Status:
COMPLETED
A Study of Sativex® for Pain Relief in Patients With Advanced Malignancy
Lead Sponsor:
Jazz Pharmaceuticals
Conditions:
Palliative Care
Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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-...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2004
Estimated Enrollment :
177 Patients enrolled
Trial Details
Trial ID
NCT00674609
Start Date
February 1 2002
End Date
March 1 2004
Last Update
May 3 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Shropshire and Mid-Wales Hospice
Shrewsbury, United Kingdom, SY3 8HS