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

Sponsor:	GW Pharmaceuticals Ltd.
Information provided by:	GW Pharmaceuticals Ltd.
ClinicalTrials.gov Identifier:	NCT00675948

Purpose

The purpose of this study is to assess the safety and tolerability of long term therapy with Sativex® and GW-2000-02.

Condition	Intervention	Phase
Palliative Care Pain Cancer	Drug: Sativex® Drug: GW-2000-02	Phase III

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Supportive Care
Official Title:	An Open-Label, Extension Study, to Investigate the Long-Term Safety and Tolerability of Cannabis Based Medicine (CBM) Extracts in Patients With Cancer-Related Pain.

Resource links provided by NLM:

MedlinePlus related topics: Cancer Palliative Care

Drug Information available for: GW-1000 Cannabis

U.S. FDA Resources

Further study details as provided by GW Pharmaceuticals Ltd.:

Primary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Laboratory parameters pre and post-treatment [ Time Frame: Every four weeks ] [ Designated as safety issue: No ]
Use of rescue medication [ Time Frame: 7-10 days after Visit 1 and then every four weeks ] [ Designated as safety issue: No ]
Use of maintenance analgesic medication [ Time Frame: 7-10 days after Visit 1 and then every four weeks ] [ Designated as safety issue: No ]
Pain severity 0-10 NRS [ Time Frame: 7-10 days after Visit 1 and then every four weeks ] [ Designated as safety issue: No ]
Health 0-10 NRS [ Time Frame: 7-10 days after Visit 1 and then every four weeks ] [ Designated as safety issue: No ]
EORTC quality of life questionnaire [ Time Frame: 7-10 days after Visit 1 and then every four weeks ] [ Designated as safety issue: No ]
Brief Pain Inventory Short Form [ Time Frame: 7-10 days after Visit 1 and then every four weeks ] [ Designated as safety issue: No ]

Enrollment:	43
Study Start Date:	April 2002
Study Completion Date:	September 2006
Primary Completion Date:	September 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: A	Drug: Sativex® Containing D9 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-10000-02
Experimental: B	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. Other Name: 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® and GW-2000-02 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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 AE, 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 IMP.
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00675948

Locations

United Kingdom
Shropshire and Mid-Wales Hospice
Shrewsbury, United Kingdom, SY3 8HS

Sponsors and Collaborators

GW Pharmaceuticals Ltd.

Investigators

Principal Investigator:

Jeremy R Johnson, MB ChB

Shropshire and Mid-Wales Hospice

More Information

No publications provided

Responsible Party:	Mr Richard Potts/ Clinical Operations Director, GW Pharmaceuticals Ltd
ClinicalTrials.gov Identifier:	NCT00675948 History of Changes
Other Study ID Numbers:	GWEXT0101
Study First Received:	May 8, 2008
Last Updated:	July 10, 2008
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency; Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment

Keywords provided by GW Pharmaceuticals Ltd.:

Palliative Care
Pain
Cancer

ClinicalTrials.gov processed this record on February 12, 2012