Clinical trial NCT00713817: A Study to Determine the Maintenance of Effect After Long-term Treatment of Sativex® in Subjects With Neuropathic Pain
Official title: A Multicentre, Open Label, Follow on Study to Assess the Maintenance of Effect, Tolerance and Safety of Sativex® in the Treatment of Subjects With Neuropathic Pain. This Will be Followed by a Randomised-withdrawal Phase (Part B) for a Subset of Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain
Peripheral Neuropathy
Keywords: Pain
Peripheral Neuropathy
Lead sponsor: Jazz Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2008-07-11
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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 development of tolerance through exposure to, and safety of, Sativex® in the treatment of subjects with neuropathic pain. Subjects returned to the centre for an end of treatment visit at week 38 of Part A (Visit 5, Day 266), followed by Visits 5b (week 39), 5c (week 43) and an end of study visit took place 28 days after Visit 5c or withdrawal from the study.

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

Primary outcomes:
measure: 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)
timeFrame: Day 0-35
Secondary outcomes:
measure: Change From Baseline Neuropathic Pain Score at the End of Treatment
timeFrame: Day 7 to 35
measure: Number of Subjects Who Failed Treatment at the End of the Treatment Period
timeFrame: Day 7 to time of last dose
measure: Number of Subjects With More Than a 20% Loss of Response at the End of Treatment
timeFrame: Day 0-35
measure: Change From Baseline in Sleep Disruption 0-10 Numerical Rating Scale Score at the End of Treatment (Average of Last 7 Days Treatment)
timeFrame: Day 0-35
measure: Subject Global Impression of Change at the End of Treatment
timeFrame: Day 7 to 35
measure: Incidence of Adverse Events as a Measure of Subject Safety
timeFrame: Day 0 -35
Other outcomes:
Locations:
city: Solihull
country: United Kingdom
facility: Pain Management Research, Clinical Trials Unit, Netherwood House, Solihull Hospital
state: West Midlands
Study officials:
affiliation: Pain Management Research, Clinical Trials Unit, Netherwood House, Solihull Hospital
name: Barbara Hoggart, MBBS, FRCA
role: PRINCIPAL_INVESTIGATOR
References: