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

NCT00674609 | Completed Phase 3 Results

• 1 other identifier: GWCA0101
• Study Type: interventional
• Target: 177
• Locations: 1 country
• Sites: 1

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.

Conditions

Palliative Care; Pain; Cancer

Keywords

Palliative Care; Pain; Cancer

Outcome Measures

Primary Outcomes (2)

• The Change in Mean Pain Numerical Rating Scale (NRS) Score From Baseline to the End of the 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.

  2 weeks: baseline - end of week 2 (last 3 days of treatment)

• The Consumption of Escape Analgesic Medication.

  Subjects recorded their use of escape medication each day on their diary card.

  2 weeks: baseline - end of week 2 (last 3 days of treatment)

Secondary Outcomes (7)

• Sleep Disturbance 0-10 Numerical Rating Scale

  2 weeks: baseline to end of week 2 (last 3 days of treatment)

• Nausea 0-10 Numerical Rating Scale

  2 weeks; baseline - end of week 2 (last 3 days of treatment)

• Memory 0-10 Numerical Rating Scale

  2 weeks: baseline - end of week 2 (last 3 days of treatment)

• Appetite 0-10 Numerical Rating Scale

  2 weeks: baseline - end of week 2 (last 3 days of treatment)

• Concentration 0-10 Numerical Rating Scale

  2 weeks: baseline - end of week 2 (last 3 days of treatment)

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Placebo control

Drug: Placebo

Sativex

EXPERIMENTAL

Active treatment

Drug: Sativex®

THC Alone

EXPERIMENTAL

Active treatment

Drug: THC Alone

Interventions

Placebo DRUG

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.

Also known as: GW-4000-01

Placebo

Sativex® DRUG

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.

Also known as: GW-1000-02

Sativex

THC Alone 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.

Also known as: GW-2000-02, THC

THC Alone

Eligibility Criteria

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

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Jazz Pharmaceuticals: lead

Study Sites (1)

Shropshire and Mid-Wales Hospice

Shrewsbury, SY3 8HS, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 19896326 RESULT

MeSH Terms

Conditions

Pain; Neoplasms

Interventions

nabiximols; Dronabinol

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Results Point of Contact

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

rp@gwpharm.com

0044 1223 266800

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: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 28, 2008
• First Posted: May 8, 2008
• Study Start: February 1, 2002
• Primary Completion: February 1, 2004
• Study Completion: March 1, 2004
• Last Updated: May 3, 2023
• Results First Posted: August 13, 2012

Record last verified: 2023-04

Locations

GB (1)