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A Multicenter, Non-comparative, Open-label Extension Study to Assess the Long Term Safety of Sativex® Oromucosal Spray (Nabiximols) as Adjunctive Therapy in Patients With Uncontrolled Persistent Chronic Cancer-related Pain


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Pain, Advanced Cancer

Thank you

Trial Information

A Multicenter, Non-comparative, Open-label Extension Study to Assess the Long Term Safety of Sativex® Oromucosal Spray (Nabiximols) as Adjunctive Therapy in Patients With Uncontrolled Persistent Chronic Cancer-related Pain


Inclusion Criteria:



- Patient has completed the parent study within the last seven days

- Willing and able to give written informed consent

- Willing and able to comply with all study requirements

Exclusion Criteria:

- The patient is currently using cannabis or cannabinoid based medications, other than
the parent study IMP, and is unwilling to abstain for the duration of the study

- Any history or immediate family history of schizophrenia, other psychotic illness,
severe personality disorder or other significant psychiatric disorder other than
depression associated with their underlying condition

- Any known or suspected history of a substance abuse/dependence disorder (including
opiate abuse/dependence prior to the diagnosis of cancer)

- Has poorly controlled epilepsy or recurrent seizures (i.e. one or more seizure during
the last year)

- Has experienced myocardial infarction or clinically significant cardiac dysfunction
within the last 12 months or has a cardiac disorder that, in the opinion of the
investigator would put the patient at risk of a clinically significant arrhythmia or
myocardial infarction

- Has significantly impaired renal function

- Has significantly impaired hepatic function

- Female patients of child-bearing potential and male patients whose partner is of
child-bearing potential, unless willing to ensure that they or their partner use
effective contraception, for example, oral contraception, double barrier,
intra-uterine device, during the study and for three months thereafter (however, a
male condom should not be used in conjunction with a female condom as this may not
prove effective)

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Incidence of adverse events (AEs)

Outcome Description:

Incidence of adverse events (AEs) coded according to the MedDRA dictionary. Descriptive presentations of treatment emergent AEs will be given by preferred term and system organ class. The number of patients reporting at least one AE will be provided.

Outcome Time Frame:

6 months

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

GWCA0999

NCT ID:

NCT01337089

Start Date:

January 2011

Completion Date:

August 2014

Related Keywords:

  • Pain
  • Advanced Cancer
  • cancer pain
  • opioid therapy
  • inadequate analgesia
  • optimized chronic opioid therapy
  • Neoplasms

Name

Location

Hinsdale, Illinois  60521
Albany, Georgia  31701
Birmingham, Alabama  35294
Phoenix, Arizona  85012
Fountain Valley, California  92708
Miami, Florida  33176
Columbia, Missouri  65203
Albany, New York  12208
Cleveland, Ohio  44195
Philadelphia, Pennsylvania  19104
Austin, Texas  78705
Seattle, Washington  98195
Hackensack, New Jersey  07601
Metairie, Louisiana  70006
Boston, Massachusetts  
Charlotte, North Carolina  
Salt Lake City, Utah  84112