Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of AZD1386 in Patients With Osteoarthritis (OA) of the Knee

Overview

The primary aim of this study is to investigate if AZD1386 is efficacious as an analgesic in patients with osteoarthritis of the knee and at what dose. This will be done by comparing the effect of AZD1386 to placebo ("inactive substance") on pain.

Full Title of Study: “A Phase II Randomised, Double-blind, Parallel Group, 4-week Treatment, Adaptive Dose Finding, Multi-centre Study Evaluating the Efficacy, Safety, Tolerability and Pharmacokinetics of up to Three Different Oral Doses of AZD1386 and Placebo in Patients With Osteoarthritis of the Knee”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: July 2009

Interventions

  • Drug: AZD1386
    • oral, during 4 weeks
  • Drug: AZD1386
    • oral, during 4 weeks
  • Drug: Placebo
    • Oral, during 4 weeks

Arms, Groups and Cohorts

  • Experimental: AZD1386, 90 mg
  • Experimental: AZD1386, 30 mg
  • Placebo Comparator: Placebo

Clinical Trial Outcome Measures

Primary Measures

  • Mean of Week 2 and Week 4 Changes From Baseline in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain Subscale, 48 Hours Recall.
    • Time Frame: Baseline, week 2, week 4.
    • The WOMAC pain subscale is a self-administered electronic scale with 5 questions (Walking on flat surface, Going up or down stairs, At night while in bed, Sitting or lying, Standing upright). Responses were recorded on a 50-mm line with 100 units. 0 mm indicated no pain and 50 mm indicated extreme pain. The scores were then converted to a 100-mm scale. WOMAC pain was derived by calculating the mean of the VAS scores from the 5 questions with score scale ranging from 0 to 100, 0 being no pain and 100 extreme pain.

Secondary Measures

  • Mean of Week 2 and Week 4 Changes From Baseline in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Function Subscale, 48 Hours Recall.
    • Time Frame: Baseline, Week 2 and Week 4.
    • The WOMAC VA 3.1. is a self-administered electronic questionnaire that assesses pain, stiffness and disability related to OA. The Function (daily activities) subscale consists of 17 questions. WOMAC function was derived by calculating the mean of the VAS scores from the 17 questions with scores ranging from 0 to 100, 0 = no difficulty in performing daily activities and 100 = extreme difficulty.
  • Mean of Week 2 and Week 4 Changes From Baseline in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Stiffness Subscale, 48 Hours Recall.
    • Time Frame: Baseline, Week 2 and Week 4.
    • The WOMAC VA3.1. is a self-administered questionnaire that assesses pain, stiffness and disability related to osteoarthritis. The Stiffness subscale consists of 2 questions (Severity of stiffness after first awakening in the morning and severity of stiffnes after periods of inactivity later in the day). WOMAC stiffness was derived by calculating the mean of the VAS scores from the 2 questions with score scale ranging from 0 to 100, 0 being no stiffness and 100 extreme stiffness.
  • Mean of Week 2 and Week 4 Changes From Baseline in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Total Score, 48 Hours Recall
    • Time Frame: Baseline, Week 2 and Week 4.
    • The WOMAC VA3.1. is a self-administered questionnaire that assesses pain, stiffness and disability related to osteoarthritis. It consists of a pain subscale (5 questions), function subscale (17 questions). and a stiffness subscale (2 questions). The total score was derived by calculating the mean of the VAS scores from all 24 questions with score scale ranging from 0 to 100, 0 being no pain, stiffness and difficulty in performing daily activities and 100 being extreme pain, stiffness and difficulty in performing daily activities.

Participating in This Clinical Trial

Inclusion Criteria

  • Patients with OA of the knee – Male or non pregnant females 40 and 80 years old Exclusion Criteria:

  • A current diagnosis of another form of arthritis, in addition to OA – History, and/or presence of somatic disease, which may interfere with the objectives

Gender Eligibility: All

Minimum Age: 40 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • AstraZeneca
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Richard L Leff, MD, Study Director, AZD1386AstraZeneca R&D Wilmington, USA
    • Ola Svensson, MD, Study Chair, AZD1386AstraZeneca R&D Södertälje, Sweden

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