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Clinical Trials/ACTRN12619001013156
ACTRN12619001013156
Completed
Phase 1

An open label study to evaluate the safety, tolerability, and pharmacokinetics of a medicinal cannabinoid oil formulation in chronic non-cancer pain patients

Zelda Therapeutics0 sites9 target enrollmentJuly 15, 2019
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Conditionschronic painAnaesthesiology - Pain management

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
chronic pain
Sponsor
Zelda Therapeutics
Enrollment
9
Status
Completed
Last Updated
5 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
July 15, 2019
End Date
April 9, 2020
Last Updated
5 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Zelda Therapeutics

Eligibility Criteria

Inclusion Criteria

  • •Chronic non\-cancer pain on long term treatment (\>12months) with high dose (OMEDD \>60mg) opioid analgesia.
  • •Willing to cease driving a motor vehicle for the duration of the study.
  • •No cannabis use in the last month.

Exclusion Criteria

  • •Dependence on cannabis.
  • •Cardiovascular disorder, epilepsy, psychosis, bipolar disorder, 1st degree relative with psychosis.
  • •Dependence on alcohol, benzodiazepines, or amphetamine type stimulants.
  • •Evidence of severe hepatic/renal impairment.
  • •Active malignancy.
  • •Females who are pregnant, lactating or not using adequate contraception.
  • •Males who are not using adequate contraception.

Outcomes

Primary Outcomes

Not specified

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