Primary Outcome Measures:
- The mean daily peripheral neuropathic pain on a 0-10 NRS score during the last seven days of treatment (end of treatment) [ Time Frame: Day 0 to Day 98 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Neuropathic Pain Score [ Time Frame: Day 0 to Day 98 ] [ Designated as safety issue: No ]
- sleep quality 0-10 NRS [ Time Frame: Day 7 to Day 98 ] [ Designated as safety issue: No ]
- dynamic allodynia test [ Time Frame: Day 7 and Day 98 ] [ Designated as safety issue: No ]
- punctate allodynia test [ Time Frame: Day 7 and Day 98 ] [ Designated as safety issue: No ]
- subject global impression of change [ Time Frame: Day 7 and Day 98 ] [ Designated as safety issue: No ]
- brief pain inventory (Short form) [ Time Frame: Day 7 and Day 98 ] [ Designated as safety issue: No ]
- quality of life EuroQol 5-D [ Time Frame: Day 7 and Day 98 ] [ Designated as safety issue: No ]
- use of rescue analgesia [ Time Frame: Day 0- Day 98 ] [ Designated as safety issue: No ]
- Adverse events [ Time Frame: Day 0 - Day 98 ] [ Designated as safety issue: Yes ]
- Clinical laboratory tests [ Time Frame: Day 0 and Day 98 ] [ Designated as safety issue: Yes ]
- Vital signs [ Time Frame: Day 0 - Day 98 ] [ Designated as safety issue: No ]
- Oral Examination. [ Time Frame: Day 0 and Day 98 ] [ Designated as safety issue: Yes ]
- intoxication 0-10 NRS [ Time Frame: Day 0 - Day 98 ] [ Designated as safety issue: Yes ]
This was a 15 week (one week baseline and fourteen weeks treatment period), multicentre, double blind, randomised, placebo controlled, parallel group study to evaluate the efficacy of Sativex® in subjects with PNP, associated with allodynia. Subjects were screened to determine eligibility and completed a seven-day baseline period. Subjects then returned to the centre for assessment, randomisation and dose introduction. Visits occurred at the end of weeks two, six, ten and at the end of the study (treatment week 14) or earlier if they withdrew. A follow up visit occurred 28 days after completion or withdrawal. Subjects in this study were given the opportunity to be enrolled in an open label extension study.