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

NCT00878501 | Terminated Phase 2 Results

• 1 other identifier: D5090C00019
• Study Type: interventional
• Target: 241
• Locations: 7 countries
• Sites: 41

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.

Conditions

Pain

Keywords

Phase II; Pain

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (3)

• Mean of Week 2 and Week 4 Changes From Baseline in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Function Subscale, 48 Hours Recall.

  Baseline, Week 2 and Week 4.

• Mean of Week 2 and Week 4 Changes From Baseline in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Stiffness Subscale, 48 Hours Recall.

  Baseline, Week 2 and Week 4.

• Mean of Week 2 and Week 4 Changes From Baseline in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Total Score, 48 Hours Recall

  Baseline, Week 2 and Week 4.

Study Arms (3)

AZD1386, 90 mg

EXPERIMENTAL

Drug: AZD1386

AZD1386, 30 mg

EXPERIMENTAL

Drug: AZD1386

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

AZD1386 DRUG

oral, during 4 weeks

AZD1386, 90 mg

Placebo DRUG

Oral, during 4 weeks

Placebo

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with OA of the knee
• Male or non pregnant females 40 and 80 years old

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (41)

Research Site

Pleven, Bulgaria

Location

Research Site

Sofia, Bulgaria

Location

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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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Research Site

Žilina, Slovakia

Location

Related Publications (1)

• 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.

  PMID: 24394343 DERIVED

MeSH Terms

Conditions

Pain

Interventions

AZD1386

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Gerard Lynch
• Organization: AstraZeneca

aztrial_results_posting@astrazeneca.com

Study Officials

• Richard L Leff, MD

  AZD1386AstraZeneca R&D Wilmington, USA

  STUDY DIRECTOR

• Ola Svensson, MD

  AZD1386AstraZeneca R&D Södertälje, Sweden

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2009
• First Posted: April 9, 2009
• Study Start: March 1, 2009
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: June 4, 2012
• Results First Posted: May 28, 2012

Record last verified: 2012-05

Locations

SL (8); BU (2); CA (11); HU (6); JP (1); PL (7); FI (6)