Comparative Study of Olive Oil With Piroxicam Gel in Osteoarthritis of the Knee

NCT00670475 | Completed Phase 2 DMC

• 1 other identifier: 1/86010
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

this is a randomized double blinded trial which is conducted to measure the efficacy of topical virgin olive oil on osteoarthritis of knee that will be done in contrast to standard piroxicam gel.

Conditions

Osteoarthritis of the Knee

Keywords

osteoarthritis; Knee; virgin olive oil; piroxicam; Topical

Outcome Measures

Primary Outcomes (4)

• The primary outcome measures is defined as the change from baseline to final assessment of the study knee in the 3 core continuous variables pain and physical function, assessing using the WOMAC subscales, and patient global assessment (PGA).

  the outcome is assessed at week 1

• The primary outcome measures is defined as the change from baseline to final assessment of the study knee in the 3 core continuous variables pain and physical function, assessing using the WOMAC subscales, and patient global assessment (PGA).

  the outcome is assessed at week 2

• The primary outcome measures is defined as the change from baseline to final assessment of the study knee in the 3 core continuous variables pain and physical function, assessing using the WOMAC subscales, and patient global assessment (PGA).

  the outcome is assessed at week 3

• The primary outcome measures is defined as the change from baseline to final assessment of the study knee in the 3 core continuous variables pain and physical function, assessing using the WOMAC subscales, and patient global assessment (PGA).

  the outcome is assessed at week 4

Secondary Outcomes (4)

• the secondary measure will be changes in stiffness

  the outcome is assessed at week 1

• the secondary measure will be changes in stiffness

  the outcome is assessed at week 2

• the secondary measure will be changes in stiffness

  the outcome is assessed at week 3

• the secondary measure will be changes in stiffness

  the outcome is assessed at week 4

Study Arms (2)

P (Pircoxicam Group)

ACTIVE COMPARATOR

in this arm 100 patients with osteoarthritis of knee will receive piroxicam gel in blinded 60 grams tubes,they will be instructed to use 1 gram of piroxicam gel (with inserted dispensing device) three times in a day on the affected knee.

Drug: Piroxicam

O (olive oil group)

EXPERIMENTAL

in this arm 100 patients with osteoarthritis of knee will receive virgin olive oil in blinded 60 grams tubes,they will be instructed to use 1 gram of olive oil (with inserted dispensing device) three times in a day on the affected knee.

Dietary Supplement: Olive Oil

Interventions

Piroxicam DRUG

In this interventional arm gel of piroxicam (manufactured by Iran najo co,Iran), repackaged in a 60 g anonymous tubes will be administered to the patients.

Also known as: Piroxicam topical gel

P (Pircoxicam Group)

Olive Oil DIETARY_SUPPLEMENT

virgin olive oil prepared directly from olive fruit from "olive gardens of north of iran, Gilan province" will packaged in a 60 g anonymous tubes.

Also known as: Topical virigin olive oil

O (olive oil group)

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• men and non-pregnant women, age 40-85 years with primary OA of at least one knee, and a flare of pain after withdrawal of prior therapy with either an oral NSAID or acetaminophen (used at least 3 days per week during the previous month).

You may not qualify if:

• secondary arthritis related to systemic inflammatory arthritis (including rheumatoid arthritis, psoriatic arthritis, post-infectious arthritis and metabolic arthritis, traumatic arthritis or surgical joint replacement); corticosteroid use:
• oral corticosteroid within the previous 14 days, or
• intramuscular corticosteroid within 30 days, or
• intraarticular corticosteroid into the study knee within 90 days,
• intra-articular corticosteroid into any other joint within 30 days, or
• topical corticosteroid at the site of application within 14 days;
• ongoing use of prohibited medication including NSAID, other oral analgesic, muscle relaxant, or low-dose antidepressant for any chronic pain management; - ongoing use of glucosamine or chondroitin (unless used continuously for 90 days prior to study entry);
• sensitivity to diclofenac, acetylsalicylic acid (ASA) or any other NSAID, acetaminophen, dimethyl sulphoxide, propylene glycol, glycerine or ethanol; clinically-active renal, hepatic or peptic ulcer disease;
• history of alcohol or drug abuse;
• lactation;
• concomitant skin disease at the application site;
• current application for disability benefits on the basis of knee osteoarthritis; fibromyalgia; other painful or disabling condition affecting the knee;

Sponsors & Collaborators

• Ardabil University of Medical Sciences: lead

Study Sites (1)

ArdabiUMS clinic of rheumatology

Ardabil, Ardabil Province, 56197, Iran

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Interventions

Piroxicam; Olive Oil

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Thiazines; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fats, Unsaturated; Plant Oils; Oils; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• shahab bohlooli, PhD

  Pharmacology Dept, Faculty of Medicine, ArdabilUMS

  PRINCIPAL INVESTIGATOR

• Marina Jastan, MD

  rheomatology clinic, faculty of medicine, ArdabilUMS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 29, 2008
• First Posted: May 1, 2008
• Study Start: April 1, 2008
• Primary Completion: May 1, 2009
• Study Completion: April 1, 2010
• Last Updated: April 29, 2010

Record last verified: 2010-04

Locations

IR (1)