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A Double Blind, Randomized, Placebo Controlled, Parallel Group Dose-range Exploration Study of Sativex® in Relieving Pain in Patients With Advanced Cancer, Who Experience Inadequate Analgesia During Optimized Chronic Opioid Therapy.


Phase 2
18 Years
N/A
Not Enrolling
Both
Palliative Care, Pain, Cancer

Thank you

Trial Information

A Double Blind, Randomized, Placebo Controlled, Parallel Group Dose-range Exploration Study of Sativex® in Relieving Pain in Patients With Advanced Cancer, Who Experience Inadequate Analgesia During Optimized Chronic Opioid Therapy.


Inclusion Criteria:



- The patient has advanced active cancer for which there is no known curative therapy.

- The patient is able (in the investigators opinion) and willing to comply with all
study requirements.

- The patient has a clinical diagnosis of cancer related pain, which is not wholly
alleviated with their current opioid treatment.

- The patient is receiving a sustained release (SR) fixed dose of opioid therapy
(excluding Methadone). N.B. The opiate therapy must be Step III according to the
World Health Organization (WHO) analgesic ladder.

- The patient is willing to continue to take their regular daily baseline opioid
regimen (SR) at the same dose, throughout the duration of study.

Exclusion Criteria:

- The patient should be excluded from entering study if they have received or are due
to receive during the study period; chemotherapy, hormone therapy or radiotherapy,
which, in the opinion of the investigator will affect their pain.

- 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 diagnosed dependence disorder, current heavy
alcohol consumption, current use of an illicit drug or current non prescribed use of
any prescription drug.

- The patient has poorly controlled epilepsy or recurrent seizures (i.e. at least one
year since last seizure).

- The patient has experienced myocardial infarction or clinically relevant 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 relevant arrhythmia
or myocardial infarction.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Outcome Measure:

Number of Patients With at Least 30% Improvement in Numerical Rating Scale (NRS) Average Pain Score From Baseline

Outcome Description:

A positive 30% pain response is defined as a reduction of at least 30% in the mean NRS average pain score from baseline to week 5 (last 3 days). 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 due to cancer. The average pain NRS was completed at the same time each day, i.e. bedtime in the evening.

Outcome Time Frame:

5 Weeks: Baseline (first 3 days) - Week 5 (last 3 days)

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

GWCA0701

NCT ID:

NCT00530764

Start Date:

November 2007

Completion Date:

January 2010

Related Keywords:

  • Palliative Care
  • Pain
  • Cancer
  • Pain
  • Cancer
  • Palliative

Name

Location

Vanderbilt-Ingram Cancer CenterNashville, Tennessee  37232-6838
Huntsman Cancer InstituteSalt Lake City, Utah  84112
Beth Israel Medical CenterNew York, New York  10003
Lone Star OncologyAustin, Texas  78759
University of California San DiegoLa Jolla, California  92093
Gabrail Cancer CenterCanton, Ohio  44718
Center For Clinical ResearchWinston Salem, North Carolina  27103
Pacific Coast Hematology/Oncology Medical Group, Inc.Fountain Valley, California  92708
Clinical Pharmacology ServicesTampa, Florida  
Florida Institute of Medical ResearchJacksonville, Florida  32207
Loma Linda UniversityLoma Linda, California  92354
Desert Oasis Cancer CenterCasa Grande, Arizona  85222
Summit Medical GroupSummit, New Jersey  07901
Capital Comprehensive Cancer Care ClinicJefferson City, Missouri  65109
Cancer Care Center of TuscaloosaTuscaloosa, Alabama  35406
Office of Dr. Ronald YanagiharaGilroy, California  95020
Center of Hope for Cancer and Blood DisordersRiverdale, Georgia  30274
Louisiana Research AssociatesNew Orleans, Louisiana  70114
The Center for Clinical Research - Washington County HospitalHagerstown, Maryland  21740
A & A Pain Institute of St. LouisSt. Louis, Missouri  63141
Office of Donald H. Berdeaux MDGreat Falls, Montana  59405
Metropolitan Hospital CenterNew York, New York  10029
Four Seasons Hospice & Pallative CareFlat Rock, North Carolina  28731