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

NCT00530764 | Completed Phase 2 Results DMC

• 1 other identifier: GWCA0701
• Study Type: interventional
• Target: 360
• Locations: 16 countries
• Sites: 110

Brief 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.

Conditions

Palliative Care; Pain; Cancer

Keywords

Pain; Cancer; Palliative

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (8)

• Change in Cumulative Average Pain Response Curves

  Baseline to end of treatment (Week 5)

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

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

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

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

• Change in Sleep Disruption NRS

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

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

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

Study Arms (4)

Sativex Low Dose

EXPERIMENTAL

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.

Drug: Sativex Low Dose

Sativex Medium Dose

EXPERIMENTAL

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.

Drug: Sativex Medium Dose

Sativex High Dose

EXPERIMENTAL

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.

Drug: Sativex High Dose

Placebo

NO INTERVENTION

Range of 1-16 sprays per day of placebo spray.

Interventions

Sativex Low Dose DRUG

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.

Also known as: GW-1000-02

Sativex Low Dose

Sativex Medium Dose DRUG

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.

Also known as: GW-1000-02

Sativex Medium Dose

Sativex High Dose DRUG

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.

Also known as: GW-1000-02

Sativex High Dose

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GW Pharmaceuticals Ltd: lead
• Quintiles, Inc.: collaborator

Study Sites (110)

Cancer Care Center of Tuscaloosa

Tuscaloosa, Alabama, 35406, United States

Location

Desert Oasis Cancer Center

Casa Grande, Arizona, 85222, United States

Location

Pacific Coast Hematology/Oncology Medical Group, Inc.

Fountain Valley, California, 92708, United States

Location

Office of Dr. Ronald Yanagihara

Gilroy, California, 95020, United States

Location

University of California San Diego

La Jolla, California, 92037, United States

Location

Loma Linda University

Loma Linda, California, 92354, United States

Location

Florida Institute of Medical Research

Jacksonville, Florida, 32257, United States

Location

Clinical Pharmacology Services

Tampa, Florida, 33617, United States

Location

Center of Hope for Cancer and Blood Disorders

Riverdale, Georgia, 30274, United States

Location

Louisiana Research Associates

New Orleans, Louisiana, 70114, United States

Location

The Center for Clinical Research - Washington County Hospital

Hagerstown, Maryland, 21740, United States

Location

Capital Comprehensive Cancer Care Clinic

Jefferson City, Missouri, 65109, United States

Location

A & A Pain Institute of St. Louis

St Louis, Missouri, 63141, United States

Location

Office of Donald H. Berdeaux MD

Great Falls, Montana, 59405, United States

Location

Summit Medical Group

Berkeley Heights, New Jersey, 07922, United States

Location

Beth Israel Medical Center

New York, New York, 10003, United States

Location

Metropolitan Hospital Center

New York, New York, 10029, United States

Location

Four Seasons Hospice & Pallative Care

Flat Rock, North Carolina, 28731, United States

Location

Center for Clinical Research

Winston-Salem, North Carolina, 27103, United States

Location

Gabrail Cancer Center

Canton, Ohio, 44718, United States

Location

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232, United States

Location

Lone Star Oncology

Austin, Texas, 78759, United States

Location

Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Location

Jules Bordet Institute

Brussels, 1000, Belgium

Location

CHU Charleroi (Hôpital civil de Charleroi)

Charleroi, 6000, Belgium

Location

UZ Leuven - Algologisch Centrum Anesthesiologie

Pellenberg, 3212, Belgium

Location

Vancouver Health Research Center

Victoria, British Columbia, V8V 1R2, Canada

Location

Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

Instituto Radio-oncológico Santiago (INRAD)

Santiago, Chile

Location

Clínica Ciudad del Mar

Viña del Mar, Chile

Location

Ambulance pro lécbu bolesti, ARO

Benešov, 25601, Czechia

Location

Ambulance pro lécbu bolesti

České Budějovice, 370 01, Czechia

Location

Nemocnice Ceské Budejovice

České Budějovice, 370 87, Czechia

Location

FN Hradec Králové - Klinika onkologie a radioterapie

Hradec Králové, 500 05, Czechia

Location

Nemocnice Jihlava

Jihlava, 58633, Czechia

Location

FN a LF UP Olomouc - Ambulance pro lécbu bolesti

Olomouc, 775 20, Czechia

Location

AR klinika FN Plzen -Ambulance pro lécbu bolesti

Pilsen, 304 60, Czechia

Location

Fakultní nemocnice Na Bulovce

Praha 8 - Liben, 180 81, Czechia

Location

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

Teplice, 41501, Czechia

Location

Docrates Clinic

Helsinki, 00150, Finland

Location

Centre hospitalier Lyon Sud

Pierre-Bénite, 69495, France

Location

Praticien hospitalier

Tarbes, 65000, France

Location

RWTH Aachen Universität

Aachen, 52074, Germany

Location

Schmerz- und Palliativzentrum Göppingen

Göppingen, 73033, Germany

Location

St.-Marien-Hospital Lunen

Lünen, 44534, Germany

Location

Schmeiz - u Pallielivzendium Wiesbaden

Wiesbaden, 65189, Germany

Location

Yashoda Hospital

Andhra Pradesh, 500 082, India

Location

Bangalore Institute of Oncology

Bangalore, 560027, India

Location

CBCC- Apollo Hospital

Gandhinagar, India

Location

Apollo Hospital

Hyderabaad, 500033, India

Location

Indo-American Cancer Institute and Research Center

Hyderabaad, 500034, India

Location

Bhagwaan Mahaveer Cancer Hospital and Research Centre

Jaipur, 302017, India

Location

CHL - Apollo Hospitals

Madhya Pradesh, 452 008, India

Location

Jawaharlal Nehru Cancer Hospital

Madhya Pradesh, 462 001, India

Location

Meenakshi Mission Hospital & Research Centre

Madurai, 625107, India

Location

All India Institute of Medical Sciences

New Delhi, 110 029, India

Location

Jehangir Clinical Development Centre Pvt. Ltd.

Pune, 411001, India

Location

Deenanath Mangeshkar Hospital and Research Center

Pune, India

Location

Seroc Cancer Center

Rajasthan, 302 013, India

Location

Regina Elana Cancer Institute

Rome, 00144, Italy

Location

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

Turin, 10128, Italy

Location

Hospital Aranda de la Parra

León, 37000, Mexico

Location

Htal Ángeles de Pedregal

Mexico City, 10700, Mexico

Location

Beskidzkie Centrum Onkologii im. Jana Pawla

Bielsko-Biala, 43-300, Poland

Location

Poradnia Leczenia Bolu

Edyty Jakubow, Poland

Location

Wojewodzki Szpital Specjalistyczny im. M. Kopernika

Gdansk, 80-803, Poland

Location

NZOZ Hospicjum Milosierdzia Bozego

Gliwice, 44-101, Poland

Location

Szpital Uniwersytecki w Krakowie

Krakow, 31-631, Poland

Location

Wielkopolskie Centrum Onkologii

Poznan, 61-866, Poland

Location

Niepubliczny Zaklad Opieki Zdrowotnej

Tychy, 43-100, Poland

Location

Centrum Onkologii - Instytut im. M. Sklodowskiej - Curie

Warsaw, 02-781, Poland

Location

Spitalul Judetean de Urgenta "Constantin Opris"

Baia Mare, Maramures, 430031, Romania

Location

Spitalul Judetean de Urgenta Braila

Braila, Jud. Braila, 810325, Romania

Location

Hospice "Casa Sperantei"

Brasov, 500074, Romania

Location

Spitalul Universitar de Urgenta Elias

Bucharest, 011461, Romania

Location

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

Bucharest, 020962, Romania

Location

Policnica Orizont-Oncologie Medicala

Craiova, 200535, Romania

Location

District Hospital Dr. Alexandru Simionescu

Hunedoara, 331057, Romania

Location

Centrul de Oncologie Medicala

Iași, 700106, Romania

Location

Spitalul Municipal Onesti

Onesti, Jud. Bacau, 601048, Romania

Location

Spitalul Municipal Ploiesti

Ploieşti, 100337, Romania

Location

Spitalul Clinic Judetean Sibiu Oncologie

Sibiu, 550245, Romania

Location

Spitalul Judetean de Urgenta "Sf. Ioan cel Nou"

Suceava, 720237, Romania

Location

Medi Clinic

Bloemfontein, 9301, South Africa

Location

Pain Clinic

Cape Town, 8001, South Africa

Location

Dr. Pirjol & Szpak Inc.

eManzimtoti, 4126, South Africa

Location

Pretoria Urology Research Unit

Hatfield, Pretoria, 0083, South Africa

Location

Trialtech Research - Embassy Drive Medical Centre

Hatfield, Pretoria, 0083, South Africa

Location

Oncology/Haematology Dept Research Unit

Kimberley, 8301, South Africa

Location

Eastleigh Breast Cancer Center

Lynnwood, 0041, South Africa

Location

Hospital Virgen del Mar

Almería, 04003, Spain

Location

Hospital Universitario Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital Clinic i Provincial

Barcelona, 08036, Spain

Location

HU Puerta del Mar, Oncologia

Cadiz, 11009, Spain

Location

Hospital Universitario de Bellvitge

Feixa, Llarga, Sn, 08907, Spain

Location

Hospital Univ. Virgen de las Nieves

Granada, 180114, Spain

Location

Hospital de la Rioja

Logroño, 26001, Spain

Location

Hospital Los Montalvos

Salamanca, 37192, Spain

Location

Basingstoke & North Hampshire NHS Foundation Trust

Basingstoke, RG24 9NA, United Kingdom

Location

West Suffolk Hospital

Bury St Edmunds, IP33 2QZ, United Kingdom

Location

Fairfield General Hospital

Bury, Lancashire, BL9 7TD, United Kingdom

Location

Edinburgh Cancer Research Centre (CRUK)

Edinburgh, EH4 2XR, United Kingdom

Location

James Paget Hospital

Gorleston on Sea, Norfolk, NR31 6LA, United Kingdom

Location

International Observatory on End of Life Care

Lancaster, LA1 4YT, United Kingdom

Location

St Bartholomew's Hospital

London, EC1A 7BE, United Kingdom

Location

The Royal Marsden NHS Foundation Trust

London, SW3 6LL, United Kingdom

Location

Marie Curie Hospice Holme Tower

Penarth, CF64 3YR, United Kingdom

Location

The Royal Marsden NHS Foundation Trust

Sutton, SM2 5PT, United Kingdom

Location

Weston Area Health Trust

Weston-super-Mare, BS23 4TQ, United Kingdom

Location

New Cross Hospital

Wolverhampton, WV10 0QP, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 22483680 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: Matthew Hersch, Senior Clinical Project Manager
• Organization: GW Pharma Ltd.

mhersch@gwpham.com

+44 1353 616600

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2007
• First Posted: September 17, 2007
• Study Start: November 1, 2007
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: June 20, 2013
• Results First Posted: June 17, 2011

Record last verified: 2013-06

Locations

IT (2); BE (3); ME (2); ZA (7); FR (2); CL (2); US (23); CZ (9); DE (4); PL (8); GB (12); FI (1); RO (12); CA (2); IN (13); ES (8)