Status:
COMPLETED
A Study to Determine the Maintenance of Effect After Long-term Treatment of Sativex® in Subjects With Neuropathic Pain
Lead Sponsor:
Jazz Pharmaceuticals
Conditions:
Pain
Peripheral Neuropathy
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to assess the maintenance of effect after long-term treatment of Sativex® in subjects with neuropathic pain.
Detailed Description
A five week randomised-withdrawal phase (Part B) for a subset of subjects who took part in a 38 week, multicentre, open label (Part A) follow-on study to evaluate, the maintenance of effect of, the de...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2007
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT00713817
Start Date
March 1 2007
End Date
July 1 2007
Last Update
May 3 2023
Active Locations (1)
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1
Pain Management Research, Clinical Trials Unit, Netherwood House, Solihull Hospital
Solihull, West Midlands, United Kingdom, B91 2JL,