Peri-operative pain peri-operative pain
Conditions
Interventions
Subjects will receive a 3 cm diameter round disc soaked in 3% and 10% MO (400
µL) on the inner forearms in two separate sessions within one day.
Subjects will also inhale 2 mL of a nebulized (turne
the strength of the CMDH solution will be 200 mM in the morning
session and 350 mM in the afternoon session. The number of coughs induced by
the inhalation will be recorded during the subsequent 15
Sponsors
PRA International EDS
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: healthy male subjects 18-45 yrs, inclusive BMI: 18.0-30.0 kg/m2, inclusive non-smoking
Exclusion criteria
Exclusion criteria: Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 90 days before the start of this study or being a blood donor within 60 days from the start of the study. In case of donating more than 1.5 liters of blood in the 10 months prior the start of this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MO challenge: size of the area of brush allodynia; pain intensity (NRS), cutaneous Doppler blood flow, area of flare response; CMDH challenge: counting the number of coughs induced within 15 seconds after CMDH inhalation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety: Adverse events (AE's). | — |
Countries
Netherlands
Outcome results
None listed