Study to Investigate the Effects Single Oral Dose of AZD1386 (Capsaicin) - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00692146

Purpose

A double-blind, randomized, single-centre, placebo-controlled, crossover study to investigate the effects of a single oral dose of AZD1386 on intradermal capsaicin evoked pain symptoms and heat sensitivity in healthy volunteers

Condition	Intervention	Phase
Capsaicin Evoked Pain Heat Sensitivity	Drug: AZD1386 Drug: Placebo	Phase I

Drug Information available for: Capsaicin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Crossover Assignment, Pharmacokinetics/Dynamics Study
Official Title:	A Double-Blind, Randomized, Single-Centre, Placebo-Controlled, Crossover Study to Investigate the Effects of a Single Oral Dose of AZD1386 on Intradermal Capsaicin Evoked Pain Symptoms and Heat Sensitivity in Healthy Volunteers

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

VAS, HPT [ Time Frame: Visit 2-4 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

eVAS, HPT, Laser Doppler imaging,WDT, Somedic allodynia [ Time Frame: Visit 2-4 ] [ Designated as safety issue: No ]
Vital signs, laboratory variables and adverse event each day throughout the study. paper printout ECG and/or digital ECG throughout the study. Pain evoked assessments visit 1-3 [ Time Frame: Visit 1-5 ] [ Designated as safety issue: Yes ]
Pharmacokinetics/Pharmacodynamics [ Time Frame: Visit 2-4 ] [ Designated as safety issue: No ]

Enrollment:	36
Study Start Date:	January 2008
Study Completion Date:	May 2008
Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 36 subjects receiving a specified volume of the active component AZD1386 in a single dose.	Drug: AZD1386 Oral solution fixed dose (95 mg given orally on two occasions)
2: Placebo Comparator 36 subjects receiving a specified volume of placebo in a single dose.	Drug: Placebo Oral solution fixed dose (95 mg given orally on two occasions)

Eligibility

Ages Eligible for Study:	20 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Clinical normal physical findings, including BP, pulse rate >45 bpm, ECG and laboratory assessments
Body Mass Index (BMI) of ≥18 to ≤30 kg/m2 and weight of ≥50 to ≤100 kg.
Non-fertile females

Exclusion Criteria:

History of hypersensitivity, allergy or atopic/skin disease as judged by Investigator.
History of somatic or psychiatric disease/condition, which may interfere with the objectives of the study as judged by the Investigator.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00692146

Sponsors and Collaborators

AstraZeneca

Investigators

Study Chair:	Agneta Berg	AstraZeneca R&D Södertälje
Principal Investigator:	Ingemar Bylesjö	AstraZeneca R&D CPU Karolinska University Hospital, Stockholm

More Information

Responsible Party:	AstraZeneca R&D Södertälje ( Rolf Karlsten, MD, PhD Medical Science Director )
Study ID Numbers:	D5090C00009
Study First Received:	June 5, 2008
Last Updated:	June 5, 2008
ClinicalTrials.gov Identifier:	NCT00692146
Health Authority:	Sweden: Medical Products Agency; Sweden: Regional Ethical Review Board

Keywords provided by AstraZeneca:

Proof of Mechanism
Capsaicin evoked pain

Study placed in the following topic categories:

Pain
Healthy
Capsaicin

Additional relevant MeSH terms:

Sensory System Agents
Therapeutic Uses
Physiological Effects of Drugs
Antipruritics

Peripheral Nervous System Agents
Dermatologic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009