Study of Opioid Rotation Versus Opioid Escalation in Patients With Moderate to Severe Cancer Pain

Pain Clinical Trial

Official title:

Efficacy and Safety of Opioid Rotation Compared With Opioid Dose Escalation in Patients With Moderate to Severe Cancer Pain - Open Label, Randomized, Prospective Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02084355
• Other study ID #: GNUH-2013-07-014
• Status: Not yet recruiting
• Phase: Phase 3
• First received: March 5, 2014
• Last updated: March 7, 2014
• Start date: April 2014
• Est. completion date: January 2016

Study information

• Verified date: March 2014
• Source: Gyeongsang National University Hospital
• Contact: Se-Il Go, M.D.
• Phone: +82 55 750 9454
• Email: gose1[@]hanmail.net
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Although opioid rotation is well known treatment modality in reducing pain and opioid-induced neurotoxicity, it is not established whether opioid rotation is more appropriate or opioid escalation is more effective in controlling significant pain in cancer patients under opioid medication.

• The purpose of this study is to determine effective therapy out of opioid rotation and opioid dose escalation in patients with moderate to severe cancer pain who have been already treated with strong opioid.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 136
• Est. completion date: January 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• age > 18 years

• patients who are being treated with one of strong opioids including oral oxycodone, oral hydromorphone, or fentanyl patch with range from 60 mg to 200 mg of oral morphine equivalent daily dose (MEDD)

• moderate to severe cancer pain (numeric rating scale more than 3) at screening

• patients without uncontrolled adverse effects associated with currently applied opioid

Exclusion Criteria:

• previous opioid rotation

• unable to take oral medication

• life expectancy less than a month

• newly started chemotherapy and/or radiotherapy within past 2 weeks of screening

• serum aspartate aminotransferase, alanine aminotransferase, or alkaline phosphatase > 2.5 times of upper normal limit

• serum total bilirubin or creatinine > 1.5 times of upper normal limit

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Cancer
• Pain

Intervention

Drug:
• oral oxycodone

• oral hydromorphone

• fentanyl patch

Locations

Country	Name	City	State
Korea, Republic of	Gyeongsang National University Hospital	Jinju	Gyeongsangnam-do

Sponsors (1)

Lead Sponsor	Collaborator
Gyeongsang National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The rate of successful pain control defined as a 30% or 2-point reduction in the numeric rating scale		Eighteen months	Yes