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Study to Investigate the Effects Single Oral Dose of AZD1386 (Capsaicin)

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ClinicalTrials.gov Identifier: NCT00692146
Recruitment Status : Completed
First Posted : June 6, 2008
Last Update Posted : June 6, 2008
Sponsor:
Information provided by:
AstraZeneca

Brief Summary:
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 or disease Intervention/treatment Phase
Capsaicin Evoked Pain Heat Sensitivity Drug: AZD1386 Drug: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : January 2008
Primary Completion Date : May 2008
Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy
Drug Information available for: Capsaicin
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
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)
Placebo Comparator: 2
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)



Primary Outcome Measures :
  1. VAS, HPT [ Time Frame: Visit 2-4 ]

Secondary Outcome Measures :
  1. eVAS, HPT, Laser Doppler imaging,WDT, Somedic allodynia [ Time Frame: Visit 2-4 ]
  2. 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 ]
  3. Pharmacokinetics/Pharmacodynamics [ Time Frame: Visit 2-4 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Rolf Karlsten, MD, PhD Medical Science Director, AstraZeneca R&D Södertälje
ClinicalTrials.gov Identifier: NCT00692146     History of Changes
Other Study ID Numbers: D5090C00009
First Posted: June 6, 2008    Key Record Dates
Last Update Posted: June 6, 2008
Last Verified: June 2008

Keywords provided by AstraZeneca:
Proof of Mechanism
Capsaicin evoked pain

Additional relevant MeSH terms:
Hypersensitivity
Immune System Diseases
Capsaicin
Antipruritics
Dermatologic Agents
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs