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

Pain Clinical Trial

— OA19  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00878501
• Other study ID #: D5090C00019
• Status: Terminated
• Phase: Phase 2
• First received: April 8, 2009
• Last updated: May 28, 2012
• Start date: March 2009
• Est. completion date: July 2009

Study information

• Verified date: May 2012
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices AgencyCanada: Health CanadaFinland: Finnish Medicines AgencyBulgaria: Bulgarian Drug AgencyHungary: National Institute of PharmacyPoland: Ministry of HealthSlovakia: State Institute for Drug Control
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 241
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Osteoarthritis
• Pain

Intervention

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

Locations

Country	Name	City	State
Bulgaria	Research Site	Pleven
Bulgaria	Research Site	Sofia
Canada	Research Site	Bay Roberts	Newfoundland and Labrador
Canada	Research Site	Brampton	Ontario
Canada	Research Site	Charlottetown	Prince Edward Island
Canada	Research Site	Etobicoke	Ontario
Canada	Research Site	Halifax	Nova Scotia
Canada	Research Site	Hamilton	Ontario
Canada	Research Site	Newmarket	Ontario
Canada	Research Site	Saint Romuald	Quebec
Canada	Research Site	Sherbrooke	Quebec
Canada	Research Site	St Catharines	Ontario
Canada	Research Site	St.Johns	Newfoundland and Labrador
Finland	Research Site	Helsinki
Finland	Research Site	Hyvinkaa
Finland	Research Site	Lahti
Finland	Research Site	Riihimaki
Finland	Research Site	Tampere
Finland	Research Site	Vantaa
Hungary	Research Site	Bekescsaba
Hungary	Research Site	Budapest
Hungary	Research Site	Debrecen
Hungary	Research Site	Miskolc
Hungary	Research Site	Nyiregyhaza
Hungary	Research Site	Veszprem
Japan	Research Site	Japan
Poland	Research Site	Bialystok
Poland	Research Site	Elblag
Poland	Research Site	Gdynia
Poland	Research Site	Krakow
Poland	Research Site	Lublin
Poland	Research Site	Toru
Poland	Research Site	Warszawa
Slovakia	Research Site	Brastislava
Slovakia	Research Site	Komarno
Slovakia	Research Site	Liptovsky Hradok
Slovakia	Research Site	Poprad
Slovakia	Research Site	Povazska Bystrica
Slovakia	Research Site	Rimavska Sobota
Slovakia	Research Site	Ziar nad Hronom
Slovakia	Research Site	Zilina

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

Bulgaria,  Canada,  Finland,  Hungary,  Japan,  Poland,  Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean of Week 2 and Week 4 Changes From Baseline in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain Subscale, 48 Hours Recall.	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.	Baseline, week 2, week 4.	No
Secondary	Mean of Week 2 and Week 4 Changes From Baseline in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Function Subscale, 48 Hours Recall.	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.	Baseline, Week 2 and Week 4.	No
Secondary	Mean of Week 2 and Week 4 Changes From Baseline in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Stiffness Subscale, 48 Hours Recall.	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.	Baseline, Week 2 and Week 4.	No
Secondary	Mean of Week 2 and Week 4 Changes From Baseline in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Total Score, 48 Hours Recall	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.	Baseline, Week 2 and Week 4.	No