NCT00750347

Brief Summary

Evaluation of an possible inhibiting effect of Rimonabant on the analgesic effect of Paracetamol in healthy volunteers

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at P25-P50 for phase_1 pain

Timeline
Completed

Started Sep 2008

Shorter than P25 for phase_1 pain

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

September 9, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 10, 2008

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
Last Updated

January 19, 2011

Status Verified

January 1, 2011

Enrollment Period

1 month

First QC Date

September 9, 2008

Last Update Submit

January 18, 2011

Conditions

Pain

Keywords

pain,analgesiaHealthy volunteers

Outcome Measures

Primary Outcomes (1)

  • Pain's threshold with electrical stimulation (Pain Matcher). Pain's threshold with mechanical stimulation (electronical Von Frey).

    during electrical stimulation

Secondary Outcomes (1)

  • Plasmatic concentration of paracetamol or his metabolite with or without Rimonabant

    with or without rimonabant

Interventions

Rimonabant and Paracetamol and placeboDRUG

evaluation of an possible inhibiting effect of rimonabant on the analgesic effect of paracetamol in healthy volunteers

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy volunteers
  • between 18 and 40 years old
  • written consent given

You may not qualify if:

  • Rimonabant or paracetamol hypersensibility
  • Excessive consumption of alcohol, tobacco, coffee, tea or toxicomania
  • Concomitant medication
  • Chronical diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CIC-CPC

Clermont-Ferrand, 63000, France

Location

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

MeSH Terms

Conditions

PainAgnosia

Interventions

RimonabantAcetaminophen

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Intervention Hierarchy (Ancestors)

PyrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPiperidinesAcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Dubray Claude, Pr

    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

Study Record Dates

First Submitted

September 9, 2008

First Posted

September 10, 2008

Study Start

September 1, 2008

Primary Completion

October 1, 2008

Study Completion

October 1, 2008

Last Updated

January 19, 2011

Record last verified: 2011-01

Locations

FR(2)