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

AstraZeneca

Status and phase: Terminated; Phase 2

Conditions: Pain

Treatments: Drug: AZD1386; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00878501

D5090C00019

Details and patient eligibility

About

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.

Enrollment: 241 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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241 participants in 3 patient groups, including a placebo group

AZD1386, 90 mg

Experimental group

Treatment:

Drug: AZD1386

Drug: AZD1386

AZD1386, 30 mg

Experimental group

Treatment:

Drug: AZD1386

Drug: AZD1386

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo