Clinical trial · Interventional
A Study to Assess the Efficacy and Safety of Oxycodone/Naloxone in Korean Patients With Chemotherapy-Induced Peripheral Neuropathy (CIPN)
A Multicenter, Phase IV, Interventional Study to Assess the Efficacy and Safety of Oxycodone/Naloxone in Korean Patients With Chemotherapy-Induced Peripheral Neuropathy Who Need Opioid Combination Treatment With Existing Pregabalin Treatment
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A multicenter, phase IV, interventional study to assess the efficacy and safety of Targin (Oxycodone/Naloxone) Korean patients with CIPN (Chemotherapy-Induced Peripheral Neuropathy) who need opioid combination treatment with existing pregabalin of last dose prior to study enrollment without changing. The investigators will assess study objectives as below. Primary objective * To assess the pain reduction rate after 4 weeks treatment from baseline (week 0) Secondary objectives * To assess the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACIT-GOG/NTX) * To assess physician's overall satisfaction * To assess subject's overall satisfaction * To assess safety The investigators have a hypothesis that Targin will show favorable efficacy \& safety profile for CIPN patients.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Targin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Targin
- description
- Targin
- interventionNames
- Drug: Targin
Primary outcomes (1)
- measure
- NRS (Numeric Rating Scale)
- timeFrame
- 4 weeks
- description
- Change of pain intensity score via NRS after vist 4 weeks treatment from baseline (week 0). NRS-Pain scale assessed the severity of a subject's pain of mean pain over the past 24 hours prior to the visit on a scale of 0 (No pain) and 10 (Worst possible pain). Change = mean score at Week4/ET minus mean score at Baseline.
Secondary outcomes (3)
- measure
- Mean Change in FACT-GOG/NTX From Visit1(Week 0) to Visit 4(Week 4 Post-treatment).
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * Male or female ≥ 20 and \<80 years of age * Patients who has diagnosed as Chemotherapy-Induced Peripheral Neuropathy by investigator's judgment * Patient who are receiving pregabalin for the treatment of Chemotherapy- Induced Peripheral Neuropathy * Patients who have moderate to severe pain intensity which is not controlled with 300mg of pregabalin per day for at least 1 week: NRS ≥ 4 * Patients who need opioid combination treatment with existing pregabalin treatment * Naïve patients for strong opioid (Naïve patient defined as who did not treated for 90 days) * Patients who signed a written informed consent form Exclusion Criteria: * Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant. UNLESS they are: * women whose partners have been sterilized by vasectomy or other means * two birth control methods. The two methods can be a double barrier method or a barrier method plus a hormonal method. Adequate barrier methods of contraception include: diaphragm, condom (by the partner), intrauterine device (copper or hormonal), sponge or spermicidal. Hormonal contraceptives include any marketed contraceptive agent that includes an estrogen and/or (Progest - progesterone) progestational agent. * Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive urine pregnancy test * Patients with known hypersensitivity to Oxycodone or Naloxone or to any of the excipients * Patients with severe respiratory depression with hypoxia and/or hypercapnia * Patients with severe chronic obstructive pulmonary disease * Patients with cor pulmonale * Patients with severe bronchial asthma * Patients with non-opioid induced paralytic ileus * Patients with moderate to severe hepatic impairment * Targin product contains lactose. Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not take * Abnormal aspartate aminotransferase (AST; SGOT), alanine aminotransferase (ALT; SGPT), or alkaline phosphatase levels (\>2.5 times the upper limit of normal, it is allowed \>5 times the upper limit of normal in case of transition in liver) or an abnormal total bilirubin and/or creatinine level(s) (greater than 1.5 times the upper limit of normal), gamma glutamyl transpeptidase (GGT or GGTP) ≥ 3 times the upper limit of normal * Patients with uncontrolled seizures * Requiring interventional treatment for pain such as neural blockade procedure or regional infusion * Patients with increased intracranial pressure * In the investigator's opinion, subjects who are receiving hypnotics or other central nervous system (CNS) depressants that may pose a risk of additional CNS depression with opioid study medication * Patients with myxoedema, not adequately treated hypothyroidism or Addison's disease * Patients receiving opioid substitution therapy for opioid addiction (e.g. methadone or buprenorphine) * Clinically significant impairment of cardiovascular, respiratory and renal function * Major surgery within 1 month prior to screening or planned surgery * Chemotherapy or radiotherapy within 2 weeks prior to the screening visit, or planned chemotherapy or radiotherapy during the study period. * Mainly pain originated other than Chemotherapy-Induced Peripheral Neuropathy * Patients with diabetic neuropathy * With a disability that may prevent the patient from completing all study requirements and in particular, interfere with 24hrs pain intensity score * Patients known to have, or suspected of having a history of drug abuse * Patients with history of opioid or drug dependence * Any situation where opioids are contraindicated * Having used other investigational drugs at the time of enrollment, or within 30 days of enrollment
References
Publications (0)
Data not yet available