Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study of Sativex® for Pain Relief in Patients With Advanced Malignancy (SPRAY)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00674609
Recruitment Status : Completed
First Posted : May 8, 2008
Results First Posted : August 13, 2012
Last Update Posted : June 20, 2013
Sponsor:
Information provided by:
GW Pharmaceuticals Ltd.

Tracking Information
First Submitted Date  ICMJE April 28, 2008
First Posted Date  ICMJE May 8, 2008
Results First Submitted Date  ICMJE July 5, 2012
Results First Posted Date  ICMJE August 13, 2012
Last Update Posted Date June 20, 2013
Study Start Date  ICMJE February 2002
Actual Primary Completion Date February 2004   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 5, 2012)
  • The Change in Mean Pain Numerical Rating Scale (NRS) Score From Baseline to the End of the Treatment. [ Time Frame: 2 weeks: baseline - end of week 2 (last 3 days of treatment) ]
    The 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 due to cancer. A negative value indicates an improvement in pain score from baseline.
  • The Consumption of Escape Analgesic Medication. [ Time Frame: 2 weeks: baseline - end of week 2 (last 3 days of treatment) ]
    Subjects recorded their use of escape medication each day on their diary card.
Original Primary Outcome Measures  ICMJE
 (submitted: May 7, 2008)
Measure of treatment efficacy was the change in pain score from baseline to end of treatment (week 2) and the use of breakthrough medication during the last three days of test treatment use in the study. [ Time Frame: Pain - end of 2 weeks; Breakthrough Medication - last three days of test treatment ]
Change History Complete list of historical versions of study NCT00674609 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 5, 2012)
  • Sleep Disturbance 0-10 Numerical Rating Scale [ Time Frame: 2 weeks: baseline to end of week 2 (last 3 days of treatment) ]
    The sleep disruption NRS was completed 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 how your pain disrupted your sleep last night?" where 0 = did not disrupt sleep and 10 = completely disrupted (unable to sleep at all). A negative value indicates an improvement in sleep disruption score from baseline.
  • Nausea 0-10 Numerical Rating Scale [ Time Frame: 2 weeks; baseline - end of week 2 (last 3 days of treatment) ]
    The nausea NRS was completed 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 how sick you felt throughout the day?" where 0 = not sick at all and 10 = very sick. A negative value indicates an improvement in nausea score from baseline.
  • Memory 0-10 Numerical Rating Scale [ Time Frame: 2 weeks: baseline - end of week 2 (last 3 days of treatment) ]
    The memory NRS was completed 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 how well you are able to remember what you have done in the past 24 hours?" where 0 = very well and 10 = not at all. A negative value indicates an improvement in memory score from baseline.
  • Appetite 0-10 Numerical Rating Scale [ Time Frame: 2 weeks: baseline - end of week 2 (last 3 days of treatment) ]
    The appetite NRS was completed 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 how your appetite has been throughout the day?" where 0 = very good and 10 = very poor. A negative value indicates an improvement in appetite score from baseline.
  • Concentration 0-10 Numerical Rating Scale [ Time Frame: 2 weeks: baseline - end of week 2 (last 3 days of treatment) ]
    The concentration NRS was completed 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 how well have you been able to concentrate throughout the day e.g. when reading a newspaper?" where 0 = very well and 10 = not at all. A negative value indicates an improvement in concentration score from baseline.
  • EORTC Quality of Life Questionnaire (EORTC-QLQC30) [ Time Frame: 2 weeks; baseline and end of treatment (2 weeks) ]
    Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30), a core cancer-specific questionnaire containing 30 items on patients' functioning, global quality of life, disease- and treatment related symptoms. Higher scores indicate a greater degree of symptoms, min.: 0, Max.: 100
  • Brief Pain Inventory Short Form [ Time Frame: End of 2 weeks ]
    The BPI-SF is a 14-item questionnaire that asks patients to rate pain over the prior week and the degree to which it interferes with activities on a 0 to 10 scale, where 0=no pain and 10=pain as bad as you can imagine. Severity is measured as worst pain, least pain, average pain, and pain right now. The severity composite score was calculated as the arithmetic mean of the four severity items(range 0-10). The minimum value is zero and maximum is 10. A higher score represents a poor outcome.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 7, 2008)
  • Use of regular maintenance medication [ Time Frame: End of 2 weeks ]
  • Sleep disturbance 0-10 NRS [ Time Frame: End of 2 weeks ]
  • Nausea 0-10 NRS [ Time Frame: End of 2 weeks ]
  • Memory 0-10 NRS [ Time Frame: End of 2 weeks ]
  • Appetite 0-10 NRS [ Time Frame: End of 2 weeks ]
  • Concentration 0-10 NRS [ Time Frame: End of 2 weeks ]
  • EORTC Quality of Life Questionnaire (EORTC-QLQC30) [ Time Frame: End of 2 weeks ]
  • Brief Pain Inventory Short Form [ Time Frame: End of 2 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Sativex® for Pain Relief in Patients With Advanced Malignancy
Official Title  ICMJE A Double Blind, Randomized, Parallel Group, Placebo Controlled, Comparative Study of the Efficacy, Safety and Tolerability of Cannabis Based Medicine (CBM) Extracts in Patients With Cancer-related Pain.
Brief Summary The purpose of this study is to determine whether Sativex® and GW-2000-02 are effective in the management of subjects with intractable cancer-related pain.
Detailed Description This is a two week (two days baseline and two weeks treatment period), multicentre, double blind, randomised, placebo controlled, parallel group study to evaluate the efficacy of Sativex® and GW-2000-02 in subjects with cancer-related pain. Subjects are screened to determine eligibility and completed a two-day baseline period. Subjects then return to the centre for assessment, randomisation and dose introduction. All subjects are allowed to continue using all their current medications, provided that the dose remains stable throughout the study period. Their progress is reviewed after seven to 10 days and at the end of the study (day 14 to 20), or upon withdrawal. Subjects in this study are given the opportunity to be enrolled in an open label extension study (GWEXT0101).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Palliative Care
  • Pain
  • Cancer
Intervention  ICMJE
  • Drug: Placebo
    Containing colourants and excipients. Subjects received study medication delivered in 100 µl actuations by a pump action oromucosal spray. Maximum permitted dose was eight actuations in any three hour period and 48 actuations in 24 hours.
    Other Name: GW-4000-01
  • Drug: Sativex®
    Containing D9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml. Subjects received study medication delivered in 100 µl actuations by a pump action oromucosal spray. Maximum permitted dose was eight actuations in any three hour period and 48 actuations (THC 130 mg:CBD 120 mg) in 24 hours.
    Other Name: GW-1000-02
  • Drug: THC Alone
    Containing THC, 27 mg/ml, as extract of Cannabis sativa L. Subjects received study medication delivered in 100 µl actuations by a pump action oromucosal spray. Maximum permitted dose was eight actuations in any three hour period and 48 actuations (THC 130 mg) in 24 hours.
    Other Names:
    • GW-2000-02
    • THC
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Placebo control
    Intervention: Drug: Placebo
  • Experimental: Sativex
    Active treatment
    Intervention: Drug: Sativex®
  • Experimental: THC Alone
    Active treatment
    Intervention: Drug: THC Alone
Publications * Johnson JR, Burnell-Nugent M, Lossignol D, Ganae-Motan ED, Potts R, Fallon MT. Multicenter, double-blind, randomized, placebo-controlled, parallel-group study of the efficacy, safety, and tolerability of THC:CBD extract and THC extract in patients with intractable cancer-related pain. J Pain Symptom Manage. 2010 Feb;39(2):167-79. doi: 10.1016/j.jpainsymman.2009.06.008. Epub 2009 Nov 5.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 7, 2008)
177
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2004
Actual Primary Completion Date February 2004   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Willing and able to give informed consent.
  • Male or female, age 18 years or above.
  • Diagnosed with cancer of any type, which is considered to be terminal.
  • Diagnosed with cancer-related pain which is not wholly alleviated with their current strong opioid treatment and whose level of pain measured on a NRS is ³four on at least one occasion per day, during the two day run-in period, leading up to visit 1.
  • On strong opioid maintenance therapy for at least seven days prior to the screening visit.
  • Willing to abstain from any use of cannabis during the study, other than the study medication.
  • No cannabinoids use (cannabis, Marinol® or Nabilone) for at least seven days before Visit 1 and willing to abstain from any use of cannabis during the study.
  • Clinically acceptable blood results at the screening visit.
  • Able (in the investigators opinion) and willing to undertake and comply with all study requirements.
  • Willing to allow their own general practitioner, and consultant if appropriate, to be informed of study participation.
  • Willing for the Home Office to be notified of his or her participation in the study (applicable to the UK centres only).

Exclusion Criteria:

  • Know history of substance misuse.
  • Known or suspected to have had an adverse reaction to cannabinoids causing psychosis or other severe psychiatric illness.
  • Received any epidural analgesia within 48 hours prior to study entry.
  • Either received, within two weeks of study entry, or due to receive chemotherapy or radiotherapy during the study.
  • Unable to give informed consent.
  • History of any type of schizophrenia, any other psychotic illness, a serious personality disorder, or other significant psychiatric illness other than depression associated with their chronic pain and/or in response to the underlying condition.
  • Currently taking levodopa (Sinemet®, Sinemet plus®, Levodopa®, L-dopa®, Madopar®, Benserazide®).
  • Had a serious cardiovascular disorder, including angina, uncontrolled hypertension, or an uncontrolled symptomatic cardiac arrhythmia.
  • Significant renal or hepatic impairment, who in the opinion of the investigator, were unsuitable for treatment with study medication.
  • History of epilepsy.
  • Had oral cavity cancers or whose previous treatments had included radiotherapy to the floor of the mouth.
  • Female subjects who were pregnant or lactating or of child-bearing potential and were inadequately protected against conception during the study and for three months thereafter.
  • Male subjects who were sexually active and who were not using adequate forms of contraception during the study and for three months thereafter.
  • Subjects who had participated in a clinical research study in the past four weeks, prior to study entry.
  • Planned travel outside the UK during the study (applicable to the UK centres only).
  • Subjects who, in the opinion of the investigator, were unsuitable to participate in the study for any other reason, not mentioned in the entry criteria.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00674609
Other Study ID Numbers  ICMJE GWCA0101
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mr Richard Potts/ Clinical Operations Director, GW Pharmaceuticals Ltd.
Study Sponsor  ICMJE GW Pharmaceuticals Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jeremy R Johnson, MB ChB Shropshire and Mid-Wales Hospice
PRS Account GW Pharmaceuticals Ltd.
Verification Date June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP