drugset / Trial / NCT00893412

Fast-Release Orodispersible Tramadol Tablet (Tradonal Odis®) as Analgesia for Hysterosalpingography

NCT00893412

Phase 4 Completed 128 enrolled University Hospital Brussels
RandomizedParallel-groupTriple-blindTreatment

Summary

This study evaluates the analgetic effects of the fast-release orodispersible tramadol tablet. Tramadol acts through a weak affinity for μ receptors and secondly by inhibiting noradrenaline and serotonin neuronal reuptake. It has been used since the 1970s by over 50 million people for the treatment of acute and chronic pain. The orodispersible Tramadol tablet is a new galenic form and is available on the Belgian market for the last three years. Pregastric absorption leads to a quicker onset of action. So far, evidence shows that pain during and immediately after the Hysterosalpingography (HSG) procedure is only significantly reduced by IV opioid analgesia. This study evaluates the analgetic potential of an orodispersible opioid tablet. This tablet disintegrates rapidly (in around 20-30 seconds) and may be taken without water. Its abuse potential is very low and its respiratory depressant effect is negligible.

Timeline

Start
2008-11
Primary completion
2009-04
Completion
2009-04

Drugs

EvaluationDrugModalityDoseRoute
Comparator Tramadol Other / unclassified 50 mg Oral

Indications