 36086745 (View on PubMed)

Other Identifiers

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Minia University

Identifier Type: -

Identifier Source: org_study_id

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