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

Purpose

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.

Condition	Intervention	Phase
Pain	Drug: AZD1386 Drug: Placebo	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Osteoarthritis

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome 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. ] [ Designated as safety issue: No ]
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 Outcome 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. ] [ Designated as safety issue: No ]
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. ] [ Designated as safety issue: No ]
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. ] [ Designated as safety issue: No ]
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.

Enrollment:	241
Study Start Date:	March 2009
Study Completion Date:	July 2009
Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: AZD1386, 90 mg	Drug: AZD1386 oral, during 4 weeks
Experimental: AZD1386, 30 mg	Drug: AZD1386 oral, during 4 weeks
Placebo Comparator: Placebo	Drug: Placebo Oral, during 4 weeks

Eligibility

Ages Eligible for Study:	40 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00878501

Show 41 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:	Richard L Leff, MD	AZD1386AstraZeneca R&D Wilmington, USA
Study Chair:	Ola Svensson, MD	AZD1386AstraZeneca R&D Södertälje, Sweden

More Information

No publications provided

Responsible Party:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00878501 History of Changes
Other Study ID Numbers:	D5090C00019
Study First Received:	April 8, 2009
Results First Received:	January 27, 2011
Last Updated:	May 28, 2012
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency Canada: Health Canada Finland: Finnish Medicines Agency Bulgaria: Bulgarian Drug Agency Hungary: National Institute of Pharmacy Poland: Ministry of Health Slovakia: State Institute for Drug Control

Keywords provided by AstraZeneca:

Phase II
Pain

Additional relevant MeSH terms:

Osteoarthritis
Osteoarthritis, Knee
Arthritis

Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on May 22, 2013

Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of AZD1386 in Patients With Osteoarthritis (OA) of the Knee (OA19)