Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study to Compare the Safety and Tolerability of Sativex® in Patients With Cancer Related Pain

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: NCT00675948
Recruitment Status : Completed
First Posted : May 12, 2008
Results First Posted : September 13, 2012
Last Update Posted : June 24, 2013
Sponsor:
Information provided by (Responsible Party):
GW Pharmaceuticals Ltd.

Tracking Information
First Submitted Date  ICMJE May 8, 2008
First Posted Date  ICMJE May 12, 2008
Results First Submitted Date  ICMJE July 5, 2012
Results First Posted Date  ICMJE September 13, 2012
Last Update Posted Date June 24, 2013
Study Start Date  ICMJE April 2002
Actual Primary Completion Date September 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 14, 2012)
The Incidence of Adverse Events as a Measure of Subject Safety [ Time Frame: 0 - 657 days ]
The number of subjects who experienced an adverse event in this study is presented.
Original Primary Outcome Measures  ICMJE
 (submitted: May 9, 2008)
Assessment of long term safety and tolerability of Sativex and GW-2000-02 in subjects with cancer related pain by monitoring the number, frequency and type of adverse events reported by subjects. [ Time Frame: 7-10 days after Visit 1 and then every four weeks ]
Change History Complete list of historical versions of study NCT00675948 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 14, 2012)
  • Change From Baseline in the Mean Brief Pain Inventory (Short Form) - Pain Severity Score at the End of Treatment [ Time Frame: 0 - 657 days ]
    The Brief Pain Inventory (Short Form) is a 14-item questionnaire that asks subjects 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 negative value indicates an improvement in score from baseline. The end of treatment was classed as study completion or withdrawal, if this occurred sooner. Calculation of the mean Brief Pain Inventory (Short Form) score was only carried out when data was available for 10 or more subjects at the relevant study visits. As such, no mean scores were calculated for subjects taking THC alone.
  • Change From Baseline in the Mean EORTC Quality of Life-C30 Questionnaire - Global Health Status Score at the End of Treatment [ Time Frame: 0 - 657 days ]
    The EORTC Quality of Life-C30 Health Status visual analogue scale was a self-reported score where subjects rated their health state from: 0 = worst health state imaginable to 100 = best health state imaginable. An increase in score from baseline indicates an improvement in condition. The end of treatment was classed as study completion or withdrawal, if this occurred sooner. Calculation of mean EORTC Quality of Life-C30 Health Status scores was only produced when data was available for 10 or more subjects at the relevant study visits. As such, no mean scores were calculated for subjects taking THC alone.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 9, 2008)
  • Laboratory parameters pre and post-treatment [ Time Frame: Every four weeks ]
  • Use of rescue medication [ Time Frame: 7-10 days after Visit 1 and then every four weeks ]
  • Use of maintenance analgesic medication [ Time Frame: 7-10 days after Visit 1 and then every four weeks ]
  • Pain severity 0-10 NRS [ Time Frame: 7-10 days after Visit 1 and then every four weeks ]
  • Health 0-10 NRS [ Time Frame: 7-10 days after Visit 1 and then every four weeks ]
  • EORTC quality of life questionnaire [ Time Frame: 7-10 days after Visit 1 and then every four weeks ]
  • Brief Pain Inventory Short Form [ Time Frame: 7-10 days after Visit 1 and then every four weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Compare the Safety and Tolerability of Sativex® in Patients With Cancer Related Pain
Official Title  ICMJE An Open-label, Extension Study, to Investigate the Long-term Safety and Tolerability of Cannabis Based Medicine Extracts in Patients With Cancer-related Pain.
Brief Summary The purpose of this study is to assess the safety and tolerability of long term therapy with Sativex® and GW-2000-02.
Detailed Description Subjects who have previously participated in GWCA0101, 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® (containing delta-9-tetrahydrocannabinol [THC] and cannabidiol [CBD]) and GW-2000-02 (containing THC alone) in subjects with cancer-related pain are screened, and if eligible begin dosing with open-label Sativex®. They are allowed to self-titrate their study medication to symptom resolution or maximum tolerated/allowable dose of 130 mg THC and 120 mg CBD and have the opportunity to request a change from Sativex® to GW-2000-02 if they or the investigator consider their response less than optimal. Subjects are reviewed for tolerability and evidence of clinical benefit at 7-10 days after Visit 1 and then every four weeks. Continuation within the study is conditional on satisfactory reports of tolerability, efficacy and dosing regime.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Pain
  • Cancer
Intervention  ICMJE
  • Drug: Sativex

    Containing delta-9-tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml; both 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:CBD 120 mg) in 24 hours.

    Other Name: GW-1000-02
  • Drug: GW-2000-02
    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.
Study Arms  ICMJE
  • Experimental: Sativex
    Active treatment
    Intervention: Drug: Sativex
  • Experimental: GW-2000-02
    Active treatment
    Intervention: Drug: GW-2000-02
Publications * Johnson JR, Lossignol D, Burnell-Nugent M, Fallon MT. An open-label extension study to investigate the long-term safety and tolerability of THC/CBD oromucosal spray and oromucosal THC spray in patients with terminal cancer-related pain refractory to strong opioid analgesics. J Pain Symptom Manage. 2013 Aug;46(2):207-18. doi: 10.1016/j.jpainsymman.2012.07.014. Epub 2012 Nov 8.

*   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 9, 2008)
43
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2006
Actual Primary Completion Date September 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Willing and eligible to continue into the extension study from GWCA0101.
  • Complied adequately with the study requirements, as detailed in GWCA0101.
  • In the investigator's opinion able to undertake and comply with all of the study requirements (it is understood that progress of the disease may accelerate and affect this ability).
  • Willing and able to read, consider and understand the subject information and consent form and to give written informed consent in compliance with the Declaration of Helsinki1.
  • Willing to allow their own general practitioner, and consultant if appropriate, to be informed of study participation.
  • Willing for their name to be notified to the Home Office for participation in the trial.

Exclusion Criteria:

  • Have not participated in GWCA0101.
  • Have not complied adequately with the study requirements, as detailed in GWCA0101.
  • Experienced an unacceptable adverse event, whilst participating in GWCA0101.
  • Known or suspected to have had an adverse reaction to cannabinoids causing psychosis or other severe psychiatric illness.
  • 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®).
  • Has a serious cardiovascular disorder, including angina, uncontrolled hypertension, or an uncontrolled symptomatic cardiac arrhythmia.
  • Has significant renal or hepatic impairment, which in the opinion of the investigator, are unsuitable for treatment with Investigational Medicinal Product.
  • History of epilepsy.
  • Female subjects of child bearing potential and male subjects whose partner is of child bearing potential, unless willing to ensure that they or their partner use effective contraception during the study and for three months thereafter.
  • If female, are pregnant or lactating, or are planning pregnancy during the course of the study and for three months thereafter.
  • Have oral cavity cancers or whose previous treatments had included radiotherapy to the floor of the mouth.
  • In the opinion of the investigator, are unsuitable to participate in the study for any other reason, not mentioned in the inclusion and exclusion 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 NCT00675948
Other Study ID Numbers  ICMJE GWEXT0101
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party 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