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

March 16, 2020 updated by: Taiwan Mundipharma Pharmaceuticals Ltd.

A Long Term, Open-Label, Multi-Center Study Evaluating Safety and Tolerability of Oxycodone in Patients With Moderate to Severe Cancer Pain

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is an open label, long-term study carrying in multi-centers. Around 200 patients with moderate to severe cancer pain (NRS ≥ 4) who agreed and signed informed consent will be enrolled to receive oxycodone with continuous around-the-clock pattern. The study is to evaluate the safety and tolerability of cancer patients who receive CR and/or IR oxycodone. The number and percentage of patients with adverse events and serious adverse events will be recorded throughout the study.

The study will continue for 3 months to observe the safety and tolerability. After screening at Screening visit, patients begin the study by the first day visit (Day 1). Pain assessment, study related questionnaires are giving out to measure the baseline scale of each patient. Questionnaires including rate of quality of analgesia, EQ-5D and clinical opiate withdrawal scale (COWS). The prescription of the study drug will be recorded from Day 1. Patients will need to visit bi-weekly, including Wk 2 (Day 14±3), Wk 4 (Day 28±3), Wk 6 (Day 42±3), Wk 8 (Day 56±3), Wk 10 (Day 70±3) and Wk 12 (Day 84±3). Pain assessment will be assessed in each visit, drug accountability will be recorded accordingly. The rate of quality of Analgesia will be assessed in each visit; QoL (EQ-5D) will be recorded in Wk 4, Wk 8 and Wk 12. The COWS will be assessed again in Wk 12.

The safety for individual patient will be followed during study up to 2 weeks after the end of treatment (EOT) or early termination (ET). The telephone contact for safety follow-up is acceptable for this study.

Study Type

Interventional

Enrollment (Actual)

73

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Chang-hua, Taiwan, 500
        • Changhua Christian Hospital
      • Chiayi City, Taiwan
        • Chang Gung Memorial Hospital, Chiayi Branch
      • Kaohsiung, Taiwan, 83301
        • Chang gung memorial hospital, Kaohsiung branch
      • Keelung, Taiwan, 204
        • Chang Gung Memorial Hospital, Keelung Branch
      • Taichung, Taiwan, 40447
        • China Medical University Hospital
      • Taichung, Taiwan
        • Taichung Veterans General Hospital
      • Taipei, Taiwan, 10449
        • Mackay Memorial Hospital
      • Taipei, Taiwan, 114
        • Tri-Service General Hospital
      • Taipei, Taiwan, 111
        • Shin Kong Wu Ho-Su Memorial Hospital
      • Taoyuan City, Taiwan, 333
        • Chang Gung Memorial Hospital, Linkou Branch

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. Patients diagnosed with non-cancer pain or unexplained pain
  2. Patients who cannot be applicable for oral administration
  3. Patients who have constipation (CTCAE grade 3 and above)
  4. 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
  5. Abnormal lab results, with obvious clinical significance, such as the creatinine ≥ 2 fold of upper limit of normal value, or ALT or AST ≥ 2.5 fold of upper limit of normal value (≥ 5 fold, to the patients with liver metastasis or primary liver cancer), or liver function of Child C grade prior to study
  6. Pregnant or nursing (lactating) women
  7. Patients who are drug or alcohol abuse
  8. Patients with moderate to severe psychiatric problems
  9. Patients who have hypersensitivity to oxycodone
  10. Patients who are clinically unstable or have a life expectancy of less than three months making completion of the trial unlikely

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Oxycodone treatment

Patients will take either control-released oxycodone (OxyContin® 10mg and 20mg) or immediate-released oxycodone (OxyNorm® 5mg) or both for initial dose and used it to titrate his/her background dose.

After regular time assessment of the pain score (NRS), if the pain control is inadequate (NRS ≥ 4), a total daily dose in 24hrs will be summed up for the next dose titration until reach a stable dose (as defined as total daily dose is fixed for at least two weeks).
Drug: Oxycodone
Patients will take either CR oxycodone or IR oxycodone or both for initial dose and used it to titrate his/her background dose.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number and percentage of patients with adverse events (AEs) and serious adverse events (SAEs)
Time Frame: Up to 14 weeks
Number and percentage of patients with adverse events (AEs) and serious adverse events (SAEs)
Up to 14 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline pain intensity scale (NRS)
Time Frame: Up to 12 weeks
The change from baseline pain intensity scale (NRS) to each visit
Up to 12 weeks
Time (days) needs in first titration to a stable dose
Time Frame: Up to 12 weeks
The time (days) needs in first stable titration
Up to 12 weeks
Average dosage (mg/day) needs in first titration to a stable dose
Time Frame: Up to 12 weeks
The average dosage needs in first stable titration
Up to 12 weeks
Quality of analgesia using rating of excellent, very good, good, fair or poor
Time Frame: Up to 12 weeks
The percentage of patients rating quality of analgesia of excellent, very good, good, fair or poor
Up to 12 weeks
Treatment discontinuation reason (due to AE, withdraw consent, or any kinds of reasons)
Time Frame: Up to 12 weeks
Analysis treatment discontinue reason (due to AE, withdraw consent, or any kinds of reasons)
Up to 12 weeks
Change from baseline in QoL questionnaire (EQ-5D)
Time Frame: Up to 12 weeks
The change from baseline in QoL questionnaire (EQ-5D)
Up to 12 weeks
Opiate withdrawal level by Clinical Opiate Withdrawal Scale (COWS)
Time Frame: Up to 12 weeks
The change of clinical opiate withdrawal scale (COWS) from baseline
Up to 12 weeks
Safety and tolerability (PE and vital sign change from baseline)
Time Frame: Up to 14 weeks
The change from baseline in PE and vital sign
Up to 14 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taiwan Mundipharma Pharmaceuticals Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 31, 2016

Primary Completion (ACTUAL)

December 31, 2018

Study Completion (ACTUAL)

December 31, 2018

Study Registration Dates

First Submitted

May 22, 2017

First Submitted That Met QC Criteria

June 1, 2017

First Posted (ACTUAL)

June 5, 2017

Study Record Updates

Last Update Posted (ACTUAL)

March 18, 2020

Last Update Submitted That Met QC Criteria

March 16, 2020

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OXY16-TW-401

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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