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

NCT ID: NCT00878501

Last Updated: 2012-06-04

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

241 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2009-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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AZD1386, 90 mg

Group Type EXPERIMENTAL

AZD1386

Intervention Type DRUG

oral, during 4 weeks

AZD1386, 30 mg

Group Type EXPERIMENTAL

AZD1386

Intervention Type DRUG

oral, during 4 weeks

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Oral, during 4 weeks

Interventions

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AZD1386

oral, during 4 weeks

Intervention Type DRUG

AZD1386

oral, during 4 weeks

Intervention Type DRUG

Placebo

Oral, during 4 weeks

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Richard L Leff, MD

Role: STUDY_DIRECTOR

AZD1386AstraZeneca R&D Wilmington, USA

Ola Svensson, MD

Role: STUDY_CHAIR

AZD1386AstraZeneca R&D Södertälje, Sweden

Locations

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Research Site

Pleven, , Bulgaria

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Sofia, , Bulgaria

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Bay Roberts, Newfoundland and Labrador, Canada

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St. John's, Newfoundland and Labrador, Canada

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Halifax, Nova Scotia, Canada

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Brampton, Ontario, Canada

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Etobicoke, Ontario, Canada

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Hamilton, Ontario, Canada

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Newmarket, Ontario, Canada

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St. Catharines, Ontario, Canada

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Charlottetown, Prince Edward Island, Canada

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Saint Romuald, Quebec, Canada

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Sherbrooke, Quebec, Canada

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Helsinki, , Finland

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Hyvinkää, , Finland

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Lahti, , Finland

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Riihimäki, , Finland

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Tampere, , Finland

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Vantaa, , Finland

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Békéscsaba, , Hungary

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Budapest, , Hungary

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Debrecen, , Hungary

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Miskolc, , Hungary

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Nyíregyháza, , Hungary

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Veszprém, , Hungary

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Japan, , Japan

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Bialystok, , Poland

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Elblag, , Poland

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Gdynia, , Poland

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Krakow, , Poland

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Lublin, , Poland

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Toru, , Poland

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Warsaw, , Poland

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Brastislava, , Slovakia

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Komárno, , Slovakia

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Liptovský Hrádok, , Slovakia

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Poprad, , Slovakia

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Považská Bystrica, , Slovakia

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Rimavská Sobota, , Slovakia

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Žiar nad Hronom, , Slovakia

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Žilina, , Slovakia

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Countries

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Bulgaria Canada Finland Hungary Japan Poland Slovakia

References

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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.

Reference Type DERIVED
PMID: 24394343 (View on PubMed)

Other Identifiers

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D5090C00019

Identifier Type: -

Identifier Source: org_study_id

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