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A Study to Compare the Titration Efficacy and Safety of Control-released Oxycodone and Immediate-released Oxycodone in Patients With Moderate to Severe Cancer Pain

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ClinicalTrials.gov Identifier: NCT03176199
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 efficacy and safety of a titration method by selects 10 mg control-released (CR) oxycodone tablet as background drug in combined with immediate-released (IR) oxycodone, compared to conventional titration method with immediate-released (IR) oxycodone in patients with moderate to severe cancer pain in Taiwan.

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

Detailed Description:

This is an interventional, open label, randomized controlled study carrying in multi-centers. Eighty opioid-naive patients with moderate to severe cancer pain (≥ 4) in outpatient department (OPD), who agreed and signed informed consent will be randomly assigned in a 1:1 ratio to receive CR + IR oxycodone or conventional IR oxycodone groups. The study is to compare the titration efficacy and safety of CR with IR oxycodone (experimental group) comparing IR oxycodone (control group) in cancer patients suffered with moderate to severe pain. The study last 14 days. Patients begin the study by the first day visit of the clinic and received the study medication (Baseline). Following visits on cycle 1 (day 3 or 4 depends on the available clinics), cycle 2 (day 7±1), cycle 3 (day 10±1), and cycle 4 (day 14±1). In the experimental group, 10 mg CR oxycodone tablet will be selected as background dose of titration, and patients will be administered once every 12 hrs. Meanwhile, the titration with IR oxycodone will be added according to the pain intensity, e.g. if patient receiving 6 tablets of 10 mg CR oxycodone (giving in Q12H frequency for 3 days), 12 capsules of 5mg IR oxycodone will be dispensed for managing acute pain (rescue use) for the first cycle. In the control group, the conventional titration with IR oxycodone will be conducted according to pain intensity, using 5 mg as initial dose, e.g. 12 capsules of 5mg IR oxycodone (giving in Q6H frequency for 3 days), 12 capsules of 5mg IR oxycodone will be dispensed for rescue use upon to the first cycle. Patient will record their pain score (4 times in Q6H frequency and before taking the drug), 24hr total dose (total tablets/capsule number), number of breakthrough pain and PRN time and dosage used onto the patient diary. The background dose of each patient will be titrated after cycle 1 by investigators. Titration cycles will be recorded and evaluated pain assessments on cycle 2 (day 7±1), cycle 3 (Day 10±1), cycle 4 (day 14±1). During study, the study nurse will follow patient's daily records, drug use condition every second day by telephone or other contact methods to keep close monitor of patient's condition. The telephone contact for cycle 1 and cycle 3 is acceptable for this study. If the telephone contact is conducted for patient, the 1-week quantities of oxycodone should be dispensed to patient.

The safety for individual patient will be followed during study up to end of treatment (EOT) or early termination (ET). All adverse events (AE(s)) and serious adverse events (SAE(s)) occurred during the study period will be followed until resolution or the event is considered stable.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: An Interventional, Open Label, and Randomized Controlled Study to Compare the Titration Efficacy and Safety of Control-released Oxycodone and Immediate-released Oxycodone in Opioid-naive Patients With Moderate to Severe Cancer Pain
Actual Study Start Date : September 1, 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: Control-released oxycodone
Control-released oxycodone Q12H, initial daily dose is 20 mg + immediate-released oxycodone for PRN
Drug: Oxycodone
Every 12 hours for control-released oxycodone (OxyContin®)

Active Comparator: Immediate-released oxycodone
Immediate-released oxycodone Q6H, initial daily dose is 20mg + immediate-released oxycodone for PRN
Drug: Oxycodone
Every 6 hours for immediate-released oxycodone (OxyNorm®)




Primary Outcome Measures :
  1. To evaluate the variable change of NRS pain score and the number of breakthrough pain to obtain pain control after treatment [ Time Frame: Up to 14 days ]
    The change from baseline of NRS pain score and the daily number of breakthrough pain


Secondary Outcome Measures :
  1. To evaluate the percentage of patients in each titration cycle [ Time Frame: Up to 14 days ]
    The percentage of patients in each titration cycle

  2. To evaluate the number of patients who switched/discontinued therapy due to serious adverse events or lack of pain control [ Time Frame: Up to 14 days ]
    The number of patients who switched/discontinued therapy due to serious adverse events or lack of pain control

  3. The total opioid taken within 24hrs daily from baseline to day 14 [ Time Frame: Up to 14 days ]
    The total opioid taken within 24 hrs daily from baseline to day 14

  4. To evaluate the mean daily NRS score of subjects from baseline to day 14 [ Time Frame: Up to 14 days ]
    Mean daily NRS score of patients from baseline to day 14

  5. To evaluate the total daily rescue dose taken (immediate-released oxycodone capsule) for treatment of breakthrough pain among patients from baseline to day 14 [ Time Frame: Up to 14 days ]
    The total daily rescue dose taken (immediate-released oxycodone capsule) for treatment of breakthrough pain among patients from baseline to day 14

  6. To evaluate the tolerability and safety of Oxycodone CR and IR in cancer pain patient [ Time Frame: Up to 28 days ]
    The occurrence rate of adverse events and physical examination status

  7. To evaluate the change from baseline in questionnaire [ Time Frame: Up to 14 days ]
    The change from baseline in questionnaire



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. Patients with background cancer pain more than or equal to NRS 4 during previous 24 hours, or receive more than or equal to 3 times/day for breakthrough pain medication management
  3. ECOG ≤ 2
  4. Opioid-naive patients who are not administrated any strong opioid for at least one month prior to the index treatments, who currently with poor pain control and intended to be treated for pain relief with strong opioids. The FDA identifies opioid-naive as who not receiving the following treatment for a week or longer of strong opioids:

1) ≥ 60 mg of morphine daily 2) ≥25 mcg transdermalfentanyl/hour 3) ≥ 8 mg of oral hydromorphone daily or 4) an equianalgesic dose of another opioid

5) Patients who will not be treated with radiotherapy within 7 days prior to randomization and during study

6) Patients who need chemotherapy, long term administration of hormone, targeted therapy, or bisphosphonates therapy should undergo a stable anti-tumor therapy prior to randomization.

7) Patients or his/her caregivers who are able to fill out the diary and questionnaire forms

Exclusion Criteria:

  1. Patients diagnosed with non-cancer pain or unexplained pain
  2. Patients suffered with post-op pain
  3. Patients who cannot be applicable for oral administration
  4. Patients who have severe constipation defined by CTCAE grade 3 and above
  5. Patients with any disease that may easily lead to respiratory depression
  6. Monoamine oxidase inhibitor (MAOI) was administrated one week before randomization
  7. There are 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
  8. Patients who have potential risk for surgical operation, which may lead to gastrointestinal stenosis, blind loop or gastrointestinal obstruction; or patient is unable to effectively absorb oral medication through gastrointestinal tract
  9. Patients who are drug or alcohol abuse
  10. Patients with moderate to severe psychiatric problems
  11. Patients who have hypersensitivity to oxycodone
  12. Patients who are pregnant or lactating
  13. 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): NCT03176199


Contacts
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Contact: Chih-Jen Hung, MSc 886-4-23592525 ext 4101 hung@vghtc.gov.tw

Locations
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Taiwan
Changhua Christian Hospital Recruiting
Chang-hua, Taiwan, 500
Contact: Yi-Zhe Hsieh, MD    886-4-7238595 ext 5311    67259@cch.org.tw   
Principal Investigator: Yi-Zhe Hsieh, MD         
Sub-Investigator: Shih-Kai Lin, MD         
Sub-Investigator: Shao-Lun Tsao, MD         
Sub-Investigator: Pei-Yu Tsai, MD         
Sub-Investigator: Cheng-Shyong Chang, MD         
Sub-Investigator: Hsuan-Yu Lin, MD         
Taichung Veterans General Hospital Recruiting
Taichung, Taiwan, 40705
Contact: Chih-Jen Hung, MSc    886-4-23592525 ext 4101    hung@vghtc.gov.tw   
Principal Investigator: Chih-Jen Hung, MSc         
Sub-Investigator: Chih-Cheng Wu, MSc         
Sub-Investigator: Joe-Bin Chen, MD         
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 10002
Contact: Wei-Han Chou, MD    886-2-23123456 ext 62158    brokenarrowchou@yahoo.com.tw   
Principal Investigator: Wei-Han Chou, MD         
Sub-Investigator: Chih-Peng Lin, PhD         
Sub-Investigator: Yu-Yun Shao, PhD         
Taipei Veterans General Hospital Recruiting
Taipei, Taiwan, 11217
Contact: Ta-Chung Chao, PhD    886-2-28712121 ext 2525    tcchao@vghtpe.gov.tw   
Principal Investigator: Ta-Chung Chao, PhD         
Sponsors and Collaborators
Taiwan Mundipharma Pharmaceuticals Ltd.
Investigators
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Principal Investigator: Chih-Jen Hung, MSc Taichung Veterans General Hospital

Publications:

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Responsible Party: Taiwan Mundipharma Pharmaceuticals Ltd.
ClinicalTrials.gov Identifier: NCT03176199     History of Changes
Other Study ID Numbers: OXY15-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.:
control-released oxycodone
immediate-released oxycodone
cancer pain
opioid-naive

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