CompletedPhase 4

Study Evaluating Safety and Tolerability of Oxycodone in Patients With Moderate to Severe Cancer Pain

Taiwan73 participantsStarted 2016-10-31

Plain-language summary

This study is to evaluate the safety and tolerability of oxycodone control-released (CR) and/or immediate-released (IR) use in patients with moderate to severe cancer pain in a 3-months period in Taiwan.

Who can participate

Age range

20 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Cancer patients aged 20 years old and over
. ECOG ≤ 2
. Moderate to severe pain intensity (NRS pain score ≥ 4)
. Cancer-related pain that requires treatment with continuous around-the-clock strong opioid analgesic
. Patients who will not be treated with radiotherapy within 7 days prior to screening and during study
. Patients or his/her caregivers who are able to fill out the questionnaire forms
. Patient provided signed informed consent

Exclusion criteria

. Patients diagnosed with non-cancer pain or unexplained pain
. Patients who cannot be applicable for oral administration
. Patients who have constipation (CTCAE grade 3 and above)
. Patients with evidence of significant structural/functional abnormalities of GI tract or planned to undergo surgeries that have high risk lead to gastrointestinal stenosis, blind loop or gastrointestinal obstruction during study

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number and percentage of patients with adverse events (AEs) and serious adverse events (SAEs)

Timeframe: Up to 14 weeks

Trial details

NCT IDNCT03176121

SponsorTaiwan Mundipharma Pharmaceuticals Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-12-31

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