AZD2066 Neuropathic Pain - Mechanical Hypersensitivity - Full Text View

Sponsors and Collaborators:	AstraZeneca Quintiles
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00939094

Purpose

The purpose of this study is to investigate if 28 days of treatment with AZD2066 compared to placebo can relieve the pain arising from the nervous system when the patients are touched by something that should not cause pain or have severe pain when they are touched by something that should only cause a little pain.

Condition	Intervention	Phase
Neuropathic Pain Mechanical Hypersensitivity	Drug: AZD2066 Drug: Placebo	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study
Official Title:	A Phase IIa, Double-Blind, Randomised, Parallel-Group, Multi-Centre Study to Evaluate the Analgesic Efficacy of 28 Days Oral Administration of AZD2066 Compared to Placebo in Peripheral Neuropathic Pain Patients With Mechanical Hypersensitivity

Resource links provided by NLM:

MedlinePlus related topics: Allergy

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

To evaluate the analgesic efficacy of 28 days of oral administration of AZD2066 compared to placebo in peripheral neuropathic pain patients with mechanical hypersensitivity (NP-MH). Pain intensity assessed by NRS score twice daily. [ Time Frame: Twice daily for 28 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To evaluate the response rate of patients to AZD2066 versus placebo, assessed as improvement of NRS of at least 30 and 50% respectively, and as PGIC of at least "much improved". [ Time Frame: NRS twice daily and PGIC every visit (approximately weekly). ] [ Designated as safety issue: No ]
To evaluate the effect of AZD2066 on different components of pain compared to placebo, assessed as change from baseline in BPI-SF and SF-MPQ. [ Time Frame: Throughout the study. ] [ Designated as safety issue: No ]
To evaluate safety and tolerability of AZD2066. [ Time Frame: Throughout the study. ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	August 2009
Estimated Study Completion Date:	April 2010
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	Drug: AZD2066 Capsule, once daily
B: Placebo Comparator	Drug: Placebo Capsule, once daily

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Provision of informed consent prior to any study specific procedures.
Male or non-fertile females
Painful symptoms due to neuropathic pain for a period of 3 months to 5 years, associated with mechanical allodynia and/or punctate hyperalgesia.

Exclusion Criteria:

Other pain that may confound assessment of neuropathic pain.
Diagnosis of any severe neurological disease.
History of significant psychiatric disease/condition and/or history of psychotic disorders among first degree relatives.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00939094

Contacts

Contact: Quintiles Worldwide

clinical.studies.ns@quintiles.com

Show 26 Study Locations

Sponsors and Collaborators

AstraZeneca

Quintiles

Investigators

Study Director:	Biljana Lilja	AstraZeneca R&D Södertälje151 85 Södertälje, Sweden
Principal Investigator:	Brett Stacey	Oregon Health and Science University Comprehensive Pain Clinic, Portland, OR 97239, USA

More Information

No publications provided

Responsible Party:	AstraZeneca ( MSD )
Study ID Numbers:	D0475C00016
Study First Received:	July 13, 2009
Last Updated:	August 24, 2009
ClinicalTrials.gov Identifier:	NCT00939094 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

Pain, Mechanical Hypersensitivity
Allodynia
Efficacy
analgesia
Neuropathic

Study placed in the following topic categories:

Hypersensitivity
Pain
Analgesics

Additional relevant MeSH terms:

Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on September 11, 2009