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A Study of Sativex® for Pain Relief Due to Diabetic Neuropathy

NCT00710424 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 297

Last updated 2023-05-03

Study results available
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Summary

The purpose of this study is to evaluate the efficacy of Sativex® compared with placebo in relieving pain due to Diabetic Neuropathy.

Conditions

  • Pain
  • Diabetic Neuropathy

Interventions

DRUG

Sativex

containing THC (27 mg/ml):CBD (25 mg/ml), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavouring. Maximum permitted dose was eight actuations in any three hour period and 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours

DRUG

Placebo

containing peppermint oil, 0.05% (v/v), quinoline yellow, 0.005% (w/v), sunset yellow, 0.0025% (w/v), in ethanol:propylene glycol (50:50) excipient.

Sponsors & Collaborators

Principal Investigators

  • Solomon Tesfaye, JCHMT FRCP · Royal Hallamshire Hospital

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-07-31
Primary Completion
2006-06-30
Completion
2006-06-30

Countries

  • United Kingdom

Study Locations

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Entities

Drugs
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 NCT00710424 on ClinicalTrials.gov