| September 13, 2007 |
| October 31, 2009 |
| November 2007 |
| October 2009 (final data collection date for primary outcome measure) |
| The primary outcome measure is the IVRS 11-point Numeric Rating Scale pain score (average pain). |
| The primary outcome measure is the IVRS 11-point Numeric Rating Scale pain score (average pain) during the last three days of week 5. |
| Complete list of historical versions of study NCT00530764 on ClinicalTrials.gov Archive Site |
- Cumulative average pain response curves
- Mean daily IVRS NRS pain score (average and also worst pain).
- Brief Pain Inventory - Short Form
- Sleep Disruption NRS
- Patient Assessment of Constipation Quality of Life (PAC-QoL)
- Patient Global Impression of Change - PGIC
- Montgomery Asberg Depression Rating Scale (MADRS)
- Addiction Research Center Inventory (ARCI)
|
| Same as current |
| |
| A Study of Sativex® for Pain Relief in Patients With Advanced Malignancy. |
| 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. |
| |
| Phase II |
| Interventional |
| Supportive Care, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment |
- Palliative Care
- Pain
- Cancer
|
| Drug: GW-1000-02 |
| |
| |
| |
| Active, not recruiting |
| 336 |
| November 2009 |
| October 2009 (final data collection date for primary outcome measure) |
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 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.
|
| Both |
| 18 Years and older |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States, Belgium, Canada, Chile, Czech Republic, Finland, France, Germany, India, Italy, Mexico, Poland, Romania, South Africa, Spain, United Kingdom |
| |
| NCT00530764 |
| Clinical Project Manager, GW Pharmaceuticals Ltd |
| GWCA0701 |
| GW Pharmaceuticals Ltd. |
| Quintiles |
|
| GW Pharmaceuticals Ltd. |
| February 2009 |