Phase 2
Completed N=360
A Study of Sativex® for Pain Relief in Patients With Advanced Malignancy.
Source: ClinicalTrials.gov NCT00530764 ↗Enrolled (actual)
360
Serious AEs
29.0%
Results posted
Jun 2011
Primary outcomePrimary: Number of Patients With at Least 30% Improvement in Numerical Rating Scale (NRS) Average Pain Score From Baseline — 22; 26; 30; 24 Participants — p=0.33
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With at Least 30% Improvement in Numerical Rating Scale (NRS) Average Pain Score From Baseline |
22; 26; 30; 24 | 0.33 |
| SECONDARY Change in Cumulative Average Pain Response Curves |
-13; -20; -20; -10 | 0.0077 sig |
| SECONDARY Change in Mean Daily NRS Pain Score (Average Pain). |
-0.9; -1.2; -1.6; -0.8 | 0.006 sig |
| SECONDARY Change in Mean Daily NRS Pain Score (Worst Pain). |
-1.0; -1.2; -1.6; -0.9 | 0.011 sig |
| SECONDARY Change in Sleep Disruption NRS |
-0.7; -0.9; -1.5; -0.8 | 0.003 sig |
| SECONDARY Change in Brief Pain Inventory - Short Form (BPI-SF) |
-1.0; -1.5; -1.3; -1.0 | — |
| SECONDARY Change in Patient Assessment of Constipation Quality of Life (PAC-QoL) |
0.0; -0.1; 0.0; -0.1 | — |
| SECONDARY Change in Patient Global Impression of Change - PGIC |
6; 6; 10; 9; 20; 19 | — |
| SECONDARY Change in Montgomery Asberg Depression Rating Scale (MADRS) |
-0.4; -1.0; -1.1; -2.9 | — |
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.
Data sourced from ClinicalTrials.gov (NCT00530764). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.