A Double Blind, Randomized, Parallel Group, Placebo Controlled, Comparative Study of the Efficacy, Safety and Tolerability of Cannabis Based Medicine (CBM) Extracts in Patients With Cancer-related Pain. (SPRAY)

NCT00674609 Phase 3 COMPLETED Results posted

The purpose of this study is to determine whether Sativex® and GW-2000-02 are effective in the management of subjects with intractable cancer-related pain.

Details

Lead sponsor	Jazz Pharmaceuticals
Phase	Phase 3
Status	COMPLETED
Enrolment	177
Start date	2002-02
Completion	2004-03

Conditions

• Palliative Care
• Pain
• Cancer

Interventions

• Placebo
• Sativex®
• THC Alone

Primary outcomes

• The Change in Mean Pain Numerical Rating Scale (NRS) Score From Baseline to the End of the Treatment. — 2 weeks: baseline - end of week 2 (last 3 days of treatment)
  The 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.
• The Consumption of Escape Analgesic Medication. — 2 weeks: baseline - end of week 2 (last 3 days of treatment)
  Subjects recorded their use of escape medication each day on their diary card.

Countries

United Kingdom