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Dose Response and Efficacy of GW842166 in Pain

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ClinicalTrials.gov Identifier: NCT00554762
Recruitment Status : Withdrawn (Compound terminated)
First Posted : November 7, 2007
Last Update Posted : February 16, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to assess the dose response and efficacy of single and repeat doses of GW842166 in healthy volunteers using pharmacodynamic pain assessments.

Condition or disease Intervention/treatment Phase
Healthy Subjects Drug: GW842166X Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase I, Placebo Controlled, Randomised, Double Blind Two-way Crossover Study to Investigate the Dose Response and Efficacy of Single and Repeat Doses of GW842166 in Healthy Volunteers Using Pharmacodynamic Pain Assessments.
Study Start Date : November 2007
Estimated Primary Completion Date : March 2008
Estimated Study Completion Date : March 2008
Arms and Interventions

Intervention Details:
    Drug: GW842166X
    Administer

Outcome Measures

Primary Outcome Measures :
  1. • Heat pain threshold at 5 hours post dose [ Time Frame: 5 Hours ]

Secondary Outcome Measures :
  1. • Heat pain threshold at 3 hours post dose. • Mechanical pain threshold (using von Frey filaments) at 3 and 5 hours post dose. [ Time Frame: 5 Hours ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male or female subjects aged 18 to 50 years inclusive
  • Body Weight >50 Kg and BMI within the range 18.5 to 32 kg/m2 inclusive.
  • Women who are not of child bearing potential

Exclusion Criteria:

  • The subject has a positive pre-study urine screen for drugs of abuse or positive alcohol test.
  • A positive pre-study (HIV), hepatitis B surface antigen or positive hepatitis C antibody result within 3 months of the start of the study.
  • Abuse of alcohol defined as an average weekly intake of greater than 28 units (21 units for women) or an average daily intake of greater than 3 units (2 units for women). 1 unit is equivalent to a half-pint (220 mL) of beer or 1 (25 mL) measure of spirits or 1 glass (125 mL) of wine.
  • Where participation in study would result in donation of blood in excess of 500 mL within a 56 day period.
Contacts and Locations

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): NCT00554762


Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
More Information

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00554762     History of Changes
Other Study ID Numbers: CBA110877
First Posted: November 7, 2007    Key Record Dates
Last Update Posted: February 16, 2015
Last Verified: February 2015

Keywords provided by GlaxoSmithKline:
mechanical pain,
heat pain,
dose,
efficacy
dose response,
GW842166,
Single,
pharmacodynamics,
repeat dose,