Clinical trial NCT00530764: A Study of Sativex® for Pain Relief in Patients With Advanced Malignancy.
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Palliative Care
Pain
Cancer
Keywords: Pain
Cancer
Palliative
Lead sponsor: GWPharm
Sponsor class: UNKNOWN
Collaborators: name: Quintiles, Inc.
First posted: 2007-09-17
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Number of Patients With at Least 30% Improvement in Numerical Rating Scale (NRS) Average Pain Score From Baseline
timeFrame: 5 Weeks: Baseline (first 3 days) - Week 5 (last 3 days)
Secondary outcomes:
measure: Change in Cumulative Average Pain Response Curves
timeFrame: Baseline to end of treatment (Week 5)
measure: Change in Mean Daily NRS Pain Score (Average Pain).
timeFrame: 5 Weeks: Baseline (first 3 days) - End of Treatment (last 3 days of week 5)
measure: Change in Mean Daily NRS Pain Score (Worst Pain).
timeFrame: 5 Weeks: Baseline (first 3 days) - End of Treatment (last 3 days of week 5)
measure: Change in Sleep Disruption NRS
timeFrame: 5 Weeks: Baseline - End of Treatment (Last 3 days of Week 5)
measure: Change in Brief Pain Inventory - Short Form (BPI-SF)
timeFrame: Baseline (Visit 2) and End of Treatment (End of Week 5 or premature termination)
measure: Change in Patient Assessment of Constipation Quality of Life (PAC-QoL)
timeFrame: Baseline (Visit 2) and End of Treatment (Week 5 or premature termination)
measure: Change in Patient Global Impression of Change - PGIC
timeFrame: End of Week 5
measure: Change in Montgomery Asberg Depression Rating Scale (MADRS)
timeFrame: Baseline and End of Treatment (Week 5 or premature termination)
Other outcomes:
Locations:
city: Tuscaloosa
country: United States
facility: Cancer Care Center of Tuscaloosa
state: Alabama
city: Casa Grande
country: United States
facility: Desert Oasis Cancer Center
state: Arizona
city: Fountain Valley
country: United States
facility: Pacific Coast Hematology/Oncology Medical Group, Inc.
state: California
city: Gilroy
country: United States
facility: Office of Dr. Ronald Yanagihara
state: California
city: La Jolla
country: United States
facility: University of California San Diego
state: California
city: Loma Linda
country: United States
facility: Loma Linda University
state: California
city: Jacksonville
country: United States
facility: Florida Institute of Medical Research
state: Florida
city: Tampa
country: United States
facility: Clinical Pharmacology Services
state: Florida
city: Riverdale
country: United States
facility: Center of Hope for Cancer and Blood Disorders
state: Georgia
city: New Orleans
country: United States
facility: Louisiana Research Associates
state: Louisiana
city: Hagerstown
country: United States
facility: The Center for Clinical Research - Washington County Hospital
state: Maryland
city: Jefferson City
country: United States
facility: Capital Comprehensive Cancer Care Clinic
state: Missouri
city: St. Louis
country: United States
facility: A & A Pain Institute of St. Louis
state: Missouri
city: Great Falls
country: United States
facility: Office of Donald H. Berdeaux MD
state: Montana
city: Berkeley Heights
country: United States
facility: Summit Medical Group
state: New Jersey
city: New York
country: United States
facility: Beth Israel Medical Center
state: New York
city: New York
country: United States
facility: Metropolitan Hospital Center
state: New York
city: Flat Rock
country: United States
facility: Four Seasons Hospice & Pallative Care
state: North Carolina
city: Winston-Salem
country: United States
facility: Center for Clinical Research
state: North Carolina
city: Canton
country: United States
facility: Gabrail Cancer Center
state: Ohio
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center
state: Tennessee
city: Austin
country: United States
facility: Lone Star Oncology
state: Texas
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute
state: Utah
city: Bruxelles
country: Belgium
facility: Jules Bordet Institute
city: Charleroi
country: Belgium
facility: CHU Charleroi (Hôpital civil de Charleroi)
city: Pellenberg
country: Belgium
facility: UZ Leuven - Algologisch Centrum Anesthesiologie
city: Victoria
country: Canada
facility: Vancouver Health Research Center
state: British Columbia
city: Montreal
country: Canada
facility: Jewish General Hospital
state: Quebec
city: Santiago
country: Chile
facility: Instituto Radio-oncológico Santiago (INRAD)
city: Viña del Mar
country: Chile
facility: Clínica Ciudad del Mar
city: Benešov
country: Czech Republic
facility: Ambulance pro lécbu bolesti, ARO
city: Ceské Budejovice
country: Czech Republic
facility: Ambulance pro lécbu bolesti
city: Ceské Budejovice
country: Czech Republic
facility: Nemocnice Ceské Budejovice
city: Hradec Králové
country: Czech Republic
facility: FN Hradec Králové - Klinika onkologie a radioterapie
city: Jihlava
country: Czech Republic
facility: Nemocnice Jihlava
city: Olomouc
country: Czech Republic
facility: FN a LF UP Olomouc - Ambulance pro lécbu bolesti
city: Plzen
country: Czech Republic
facility: AR klinika FN Plzen -Ambulance pro lécbu bolesti
city: Praha 8 - Liben
country: Czech Republic
facility: Fakultní nemocnice Na Bulovce
city: Teplice
country: Czech Republic
facility: ARO, Krajská zdravotni, K.Z. a.s, Nemocnice
city: Helsinki
country: Finland
facility: Docrates Clinic
city: Pierre-Benite
country: France
facility: Centre hospitalier Lyon Sud
city: Tarbes
country: France
facility: Praticien hospitalier
city: Aachen
country: Germany
facility: RWTH Aachen Universität
city: Göppingen
country: Germany
facility: Schmerz- und Palliativzentrum Göppingen
city: Lunen
country: Germany
facility: St.-Marien-Hospital Lunen
city: Wiesbaden
country: Germany
facility: Schmeiz - u Pallielivzendium Wiesbaden
city: Andhra Pradesh
country: India
facility: Yashoda Hospital
city: Bangalore,
country: India
facility: Bangalore Institute of Oncology
city: Gandhinagar
country: India
facility: CBCC- Apollo Hospital
city: Hyderabaad
country: India
facility: Apollo Hospital
city: Hyderabaad
country: India
facility: Indo-American Cancer Institute and Research Center
city: Jaipur
country: India
facility: Bhagwaan Mahaveer Cancer Hospital and Research Centre
city: Madhya Pradesh
country: India
facility: CHL - Apollo Hospitals
city: Madhya Pradesh
country: India
facility: Jawaharlal Nehru Cancer Hospital
city: Madurai
country: India
facility: Meenakshi Mission Hospital & Research Centre
city: New Delhi
country: India
facility: All India Institute of Medical Sciences
city: Pune
country: India
facility: Jehangir Clinical Development Centre Pvt. Ltd.
city: Pune
country: India
facility: Deenanath Mangeshkar Hospital and Research Center
city: Rajasthan
country: India
facility: Seroc Cancer Center
city: Rom
country: Italy
facility: Regina Elana Cancer Institute
city: Turin
country: Italy
facility: Dir. S.C.D.U. Psicologia Clinica ed Oncologica
city: Leon
country: Mexico
facility: Hospital Aranda de la Parra
city: Mexico DF
country: Mexico
facility: Htal Ángeles de Pedregal
city: Bielsko-Biala
country: Poland
facility: Beskidzkie Centrum Onkologii im. Jana Pawla
city: Edyty Jakubow
country: Poland
facility: Poradnia Leczenia Bolu
city: Gdansk
country: Poland
facility: Wojewodzki Szpital Specjalistyczny im. M. Kopernika
city: Gliwice
country: Poland
facility: NZOZ Hospicjum Milosierdzia Bozego
city: Krakow
country: Poland
facility: Szpital Uniwersytecki w Krakowie
city: Poznan
country: Poland
facility: Wielkopolskie Centrum Onkologii
city: Tychy
country: Poland
facility: Niepubliczny Zaklad Opieki Zdrowotnej
city: Warszawa
country: Poland
facility: Centrum Onkologii - Instytut im. M. Sklodowskiej - Curie
city: Baia Mare, Maramures
country: Romania
facility: Spitalul Judetean de Urgenta "Constantin Opris"
city: Braila, Jud. Braila
country: Romania
facility: Spitalul Judetean de Urgenta Braila
city: Brasov
country: Romania
facility: Hospice "Casa Sperantei"
city: Bucuresti
country: Romania
facility: Spitalul Universitar de Urgenta Elias
city: Bucuresti
country: Romania
facility: S.C. IanuliMed S.R.L. Oncologie Medicala
city: Craiova
country: Romania
facility: Policnica Orizont-Oncologie Medicala
city: Hunedoara
country: Romania
facility: District Hospital Dr. Alexandru Simionescu
city: Iasi
country: Romania
facility: Centrul de Oncologie Medicala
city: Onesti, Jud. Bacau
country: Romania
facility: Spitalul Municipal Onesti
city: Ploiesti
country: Romania
facility: Spitalul Municipal Ploiesti
city: Sibiu
country: Romania
facility: Spitalul Clinic Judetean Sibiu Oncologie
city: Suceava
country: Romania
facility: Spitalul Judetean de Urgenta "Sf. Ioan cel Nou"
city: Amanzimtoti
country: South Africa
facility: Dr. Pirjol & Szpak Inc.
city: Bloemfontein
country: South Africa
facility: Medi Clinic
city: Cape Town
country: South Africa
facility: Pain Clinic
city: Hatfield, Pretoria
country: South Africa
facility: Pretoria Urology Research Unit
city: Hatfield, Pretoria
country: South Africa
facility: Trialtech Research - Embassy Drive Medical Centre
city: Kimberley
country: South Africa
facility: Oncology/Haematology Dept Research Unit
city: Lynnwood
country: South Africa
facility: Eastleigh Breast Cancer Center
city: Almeria
country: Spain
facility: Hospital Virgen del Mar
city: Barcelona
country: Spain
facility: Hospital Universitario Vall d'Hebron
city: Barcelona
country: Spain
facility: Hospital Clinic i Provincial
city: Cadiz
country: Spain
facility: HU Puerta del Mar, Oncologia
city: Feixa, Llarga, sn
country: Spain
facility: Hospital Universitario de Bellvitge
city: Granada
country: Spain
facility: Hospital Univ. Virgen de las Nieves
city: Logrono
country: Spain
facility: Hospital de la Rioja
city: Salamanca
country: Spain
facility: Hospital Los Montalvos
city: Basingstoke
country: United Kingdom
facility: Basingstoke & North Hampshire NHS Foundation Trust
city: Bury St Edmunds
country: United Kingdom
facility: West Suffolk Hospital
city: Bury, Lancashire
country: United Kingdom
facility: Fairfield General Hospital
city: Edinburgh
country: United Kingdom
facility: Edinburgh Cancer Research Centre (CRUK)
city: Gorleston on Sea, Norfolk
country: United Kingdom
facility: James Paget Hospital
city: Lancaster
country: United Kingdom
facility: International Observatory on End of Life Care
city: London
country: United Kingdom
facility: St Bartholomew's Hospital
city: London
country: United Kingdom
facility: The Royal Marsden NHS Foundation Trust
city: Penarth
country: United Kingdom
facility: Marie Curie Hospice Holme Tower
city: Sutton
country: United Kingdom
facility: The Royal Marsden NHS Foundation Trust
city: Weston super Mare
country: United Kingdom
facility: Weston Area Health Trust
city: Wolverhampton
country: United Kingdom
facility: New Cross Hospital
Study officials:
References:
citation: 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.