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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
73

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 31, 2016

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2018

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 22, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 1, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 5, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 18, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 16, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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