A randomised, double-blind, placebo-controlled, parallel group study to investigate the safety and efficacy of controlled-releas
Thursday, October 25, 2007

*

No Authors Listed- GlaxoSmithKline corporate document

This was a proof of concept study, to evaluate the safety and efficacy of ropinirole CR in subjects with fibromyalgia syndrome (FMS).  The objective was To evaluate the analgesic efficacy of oral ropinirole controlled release formulation (CR) compared to placebo over a dose range in adult subjects with FMS as measured by the 11-point Pain Intensity Numerical Rating Scale (PI-NRS).  A total of 22 centres screened and recruited at least one subject in the following countries: Belgium, Denmark, Finland, France, Germany, Italy, Sweden, The Netherlands and the United Kingdom.  Study medication was provided as: ropinirole CR tablets of 1.0mg, 2.0mg, 4.0mg and 8.0mg, and matching placebo tablets. All tablets were white aqueous film coated capsule shaped tablets, with 'SB' embossed on both sides. Subjects were randomised (1:1) to receive once daily doses of ropinirole CR or placebo tablets according to the dose titration regimen […] until an optimal therapeutic dose was achieved based on efficacy and tolerability as judged by the investigator.  No statistically significant differences between placebo and ropinirole CR were observed for the primary efficacy endpoint or the key secondary efficacy endpoints. In the placebo group 73 subjects (80%) reported non-serious adverse events with the most frequently reported being nausea, dizziness and headache. In the ropinirole CR group 82 subjects (91%) reported non-serious adverse events with the most frequently reported being nausea, dizziness and headache. One subject in the placebo group reported the non-fatal SAE of anaemia. Two subjects in the ropinirole CR group reported a single non-fatal SAE: one subject reported the SAE of unstable angina and one subject reported abdominal pain upper. No fatalities were reported during the study.