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Sativex® for Relieving Persistent Pain in Patients With Advanced Cancer

NCT01361607 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 399

Last updated 2023-04-12

Study results available
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Summary

This 9-week study aimed to determine the efficacy, safety, and tolerability of nabiximols (Sativex®) as an adjunctive treatment, compared with placebo in relieving uncontrolled persistent chronic pain in participants with advanced cancer.

Eligible participants were not required to stop any of their current treatments or medications.

Conditions

Interventions

DRUG

Nabiximols

DRUG

Placebo (GA-0034)

Sponsors & Collaborators

  • Otsuka Pharmaceutical Development & Commercialization, Inc.

    collaborator INDUSTRY

  • Jazz Pharmaceuticals

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-05-27
Primary Completion
2014-11-24
Completion
2014-11-24

Countries

  • United States
  • Bulgaria
  • Czechia
  • Germany
  • Hungary
  • Mexico
  • Poland
  • Puerto Rico
  • Romania
  • United Kingdom

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01361607 on ClinicalTrials.gov