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

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ClinicalTrials.gov Identifier: NCT03176121
Recruitment Status : Recruiting
First Posted : June 5, 2017
Last Update Posted : June 5, 2017
Sponsor:
Information provided by (Responsible Party):
Taiwan Mundipharma Pharmaceuticals Ltd.

Brief 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.

Condition or disease Intervention/treatment Phase
Cancer Pain Drug: Oxycodone Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Long Term, Open-Label, Multi-Center Study Evaluating Safety and Tolerability of Oxycodone in Patients With Moderate to Severe Cancer Pain
Actual Study Start Date : October 31, 2016
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Change from baseline pain intensity scale (NRS) [ Time Frame: Up to 12 weeks ]
    The change from baseline pain intensity scale (NRS) to each visit

  2. Time (days) needs in first titration to a stable dose [ Time Frame: Up to 12 weeks ]
    The time (days) needs in first stable titration

  3. 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

  4. 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

  5. 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)

  6. Change from baseline in QoL questionnaire (EQ-5D) [ Time Frame: Up to 12 weeks ]
    The change from baseline in QoL questionnaire (EQ-5D)

  7. 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

  8. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03176121


Contacts
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Contact: Brook Chung, MSc 886-2-87297521 brook.chung@mundipharma.com.tw

Locations
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Taiwan
Changhua Christian Hospital Recruiting
Chang-hua, Taiwan, 500
Contact: Ming-Lin Ho, PhD    886-975-786-818    Drho123@gmail.com   
Principal Investigator: Ming-Lin Ho, PhD         
Sub-Investigator: Pei-Yu Tsai, MD         
Sub-Investigator: Hsuan-Yu Lin, MD         
Sub-Investigator: Chih-Yuan Chung, MD         
Sub-Investigator: Guan-Min Lai, MD         
Chang Gung Memorial Hospital, Chiayi branch Recruiting
Chiayi County, Taiwan
Contact: Wen-Shih Huang, PhD    886-5-3621000 ext 2862    WSHuang77@hotmail.com   
Principal Investigator: Wen-Shih Huang, PhD         
Sub-Investigator: Chih-Chien Chin, MD         
Sub-Investigator: Yi-Hung Kuo, MD         
Sub-Investigator: Meng-Chiao Hsieh, MD         
Sub-Investigator: Cheng-Yi Huang, MD         
Sub-Investigator: Chih-Jung Chen, MD         
Sub-Investigator: Tsan-Hung Lee, MD         
Sub-Investigator: Feng-Che Kuan, MD         
Chang Gung Memorial Hospital, Kaohsiung branch Recruiting
Kaohsiung, Taiwan, 83301
Contact: Chien-Chang Lu, MD    886-7-7317123 ext 8008    cclu999@gmail.com   
Principal Investigator: Chien-Chang Lu, MD         
Sub-Investigator: Hong-Hwa Chen, MD         
Sub-Investigator: Chia-Lo Chang, MD         
Sub-Investigator: Wang-Hseng Hu, MD         
Sub-Investigator: Ko-Chao Lee, MD         
Sub-Investigator: Kai-Lung Tsai, MD         
Sub-Investigator: Yueh-Ming Lin, MD         
Sub-Investigator: Yu-Li Su, MD         
Sub-Investigator: Tai-Jan Chiu, MD         
Sub-Investigator: Eng-Yen Huang, MD         
Sub-Investigator: Hsuan-Chih Hsu, MD         
Chang Gung Memorial Hospital, Keelung branch Recruiting
Keelung, Taiwan, 204
Contact: Wen-Ko Tseng, MD    886-24313131 ext 2624    tsangwen@cgmh.org.tw   
Principal Investigator: Wen-Ko Tseng, MD         
Sub-Investigator: Chung-Wei Fan, MD         
China Medical University Hospital Recruiting
Taichung, Taiwan, 40447
Contact: Liang-Chih Liu, PhD    886-4-22052121 ext 1639    dr0363@yahoo.com.tw   
Principal Investigator: Liang-Chih Liu, PhD         
Sub-Investigator: Hwei-Chung Wang, MD         
Sub-Investigator: Chih-Jung Chen, MD         
Sub-Investigator: Yao-Chung Wu, MD         
Taichung Veterans General Hospital Recruiting
Taichung, Taiwan
Contact: Jin-Ching Lin, PhD    886-4-23592525 ext 5613    jclin@mail.vghtc.gov.tw   
Principal Investigator: Jin-Ching Lin, PhD         
Principal Investigator: Wen-Li Hwang, MD         
Sub-Investigator: Jin-Wei Lin, MD         
Sub-Investigator: Chieh-Lin Teng, PhD         
Sub-Investigator: Shao-Min Han, MD         
Sub-Investigator: Yi-Chun Liu, MD         
MacKay Memorial Hospital Recruiting
Taipei, Taiwan, 10449
Contact: Yi-Fang Chang, PhD    886-2-25433535 ext 3455    changyifang@gmail.com   
Principal Investigator: Yi-Fang Chang, PhD         
Sub-Investigator: Caleb Gon-Shen Chen, PhD         
Sub-Investigator: Johnson Lin, MPH         
Sub-Investigator: Ken-Hong Lin, MD         
Sub-Investigator: Yu-Cheng Chang, MD         
Shin Kong Wu Ho-Su Memorial Hospital Recruiting
Taipei, Taiwan, 111
Contact: Chia-Mo Lin, MD    886-2-28332211 ext 2030    M002178@ms.skh.org.tw   
Principal Investigator: Chia-Mo Lin, MD         
Sub-Investigator: Diana Yu-Wung Yeh, MD         
Sub-Investigator: Shang-Jyh Kao, MD         
Sub-Investigator: Jiunn-Song Jiang, MD         
Tri-Service General Hospital Recruiting
Taipei, Taiwan, 114
Contact: Ching-Liang Ho, MD    886-2-87927208    hochingliang@yahoo.com.tw   
Principal Investigator: Ching-Liang Ho, MD         
Chang Gung Memorial Hospital, LinKou branch Recruiting
Taoyuan City, Taiwan, 333
Contact: Jinn-Shiun Chen, MD    886-3-3281200 ext 2101    chenjs@adm.cgmh.org.tw   
Principal Investigator: Jinn-Shiun Chen, MD         
Sub-Investigator: Rei-Ping Tang, MD         
Sub-Investigator: Yau-Tong You, MD         
Sub-Investigator: Jy-Ming Chiang, MD         
Sub-Investigator: Pao-Shiu Hsieh, MD         
Sub-Investigator: Chien-Yuh Yeh, MD         
Sub-Investigator: Wen-Sy Tsai, MD         
Sub-Investigator: Shin-Yuan Hung, MD         
Sub-Investigator: Jeng-Fu You, MD         
Sub-Investigator: Sum-Fu Chiang, MD         
Sub-Investigator: Cheng-Chou Lai, MD         
Sub-Investigator: Tsai-Sheng Yang, MD         
Sub-Investigator: Hung-Chih Hsu, PhD         
Sponsors and Collaborators
Taiwan Mundipharma Pharmaceuticals Ltd.

Publications:

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Responsible Party: Taiwan Mundipharma Pharmaceuticals Ltd.
ClinicalTrials.gov Identifier: NCT03176121     History of Changes
Other Study ID Numbers: OXY16-TW-401
First Posted: June 5, 2017    Key Record Dates
Last Update Posted: June 5, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Taiwan Mundipharma Pharmaceuticals Ltd.:
Oxycodone
Cancer Pain
Long-term use

Additional relevant MeSH terms:
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Oxycodone
Cancer Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents