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Palliative CarePhase 2SPRAYNCT00530764

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

A Phase 2 study testing Sativex Low Dose, Sativex Medium Dose and Sativex High Dose in people with Palliative Care and Pain, run by GW Pharmaceuticals Ltd at 110 sites in 16 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to determine the effective dose range and to demonstrate a non-effective dose range of Sativex in patients with advanced cancer, who experience inadequate pain relief even though they are on optimized chronic opioid therapy. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Palliative Care, Pain, Cancer
What is being tested?
Sativex Low Dose, Sativex Medium Dose and Sativex High Dose
Could I receive a placebo?
No, everyone receives an active treatment
How many people
360 participants
Where
110 sitesin 16 countries
Study dates
Nov 2007to Jan 2010
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The patient has advanced active cancer for which there is no known curative therapy.
  • The patient is able (in the investigators opinion) and willing to comply with all study requirements.
  • The patient has a clinical diagnosis of cancer related pain, which is not wholly alleviated with their current opioid treatment.
  • The patient is receiving a sustained release (SR) fixed dose of opioid therapy (excluding Methadone). N.B. The opiate therapy must be Step III according to the World Health Organization (WHO) analgesic ladder.
  • The patient is willing to continue to take their regular daily baseline opioid regimen (SR) at the same dose, throughout the duration of study.

Who cannot join

  • The patient should be excluded from entering study if they have received or are due to receive during the study period; chemotherapy, hormone therapy or radiotherapy, which, in the opinion of the investigator will affect their pain.
  • Any history or immediate family history of schizophrenia, other psychotic illness, severe personality disorder or other significant psychiatric disorder other than depression associated with their underlying condition.
  • Any known or suspected history of a diagnosed dependence disorder, current heavy alcohol consumption, current use of an illicit drug or current non prescribed use of any prescription drug.
  • The patient has poorly controlled epilepsy or recurrent seizures (i.e. at least one year since last seizure).
  • The patient has experienced myocardial infarction or clinically relevant cardiac dysfunction within the last 12 months or has a cardiac disorder that, in the opinion of the investigator would put the patient at risk of a clinically relevant arrhythmia or myocardial infarction.

Trial locations and contacts

110 sites in 16 countries.

110 sites in 16 countries

United States23 sites

  • Lone Star Oncology

    Austin, Texas, 78759

  • Summit Medical Group

    Berkeley Heights, New Jersey, 07922

  • Gabrail Cancer Center

    Canton, Ohio, 44718

  • Desert Oasis Cancer Center

    Casa Grande, Arizona, 85222

  • Four Seasons Hospice & Pallative Care

    Flat Rock, North Carolina, 28731

  • Pacific Coast Hematology/Oncology Medical Group, Inc.

    Fountain Valley, California, 92708

  • Office of Dr. Ronald Yanagihara

    Gilroy, California, 95020

  • Office of Donald H. Berdeaux MD

    Great Falls, Montana, 59405

  • The Center for Clinical Research - Washington County Hospital

    Hagerstown, Maryland, 21740

  • Florida Institute of Medical Research

    Jacksonville, Florida, 32257

  • Capital Comprehensive Cancer Care Clinic

    Jefferson City, Missouri, 65109

  • University of California San Diego

    La Jolla, California, 92037

  • Loma Linda University

    Loma Linda, California, 92354

  • Vanderbilt-Ingram Cancer Center

    Nashville, Tennessee, 37232

  • Louisiana Research Associates

    New Orleans, Louisiana, 70114

  • Beth Israel Medical Center

    New York, New York, 10003

  • Metropolitan Hospital Center

    New York, New York, 10029

  • Center of Hope for Cancer and Blood Disorders

    Riverdale, Georgia, 30274

  • Huntsman Cancer Institute

    Salt Lake City, Utah, 84112

  • A & A Pain Institute of St. Louis

    St Louis, Missouri, 63141

  • Clinical Pharmacology Services

    Tampa, Florida, 33617

  • Cancer Care Center of Tuscaloosa

    Tuscaloosa, Alabama, 35406

  • Center for Clinical Research

    Winston-Salem, North Carolina, 27103

Other trials in United States

India13 sites

  • Yashoda Hospital

    Andhra Pradesh, 500 082

  • Bangalore Institute of Oncology

    Bangalore, 560027

  • CBCC- Apollo Hospital

    Gandhinagar

  • Apollo Hospital

    Hyderabaad, 500033

  • Indo-American Cancer Institute and Research Center

    Hyderabaad, 500034

  • Bhagwaan Mahaveer Cancer Hospital and Research Centre

    Jaipur, 302017

  • CHL - Apollo Hospitals

    Madhya Pradesh, 452 008

  • Jawaharlal Nehru Cancer Hospital

    Madhya Pradesh, 462 001

  • Meenakshi Mission Hospital & Research Centre

    Madurai, 625107

  • All India Institute of Medical Sciences

    New Delhi, 110 029

  • Jehangir Clinical Development Centre Pvt. Ltd.

    Pune, 411001

  • Deenanath Mangeshkar Hospital and Research Center

    Pune

  • Seroc Cancer Center

    Rajasthan, 302 013

Other trials in India

Romania12 sites

  • Spitalul Judetean de Urgenta "Constantin Opris"

    Baia Mare, Maramures, 430031

  • Spitalul Judetean de Urgenta Braila

    Braila, Jud. Braila, 810325

  • Hospice "Casa Sperantei"

    Brasov, 500074

  • Spitalul Universitar de Urgenta Elias

    Bucharest, 011461

  • S.C. IanuliMed S.R.L. Oncologie Medicala

    Bucharest, 020962

  • Policnica Orizont-Oncologie Medicala

    Craiova, 200535

  • District Hospital Dr. Alexandru Simionescu

    Hunedoara, 331057

  • Centrul de Oncologie Medicala

    Iași, 700106

  • Spitalul Municipal Onesti

    Onesti, Jud. Bacau, 601048

  • Spitalul Municipal Ploiesti

    Ploieşti, 100337

  • Spitalul Clinic Judetean Sibiu Oncologie

    Sibiu, 550245

  • Spitalul Judetean de Urgenta "Sf. Ioan cel Nou"

    Suceava, 720237

Other trials in Romania

United Kingdom12 sites

  • Basingstoke & North Hampshire NHS Foundation Trust

    Basingstoke, RG24 9NA

  • West Suffolk Hospital

    Bury St Edmunds, IP33 2QZ

  • Fairfield General Hospital

    Bury, Lancashire, BL9 7TD

  • Edinburgh Cancer Research Centre (CRUK)

    Edinburgh, EH4 2XR

  • James Paget Hospital

    Gorleston on Sea, Norfolk, NR31 6LA

  • International Observatory on End of Life Care

    Lancaster, LA1 4YT

  • St Bartholomew's Hospital

    London, EC1A 7BE

  • The Royal Marsden NHS Foundation Trust

    London, SW3 6LL

  • Marie Curie Hospice Holme Tower

    Penarth, CF64 3YR

  • The Royal Marsden NHS Foundation Trust

    Sutton, SM2 5PT

  • Weston Area Health Trust

    Weston-super-Mare, BS23 4TQ

  • New Cross Hospital

    Wolverhampton, WV10 0QP

Other trials in United Kingdom

Czechia9 sites

  • Ambulance pro lécbu bolesti, ARO

    Benešov, 25601

  • Ambulance pro lécbu bolesti

    České Budějovice, 370 01

  • Nemocnice Ceské Budejovice

    České Budějovice, 370 87

  • FN Hradec Králové - Klinika onkologie a radioterapie

    Hradec Králové, 500 05

  • Nemocnice Jihlava

    Jihlava, 58633

  • FN a LF UP Olomouc - Ambulance pro lécbu bolesti

    Olomouc, 775 20

  • AR klinika FN Plzen -Ambulance pro lécbu bolesti

    Pilsen, 304 60

  • Fakultní nemocnice Na Bulovce

    Praha 8 - Liben, 180 81

  • ARO, Krajská zdravotni, K.Z. a.s, Nemocnice

    Teplice, 41501

Other trials in Czechia

Poland8 sites

  • Beskidzkie Centrum Onkologii im. Jana Pawla

    Bielsko-Biala, 43-300

  • Poradnia Leczenia Bolu

    Edyty Jakubow

  • Wojewodzki Szpital Specjalistyczny im. M. Kopernika

    Gdansk, 80-803

  • NZOZ Hospicjum Milosierdzia Bozego

    Gliwice, 44-101

  • Szpital Uniwersytecki w Krakowie

    Krakow, 31-631

  • Wielkopolskie Centrum Onkologii

    Poznan, 61-866

  • Niepubliczny Zaklad Opieki Zdrowotnej

    Tychy, 43-100

  • Centrum Onkologii - Instytut im. M. Sklodowskiej - Curie

    Warsaw, 02-781

Other trials in Poland

Spain8 sites

  • Hospital Virgen del Mar

    Almería, 04003

  • Hospital Universitario Vall d'Hebron

    Barcelona, 08035

  • Hospital Clinic i Provincial

    Barcelona, 08036

  • HU Puerta del Mar, Oncologia

    Cadiz, 11009

  • Hospital Universitario de Bellvitge

    Feixa, Llarga, Sn, 08907

  • Hospital Univ. Virgen de las Nieves

    Granada, 180114

  • Hospital de la Rioja

    Logroño, 26001

  • Hospital Los Montalvos

    Salamanca, 37192

Other trials in Spain

South Africa7 sites

  • Medi Clinic

    Bloemfontein, 9301

  • Pain Clinic

    Cape Town, 8001

  • Dr. Pirjol & Szpak Inc.

    eManzimtoti, 4126

  • Pretoria Urology Research Unit

    Hatfield, Pretoria, 0083

  • Trialtech Research - Embassy Drive Medical Centre

    Hatfield, Pretoria, 0083

  • Oncology/Haematology Dept Research Unit

    Kimberley, 8301

  • Eastleigh Breast Cancer Center

    Lynnwood, 0041

Other trials in South Africa

Germany4 sites

  • RWTH Aachen Universität

    Aachen, 52074

  • Schmerz- und Palliativzentrum Göppingen

    Göppingen, 73033

  • St.-Marien-Hospital Lunen

    Lünen, 44534

  • Schmeiz - u Pallielivzendium Wiesbaden

    Wiesbaden, 65189

Other trials in Germany

Belgium3 sites

  • Jules Bordet Institute

    Brussels, 1000

  • CHU Charleroi (Hôpital civil de Charleroi)

    Charleroi, 6000

  • UZ Leuven - Algologisch Centrum Anesthesiologie

    Pellenberg, 3212

Other trials in Belgium

Canada2 sites

  • Jewish General Hospital

    Montreal, Quebec, H3T 1E2

  • Vancouver Health Research Center

    Victoria, British Columbia, V8V 1R2

Other trials in Canada

Chile2 sites

  • Instituto Radio-oncológico Santiago (INRAD)

    Santiago

  • Clínica Ciudad del Mar

    Viña del Mar

Other trials in Chile

France2 sites

  • Centre hospitalier Lyon Sud

    Pierre-Bénite, 69495

  • Praticien hospitalier

    Tarbes, 65000

Other trials in France

Italy2 sites

  • Regina Elana Cancer Institute

    Rome, 00144

  • Dir. S.C.D.U. Psicologia Clinica ed Oncologica

    Turin, 10128

Other trials in Italy

Mexico2 sites

  • Hospital Aranda de la Parra

    León, 37000

  • Htal Ángeles de Pedregal

    Mexico City, 10700

Other trials in Mexico

Finland1 site

  • Docrates Clinic

    Helsinki, 00150

Other trials in Finland

About this study

Official title: A Double Blind, Randomized, Placebo Controlled, Parallel Group Dose-range Exploration Study of Sativex® in Relieving Pain in Patients With Advanced Cancer, Who Experience Inadequate Analgesia During Optimized Chronic Opioid Therapy.

The purpose of this study is to determine the effective dose range and to demonstrate a non-effective dose range of Sativex in patients with advanced cancer, who experience inadequate pain relief even though they are on optimized chronic opioid therapy.

Being tested
Sativex Low Dose, Sativex Medium Dose, Sativex High Dose
Keywords
Pain, Cancer, Palliative
Medical subject headings
Pain, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sativex Low DoseDrug

    Also called GW-1000-02

    Range of 1 to 4 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 10.8mg THC and 10mg CBD.

  • Sativex Medium DoseDrug

    Also called GW-1000-02

    Range of 6 to 10 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 27mg THC and 25mg CBD.

  • Sativex High DoseDrug

    Also called GW-1000-02

    Range of 11 to 16 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 43.2mg THC and 40mg CBD.

Study groups in NCT00530764
Study groupRoleWhat they receive
Sativex Low DoseExperimentalRange of 1 to 4 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 10.8mg THC and 10mg CBD.
Receives: Drug: Sativex Low Dose
Sativex Medium DoseExperimentalRange of 6 to 10 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 27mg THC and 25mg CBD.
Receives: Drug: Sativex Medium Dose
Sativex High DoseExperimentalRange of 11 to 16 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 43.2mg THC and 40mg CBD.
Receives: Drug: Sativex High Dose
PlaceboNo interventionRange of 1-16 sprays per day of placebo spray.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Patients With at Least 30% Improvement in Numerical Rating Scale (NRS) Average Pain Score From Baseline

    A positive 30% pain response is defined as a reduction of at least 30% in the mean NRS average pain score from baseline to week 5 (last 3 days). 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. The average pain NRS was completed at the same time each day, i.e. bedtime in the evening.

    Measured: 5 Weeks: Baseline (first 3 days) - Week 5 (last 3 days)

Secondary outcomes (8)

  1. Change in Cumulative Average Pain Response Curves

    The cumulative response to treatment is the percentage changes from baseline in the mean NRS pain score as defined as the 30% response.

    The pain NRS was completed 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.

    Measured: Baseline to end of treatment (Week 5)

  2. Change in Mean Daily NRS Pain Score (Average Pain).

    The average 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.

    Measured: 5 Weeks: Baseline (first 3 days) - End of Treatment (last 3 days of week 5)

  3. Change in Mean Daily NRS Pain Score (Worst Pain).

    The worst pain NRS was completed 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 worst 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 worst pain score from baseline.

    Measured: 5 Weeks: Baseline (first 3 days) - End of Treatment (last 3 days of week 5)

  4. Change in Sleep Disruption NRS

    The sleep disruption NRS was completed 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 how your pain disrupted your sleep last night?" where 0 = did not disrupt sleep and 10 = completely disrupted (unable to sleep at all). A negative value indicates an improvement in sleep disruption score from baseline.

    Measured: 5 Weeks: Baseline - End of Treatment (Last 3 days of Week 5)

  5. Change in Brief Pain Inventory - Short Form (BPI-SF)

    The BPI-SF is a 14-item questionnaire that asks patients 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 higher score represents a poor outcome.

    Measured: Baseline (Visit 2) and End of Treatment (End of Week 5 or premature termination)

  6. Change in Patient Assessment of Constipation Quality of Life (PAC-QoL)

    The PAC-QoL questionnaire consists of 28 questions divided into the following areas: 4 questions on physical discomfort, 8 questions on psychosocial discomfort, 11 questions on worries/concerns and 5 questions on satisfaction. The PAC-QoL was completed at baseline and then at the end of treatment. An overall score (range 0-4) was calculated at each visit and the difference determined. A positive difference in score represents an improvement.

    Measured: Baseline (Visit 2) and End of Treatment (Week 5 or premature termination)

  7. Change in Patient Global Impression of Change - PGIC

    A 7-point Likert-type scale was used, with the question: 'Please assess the status of your pain due to cancer since entry into the study using the scale below' with the markers "very much improved, much improved, slightly improved, no change, slightly worse, much worse or very much worse". At Visit 2 (Baseline) patients wrote a brief description of their pain caused by cancer which was used at Week 5 to aid their memory regarding their symptoms at study start. For each of above markers the number of participants were reported.

    Measured: End of Week 5

  8. Change in Montgomery Asberg Depression Rating Scale (MADRS)

    The MADRS comprises of 10 questions that are completed by the patient to determine their depression level. The MADRS was completed at Visit 2 (Baseline) prior to receiving the study drug and at Visit 4 (Week 5 or premature termination). Each item is scored on a 0-6 scale , where 0=no sadness to 6=extreme and continuous gloom and despondency, and the MADRS score is the sum of the 10 item scores (range 0-60). The higher the score the more severe the depression.

    Measured: Baseline and End of Treatment (Week 5 or premature termination)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Sep 2007 (estimated)
  2. Study startNov 2007
  3. Primary completionJan 2010
  4. Study completionJan 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
360 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00530764
Sponsor's protocol ID
GWCA0701
Acronym
SPRAY
Status last verified
Jun 2013
First submitted
13 Sep 2007
Last updated
20 Jun 2013
Data monitoring committee
Yes

Publications

  • Portenoy RK, Ganae-Motan ED, Allende S, Yanagihara R, Shaiova L, Weinstein S, McQuade R, Wright S, Fallon MT. Nabiximols for opioid-treated cancer patients with poorly-controlled chronic pain: a randomized, placebo-controlled, graded-dose trial. J Pain. 2012 May;13(5):438-49. doi: 10.1016/j.jpain.2012.01.003. Epub 2012 Apr 5.

    PubMed 22483680

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sativex Low Dose, Sativex Medium Dose and Sativex High Dose in people with Palliative Care and Pain, run by GW Pharmaceuticals Ltd at 110 sites in 16 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 110 sites in United States, India, Romania, United Kingdom, Czechia and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Jun 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Patients With at Least 30% Improvement in Numerical Rating Scale (NRS) Average Pain Score From Baseline (time frame: 5 Weeks: Baseline (first 3 days) - Week 5 (last 3 days)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00530764, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2013.

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