Clinical trial NCT00878501: Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of AZD1386 in Patients With Osteoarthritis (OA) of the Knee
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Pain
Keywords: Phase II
Pain
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-04-09
Enrollment: 241
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: Mean of Week 2 and Week 4 Changes From Baseline in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain Subscale, 48 Hours Recall.
timeFrame: Baseline, week 2, week 4.
Secondary outcomes:
measure: Mean of Week 2 and Week 4 Changes From Baseline in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Function Subscale, 48 Hours Recall.
timeFrame: Baseline, Week 2 and Week 4.
measure: Mean of Week 2 and Week 4 Changes From Baseline in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Stiffness Subscale, 48 Hours Recall.
timeFrame: Baseline, Week 2 and Week 4.
measure: Mean of Week 2 and Week 4 Changes From Baseline in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Total Score, 48 Hours Recall
timeFrame: Baseline, Week 2 and Week 4.
Other outcomes:
Locations:
city: Pleven
country: Bulgaria
facility: Research Site
city: Sofia
country: Bulgaria
facility: Research Site
city: Bay Roberts
country: Canada
facility: Research Site
state: Newfoundland and Labrador
city: St.Johns
country: Canada
facility: Research Site
state: Newfoundland and Labrador
city: Halifax
country: Canada
facility: Research Site
state: Nova Scotia
city: Brampton
country: Canada
facility: Research Site
state: Ontario
city: Etobicoke
country: Canada
facility: Research Site
state: Ontario
city: Hamilton
country: Canada
facility: Research Site
state: Ontario
city: Newmarket
country: Canada
facility: Research Site
state: Ontario
city: St Catharines
country: Canada
facility: Research Site
state: Ontario
city: Charlottetown
country: Canada
facility: Research Site
state: Prince Edward Island
city: Saint Romuald
country: Canada
facility: Research Site
state: Quebec
city: Sherbrooke
country: Canada
facility: Research Site
state: Quebec
city: Helsinki
country: Finland
facility: Research Site
city: Hyvinkaa
country: Finland
facility: Research Site
city: Lahti
country: Finland
facility: Research Site
city: Riihimaki
country: Finland
facility: Research Site
city: Tampere
country: Finland
facility: Research Site
city: Vantaa
country: Finland
facility: Research Site
city: Bekescsaba
country: Hungary
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Debrecen
country: Hungary
facility: Research Site
city: Miskolc
country: Hungary
facility: Research Site
city: Nyiregyhaza
country: Hungary
facility: Research Site
city: Veszprem
country: Hungary
facility: Research Site
city: Japan
country: Japan
facility: Research Site
city: Bialystok
country: Poland
facility: Research Site
city: Elblag
country: Poland
facility: Research Site
city: Gdynia
country: Poland
facility: Research Site
city: Krakow
country: Poland
facility: Research Site
city: Lublin
country: Poland
facility: Research Site
city: Toru
country: Poland
facility: Research Site
city: Warszawa
country: Poland
facility: Research Site
city: Brastislava
country: Slovakia
facility: Research Site
city: Komarno
country: Slovakia
facility: Research Site
city: Liptovsky Hradok
country: Slovakia
facility: Research Site
city: Poprad
country: Slovakia
facility: Research Site
city: Povazska Bystrica
country: Slovakia
facility: Research Site
city: Rimavska Sobota
country: Slovakia
facility: Research Site
city: Ziar nad Hronom
country: Slovakia
facility: Research Site
city: Zilina
country: Slovakia
facility: Research Site
Study officials:
affiliation: AZD1386AstraZeneca R&D Wilmington, USA
name: Richard L Leff, MD
role: STUDY_DIRECTOR
affiliation: AZD1386AstraZeneca R&D Södertälje, Sweden
name: Ola Svensson, MD
role: STUDY_CHAIR
References:
citation: Miller F, Bjornsson M, Svensson O, Karlsten R. Experiences with an adaptive design for a dose-finding study in patients with osteoarthritis. Contemp Clin Trials. 2014 Mar;37(2):189-99. doi: 10.1016/j.cct.2013.12.007. Epub 2014 Jan 3.