NCT04243954

Intravenous vs Oral Analgesia in Cancer Patients With Severe Pain After Successful Titration

Completed Phase 2 Last updated 5 March 2021

What this trial tests

Phase 2 trial testing PCA IV Hydromorphone (continuous dose = 0) in Cancer Pain in 95 participants. Completed in 21 November 2020.

Timeline

10 April 2020

Primary endpoint
21 October 2020

21 November 2020

Quick facts

Lead sponsor	Fujian Cancer Hospital
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	95
Start date	10 April 2020
Primary completion	21 October 2020
Estimated completion	21 November 2020
Sites	1 location across China

Drugs / interventions tested

• PCA IV Hydromorphone (continuous dose = 0) — full drug profile →
• PCA IV Hydromorphone (continuous dose ≠ 0)
• Oral morphine

Conditions studied

• Cancer Pain — all drugs for Cancer Pain →

Sponsor

Fujian Cancer Hospital

Who can join

Adults 18 to 80, any sex, with Cancer Pain. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Pain is one of the most common and fear symptoms for cancer patients, which seriously affects the quality of life in cancer patients. At present, oral opioid is the most common route to administrate cancer pain. However, the patients do not satisfy the pain administration with oral opioid after successful titration in many cases, especially the cases with severe cancer pain. Patient controlled analgesia (PCA) with hydromorphone can take analgesic effect rapidly. The aim of this trial is to compare the maintenance with hydromorphone PCA intravenously or switch to Sustained-Release Morphine orally after successful titraton with hydromorphone PCA intravenously in severe cancer pain.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Hydromorphone for cancer pain.
   Li Y, Ma J, Lu G, Dou Z, et al · · 2021 · cited 14× · PMID 34350974 · DOI 10.1002/14651858.cd011108.pub3