A Study to Compare the Safety and Tolerability of Sativex... | NCT00713323

NCT00713323

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Description Module

Label	Type	Description	Intervention Names
Sativex	Experimental	Active treatment	Drug: Sativex®

Name	Type	Description	Arm Group Labels	Other Names
Sativex®	Drug	containing THC (27 mg/ml):CBD (25 mg/ml), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavouring. Maximum permitted dose was eight actuations in any three hour period and 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change From Parent Study Baseline in Mean Pain 0-10 Numerical Rating Scale (NRS) Score During the Last 4 Weeks of Open-label Treatment	The average pain NRS was complete at the same time each day, i.e. bedtime in the evening. The patient was asked "on a scale of '0 to 10', please indicate the number that best describes your pain or average pain in the last 24 hours" where 0 = no pain and 10 = pain as bad as you can imagine. No pain relates to the time prior to the onset of pain. A negative value indicates an improvement in pain score from baseline.	38 weeks

Secondary Outcomes

Measure	Description	Time Frame
Change From Parent Study Baseline in Mean Neuropathic Pain Scale (NPS) Score at End of Open-label Treatment (Week 38)	The NPS score is 0-100 sum of 10 individual pain scores (0-10 NRS, 0= no pain to 10 = most pain imaginable). A negative change from baseline indicates an improvement in pain.	38 weeks
Change From Parent Study Baseline in Mean Sleep Quality 0-10 NRS Score at the End of Open-label Treatment (Week 38)

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Had participated in a GW clinical study to investigate the effects of Sativex® on peripheral neuropathic pain and had completed the study. This must have been within the last seven days
Had complied with all of the study requirements in the preceding GW parent RCTs, including the completion of diary cards and study questionnaires
Had shown tolerability to the study medication in a preceding GW study
Was expected, in the opinion of the investigator, to gain clinical benefit from receiving Sativex® therapy
Ability (in the investigators opinion) and willingness to comply with all study requirements, including the completion of diary cards and study questionnaires
Agreement for the responsible authorities (as applicable in individual countries), their primary care physician, and their consultant, if appropriate, to be notified of their participation in the study.

Exclusion Criteria:

History of schizophrenia, other psychotic illness, severe personality disorder or other significant psychiatric disorder other than depression associated with their underlying condition
Known or suspected history of alcohol or substance abuse
History of epilepsy or recurrent seizures
Known or suspected hypersensitivity to cannabinoids or any of the excipients of the study medication Evidence of cardiomyopathy
Experienced myocardial infarction or clinically relevant cardiac dysfunction within the last 12 months or had a cardiac disorder that, in the opinion of the investigator would put the subject at risk of a clinically relevant arrhythmia or myocardial infarction
QT interval; of > 450 ms (males) or > 470 ms (females) at Visit 1
Secondary or tertiary AV block or sinus bradycardia (HR <50bpm unless physiological) or sinus tachycardia (HR>110bpm) at Visit 1
Diastolic blood pressure of <50 mmHg or >105 mmHg in a sitting position at rest for five minutes prior to measurement at Visit 1
Impaired renal function i.e., creatinine clearance is lower than 50ml/min at Visit 1 and is indicative of renal impairment
Significantly impaired hepatic function, at Visit 1, in the Investigator's opinion
Female subjects of child bearing potential and male subjects whose partner was of child bearing potential, unless they were willing to ensure that they or their partner used effective contraception during the study and for three months thereafter
If female, were pregnant or lactating, or were planning pregnancy during the course of the study and for three months thereafter
Received an IMP within the 12 weeks before Visit 1 (except the prerequisite study medication from the GW parent RCTs)
Any other significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, may influence the result of the study or the subject's ability to participate in the study
Following a physical examination, the subject had any abnormalities that, in the opinion of the investigator, would prevent the subject from safely participating in the study.
Intention to donate blood during the study
Previous randomisation into this study

Name	Affiliation	Role
Barbara Hoggart, MBBS, FRCA	Pain Management Research, Clinical Trials Unit, Netherwood House, Solihull Hospital	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Pain Management Research, Clinical Trials Unit, Netherwood House, Solihull Hospital		Solihull	West Midlands	B91 2JL,	United Kingdom

ID	Title	Description
FG000	Sativex	Subjects received Sativex delivered in 100 μl actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations in 24 hours (THC 65 mg:CBD 60 mg).

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Sativex	Subjects received Sativex delivered in 100 μl actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations in 24 hours (THC 65 mg:CBD 60 mg).

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Categorical			Count of Participants

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Change From Parent Study Baseline in Mean Pain 0-10 Numerical Rating Scale (NRS) Score During the Last 4 Weeks of Open-label Treatment

The average pain NRS was complete at the same time each day, i.e. bedtime in the evening. The patient was asked "on a scale of '0 to 10', please indicate the number that best describes your pain or average pain in the last 24 hours" where 0 = no pain and 10 = pain as bad as you can imagine. No pain relates to the time prior to the onset of pain. A negative value indicates an improvement in pain score from baseline.

All subjects who received at least one dose of open-label Sativex were included in the analysis.

Posted

Mean

Standard Deviation

units on a scale

38 weeks

ID	Title	Description
OG000	Sativex	Subjects received Sativex delivered in 100 μl actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations in 24 hours (THC 65 mg:CBD 60 mg).

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Sativex	Subjects received Sativex delivered in 100 μl actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations in 24 hours (THC 65 mg:CBD 60 mg).

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
IDIOPATHIC THROMBOCYTOPENIC PURPURA	Blood and lymphatic system disorders	MedDRA 8.1	Systematic Assessment

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D009468	Neuromuscular Diseases

ID	Term
D010146	Pain
D010523	Peripheral Nervous System Diseases