Chronic pain
Conditions
Interventions
In this randomized, double blind, active-comparator and crossover study, subjects were randomized to receive one oxycodone 20 mg (Oxynorm Instant, Mundipharma BV, Hoevelaken, The Netherlands) orodispe
the subject was not allowed to swallow until the drug had completely disintegrated. To assess the analgesic treatment efficacy, two nociceptive assays were applied: electrical noxious stimulation of t
Sponsors
None listed
Eligibility
Inclusion criteria
Inclusion criteria: Healthy male or female volunteer age 18 - 65 years, body mass index 18 - 35 kg/m2 body weight 50 - 100 kg.
Exclusion criteria
Exclusion criteria: (a) a history of mental health problems; (b) a history of alcohol or substance abuse; (c) alcohol use of three or more (male) or two or more (female) units per day; (d) positive pregnancy test; (e) females not using oral contraceptives, not surgically sterilized, or not post-menopausal (last menstrual period > 2 years ago and FSH > 25 IU/L); (f) a history of allergic or anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food, (g) participation in an investigational drug trial in the last 3 months or participation in medical trials more than 4 times per year; and (h) any other condition that in the opinion of the investigator would complicate or compromise the study, or the well-being of the subject.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain relief as measured by electrical pain tolerance, electrical pain threshold and pressure pain threshold. | — |
Contacts
Public ContactAlbert Dahan
Leiden University Medical Center (LUMC), Department of Anesthesiology, P.O. Box 9600
Outcome results
None listed