Proof-of Concept Study of Topical 3%-Diclofenac-Nano-Emulsion Cream for Knee OA Pain

NCT00484120 | Completed Phase 2 DMC

• 1 other identifier: PH-2007-2
• Study Type: interventional
• Target: 123
• Locations: 1 country
• Sites: 4

Brief Summary

This study valuates the safety and efficacy of treatment with 3% Diclofenac Nano-Emulsion Cream versus Placebo in subjects with osteoarthritis of the knee.

Conditions

Osteoarthritis of the Knee

Keywords

Osteoarthritis; Diclofenac; Nano-emulsion

Outcome Measures

Primary Outcomes (1)

• Analgesic activity as measured by the WOMAC pain subscale.

  1 month

Secondary Outcomes (3)

• Patient's daily pain assessment in the home diary.

  1 month

• Pain on walking.

  1 month

• Safety and Tolerability.

  1 month

Study Arms (2)

1

EXPERIMENTAL

3% Diclofenac NE cream

Drug: 3%-Diclofenac-Nano-Emulsion Cream

2

PLACEBO COMPARATOR

Drug: Placebo cream

Interventions

3%-Diclofenac-Nano-Emulsion Cream DRUG

3%-Diclofenac-Nano-Emulsion Cream

1

Placebo cream DRUG

Placebo cream

2

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females 50 years of age and above.
• Patients with primary osteoarthritis in at least a single knee joint, grade 2 or 3 based on the Kellgren and Lawrence classification system.
• Radiographic evidence consistent with OA carried out within the 6 months before screening.
• Pain should have been present for at least half of the days in the previous month and for at least 48h prior to the screening visit.
• Eligible subjects must have used an oral, topical or rectal NSAID within the past 6 months before screening.
• At baseline, after a 1 week withdrawal period of analgesic/anti-inflammatory medications, subjects should have a flare of pain.
• Able to read, comprehend, and sign the consent form.
• Examined by the authorized physician and medically cleared to participate in the study.
• In general good health and have no contraindications to any of the investigational medicinal products.

You may not qualify if:

• Secondary osteoarthritis.
• Presence of a serious or unstable medical condition (e.g., malignancy, severe neurological impairment or uncontrolled hypertension) or poor general health interfering with compliance or assessment at the study physician's discretion.
• OA causing significant pain in any joint other than the knees.
• Any other rheumatic or non-rheumatic joint disease or any other painful condition within the past month (e.g. fibromyalgia).
• Knee surgery or other knee trauma at any time during the previous year or subjects for whom a treatment is planned within the study period that could alter the degree or nature of pain (e.g. arthroscopic techniques, osteotomy, joint replacement surgery etc.).
• Active or history of gastrointestinal ulceration or bleeding within the past 5 years.
• Presence of a significant active psychiatric disorder including major depression or subjects receiving anti-psychotic medication.
• Existence of any dermatological condition on the knee.
• Subjects with disabling congestive heart failure (CHF), angina, pulmonary disease.
• Clinically significant abnormal blood results.
• Subjects cannot have had an arthrocentesis prior or during the study.
• Concomitant treatment with physical and/or occupational therapy.
• Prior use of any type of NSAID or other analgesic before taking the first dose of investigational medicinal product. Rescue treatment will be allowed during the study
• Change in sedative or CNS/psychotropic agent within the past month.
• Chronic treatment with anticoagulants (e.g. Warfarin).

Sponsors & Collaborators

• Pharmos: lead

Study Sites (4)

Barzilai Medical Center

Ashkelon, Israel, 78278, Israel

Location

Rabin Medical Center

Petah Tikva, Israel, 49100, Israel

Location

Rambam Medical Center

Haifa, 9602, Israel

Location

Sourasky Medical Center

Tel Aviv, 64239, Israel

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Eisenberg Elon, MD

  Rambam Health Care Campus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 7, 2007
• First Posted: June 8, 2007
• Study Start: June 1, 2007
• Primary Completion: November 1, 2008
• Study Completion: December 1, 2008
• Last Updated: August 2, 2011

Record last verified: 2011-08

Locations

IL (4)