Clinical Trials Logo
NCT number NCT03176121
Study type Interventional
Source Taiwan Mundipharma Pharmaceuticals Ltd.
Contact Brook Chung, MSc
Phone 886-2-87297521
Email brook.chung@mundipharma.com.tw
Status Recruiting
Phase Phase 4
Start date October 31, 2016
Completion date December 31, 2018

Clinical Trial 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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


See also
Status Clinical Trial Phase
 Completed NCT01441141 - Genetics and Pain Severity in Sickle Cell Disease N/A
 Completed NCT02913027 - Can We Improve the Comfort of Pelvic Exams? N/A
 Terminated NCT02181387 - Acetaminophen Use in Labor - Does Use of Acetaminophen Reduce Neuraxial Analgesic Drug Requirement During Labor? N/A
 Completed NCT01077414 - Phenomenological Study of Psycho-Socio-Spiritual Healing in the Context of Chronic or Life-Threatening Illness N/A
 Completed NCT01198197 - PET Brain and Whole Body Distribution Studies for Nociceptin/Orphanin FQ Peptide (NOP) Receptor Using [11C]NOP-1A Early Phase 1
 Recruiting NCT02839889 - Tolerability, Safety, and Feasibility of Naloxegol in Patients With Cancer and OIC (Opioid Induced Constipation) Phase 4
 Recruiting NCT02943772 - Does Local Cooling of Testis in Patients With Epididymitis Relieve Pain and Reduce Quantity of Analgetics Intake? N/A
 Recruiting NCT02917603 - Shared Decision Making to Improve Palliative Care in the Nursing Home N/A
 Recruiting NCT02911168 - Comparison of US-Guided Paravertebral and Proximal Intercostal Nerve Blocks N/A
 Recruiting NCT02829736 - ThOracoscopic Wedge Resection Treated With Chest Tube Removal Intraoperatively N/A
 Recruiting NCT02885051 - Evaluation of Pain in Preterm Newborn N/A
 Recruiting NCT02913833 - The Impact of Pain Assessment on the Hospital Length of Stay of Patients in a Rehabilitation Unit N/A
 Not yet recruiting NCT02819544 - Evaluation of the Interest of the Instillation of Saline Intraperitoneally (INSI ) Versus Instillation of Naropin the Surgical Site Versus Lung Recruitment Maneuvers ( PVM ) in the Management of Pain After Laparoscopic Cholecystectomy in Ambulatory Care Phase 3
 Not yet recruiting NCT02840942 - Robots to Reduce Pain During IV Placement N/A
 Completed NCT02876705 - Spatiotemporal Patterns of Pain During Exercise Phase 0
 Not yet recruiting NCT02840838 - Botulinum Toxin for Post Abdominoplasty Pain Control Phase 4
 Not yet recruiting NCT02834481 - Assessment of Pain Monitoring With ANI/NIPE Monitor Program in Pediatric Cardiac Surgery Postoperative. Phase 4
 Not yet recruiting NCT02854553 - TAP Block Alone Versus TAPblock With Rectus Sheath Block in Liposuction Surgery N/A
 Not yet recruiting NCT02851940 - Pain and Bleeding Following Hypertonic Saline Sclerotherapy Compared to Brand Ligation for Symptomatic Hemorrhoids N/A
 Not yet recruiting NCT02847013 - The Use of Liposomal Bupivacaine in TAP Blocks for Women Undergoing Cesarean Section Phase 2/Phase 3