NCT01390467

Brief Summary

Randomized study, double-blind, crossover, controlled versus placebo.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Jul 2011

Typical duration for phase_1 healthy

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

July 7, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 11, 2011

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

January 30, 2012

Status Verified

January 1, 2012

Enrollment Period

Same day

First QC Date

July 7, 2011

Last Update Submit

January 26, 2012

Conditions

Healthy

Keywords

ParacetamolCognitive impact

Outcome Measures

Primary Outcomes (1)

  • Assess cognitive impact of taking paracetamol within healthy volunteers by comparing the results on cognitive tests Cantab® between two passages, in particular a memory test (SOC)

    after the results on cognitive tests Cantab

Secondary Outcomes (1)

  • Assess cognitive impact of taking paracetamol on other cognitive tests Cantab® (understanding : MOT and DMS, reaction time : RTI, visual memory : PRM, decision making : IST)

    after an other cognitive test Cantab

Interventions

Cantab®DRUG

Randomized study, double-blind, crossover, controlled versus placebo.

Eligibility Criteria

Age18 Years - 25 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy volunteers,
  • aged over 18 years and not more than 25 years,
  • males,

You may not qualify if:

  • Contraindications to the administration of paracetamol
  • medical and/or surgical history judged by the investigator or his representative as being incompatible with the test, especially subjects with neuropathic pain
  • excessive intake of alcohol, tobacco (more than 10 cigarettes / day), coffee, tea or drinks containing caffeine (equivalent to more than 4 cups per day) or drug

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Neuropsychological Tests

Intervention Hierarchy (Ancestors)

Psychological TestsBehavioral Disciplines and Activities

Study Officials

  • Gisèle PICKERING

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 7, 2011

First Posted

July 11, 2011

Study Start

July 1, 2011

Primary Completion

July 1, 2011

Study Completion

January 1, 2012

Last Updated

January 30, 2012

Record last verified: 2012-01