A Study to Assess the Efficacy and Safety of Oxycodone/Naloxone in Korean Patients With Chemotherapy-Induced Peripheral Neuropathy (CIPN)

• Status: Completed
• Trial end date: 2014-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mundipharma Korea Ltd
• Treatments: Naloxone; Oxycodone

Criteria

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