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Study of CBME in the Relief of Painful Diabetic Neuropathy

NCT00238550 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2022-06-13

No results posted yet for this study

Summary

The study is designed to investigate the benefit of adding CBME to the existing treatment regime in the management of painful neuropathy.

Hypothesis:

1. The addition of CBME to the existing treatment regime will result in a significant improvement in both primary and secondary outcome measures.
2. The side effect profile and tolerability of CBME will be minimal and comparable to placebo.

Conditions

  • Diabetic Neuropathy
  • Painful

Interventions

DRUG

Cannabis based medicine extract (CBME)

Sponsors & Collaborators

  • Diabetes UK

    collaborator OTHER

  • Sheffield Teaching Hospitals NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Solomon Tesfaye · Sheffield Teaching Hosiptals NHS Foundation Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-10-31
Completion
2006-03-31

Countries

  • United Kingdom

Study Locations

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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 NCT00238550 on ClinicalTrials.gov