Last updated: 11/04/2018 05:52:33
Dose Response and Efficacy of GW842166 in Pain
GSK study ID
CBA110877
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Withdrawn
Withdrawn
Trial overview
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.
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
• Heat pain threshold at 5 hours post dose
Timeframe: 5 Hours
Secondary outcomes:
• Heat pain threshold at 3 hours post dose. • Mechanical pain threshold (using von Frey filaments) at 3 and 5 hours post dose.
Timeframe: 5 Hours
Interventions:
Drug: GW842166X
Enrollment:
0
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Healthy Subjects
Product
GW842166
Collaborators
Not applicable
Study date(s)
January 2008 to March 2008
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18 - 50 years
Accepts healthy volunteers
Yes
- 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.
- 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.
Inclusion and exclusion 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.
Trial location(s)
No location data available.
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Withdrawn
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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