Phase 3 Completed N=19 Randomized Quadruple-blind Supportive Care

A Study to Determine the Maintenance of Effect After Long-term Treatment of Sativex® in Subjects With Neuropathic Pain

Postoperative Pain · peripheral neuropathy

Source: ClinicalTrials.gov NCT00713817 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2012

Primary outcomePrimary: Change From Baseline in Mean Daily Pain Severity on a 0-10 Numerical Rating Scale Score at the End of Treatment (Average of Last 7 Days Treatment) — 0.57; -0.49 units on a scale — p=0.273

Summary

The purpose of this study is to assess the maintenance of effect after long-term treatment of Sativex® in subjects with neuropathic pain.

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in Mean Daily Pain Severity on a 0-10 Numerical Rating Scale Score at the End of Treatment (Average of Last 7 Days Treatment)	0.57; -0.49	0.273
SECONDARY Change From Baseline Neuropathic Pain Score at the End of Treatment	2.56; -2.06	0.296
SECONDARY Number of Subjects Who Failed Treatment at the End of the Treatment Period	5; 4	0.826
SECONDARY Number of Subjects With More Than a 20% Loss of Response at the End of Treatment	3; 2	0.54
SECONDARY Change From Baseline in Sleep Disruption 0-10 Numerical Rating Scale Score at the End of Treatment (Average of Last 7 Days Treatment)	0.24; 0.12	0.902
SECONDARY Subject Global Impression of Change at the End of Treatment	5; 4	0.603
SECONDARY Incidence of Adverse Events as a Measure of Subject Safety	3; 2	—

Eligibility Criteria

Inclusion Criteria

Had participated in GWCL0404, was currently ongoing in the study (i.e. still receiving GW-1000-02 treatment) and had completed the study up to Visit 5
Had complied with all of the study requirements to-date, including the completion of the diary cards
Had shown tolerability to the study medication in this study
Ability (in the investigators opinion) and willingness to comply with all study requirements, including the completion of diary cards and study questionnaires

Exclusion Criteria

Had experienced or was currently experiencing any adverse events or untoward medical occurrences which, in the opinion of the investigator, would prevent them from safely participating in this phase of the study

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00713817). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.