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

NCT00675948 | Completed Phase 3 Results

• 1 other identifier: GWEXT0101
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pain; Cancer

Keywords

Palliative Care; Pain; Cancer

Outcome Measures

Primary Outcomes (1)

• The Incidence of Adverse Events as a Measure of Subject Safety

  The number of subjects who experienced an adverse event in this study is presented.

  0 - 657 days

Secondary Outcomes (2)

• Change From Baseline in the Mean Brief Pain Inventory (Short Form) - Pain Severity Score at the End of Treatment

  0 - 657 days

• Change From Baseline in the Mean EORTC Quality of Life-C30 Questionnaire - Global Health Status Score at the End of Treatment

  0 - 657 days

Study Arms (2)

Sativex

EXPERIMENTAL

Active treatment

Drug: Sativex

GW-2000-02

EXPERIMENTAL

Active treatment

Drug: GW-2000-02

Interventions

Sativex DRUG

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.

Also known as: GW-1000-02

Sativex

GW-2000-02 DRUG

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.

GW-2000-02

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jazz Pharmaceuticals: lead

Study Sites (1)

Shropshire and Mid-Wales Hospice

Shrewsbury, SY3 8HS, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 23141881 RESULT

MeSH Terms

Conditions

Pain; Neoplasms

Interventions

nabiximols

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Mr Richard Potts, Clinical Operations Director
• Organization: GW Pharma LTD.

rp@gwpharm.com

00 44 1223 266 800

Study Officials

• Jeremy R Johnson, MB ChB

  Shropshire and Mid-Wales Hospice

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2008
• First Posted: May 12, 2008
• Study Start: April 1, 2002
• Primary Completion: September 1, 2006
• Study Completion: September 1, 2006
• Last Updated: May 3, 2023
• Results First Posted: September 13, 2012

Record last verified: 2023-04

Locations

GB (1)