Text Size

Dose Response and Efficacy of GW842166 in Pain

This study has been terminated.
(cancelled before enrollment)
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00554762
First received: November 5, 2007
Last updated: June 12, 2008
Last verified: June 2008
History of Changes
  Purpose

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 Intervention Phase
Healthy Volunteers
 Drug: GW842166X
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
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.

Further study details as provided by GlaxoSmithKline:

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

Secondary Outcome Measures:
  • • 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 ]

Enrollment: 0
Study Start Date: November 2007
Estimated Study Completion Date: March 2008
Estimated Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00554762

Locations
United Kingdom
GSK Clinical Clinical Trials Call Center
Cambridge, United Kingdom, CB2 2GG
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, MRCP, FFPM GlaxoSmithKline
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00554762     History of Changes
Other Study ID Numbers: CBA110877
Study First Received: November 5, 2007
Last Updated: June 12, 2008
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

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

ClinicalTrials.gov processed this record on May 16, 2013