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Clinical Trials/CTRI/2020/12/029950
CTRI/2020/12/029950
Not yet recruiting
Phase 2

Sublingual Buprenorphine versus Oral immediate-release Morphine for Controlling Breakthrough pain in Cancer Patients referred to Specialist Palliative Care Services- A phase II Randomized Controlled Study

A0 sites0 target enrollmentTBD
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Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Not specified
Sponsor
A
Status
Not yet recruiting
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional

Investigators

Sponsor
A

Eligibility Criteria

Inclusion Criteria

  • •1\.Age \>18 years.
  • •2\.Cancer patients referred to or following up specialist palliative care services in the clinic or on home care.
  • •3\.History of breakthrough pain (as assessed by Davies Algorithm) and not taking rescue doses.
  • •4\.Patient receiving oral morphine for treatment of background pain.
  • •5\.Current prescribed oral morphine dose 60mg \- 180mg/day for background pain but not taking rescue doses for BTcP.
  • •6\.Patient at the time of screening visit experience his/her current BTcP episodes to be severe enough that he/she will require additional analgesia.
  • •7\.Willing to take part in the study
  • •8\.Patients residing in Mumbai for a period of 2 weeks after recruitment into study/baseline assessment.

Exclusion Criteria

  • •1\.Patients on opioid detoxification programme or Opioid Substitution Therapy
  • •2\.Patients on combination opioid therapy
  • •3\.Contra\-indications to buprenorphine ie. hypersensitivity to Buprenorphine

Outcomes

Primary Outcomes

Not specified

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