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

NCT01675531 | Completed Phase 4 Results

• 1 other identifier: OXN12-KR-402
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cancer

Keywords

Targin; Chemotherapy Induced Peripheral Neuropathy (CIPN)

Outcome Measures

Primary Outcomes (1)

• NRS (Numeric Rating Scale)

  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.

  4 weeks

Secondary Outcomes (3)

• Mean Change in FACT-GOG/NTX From Visit1(Week 0) to Visit 4(Week 4 Post-treatment).

  4 weeks

• Physician's Overall Satisfaction

  4 weeks

• Patient's Overall Satisfaction

  4weeks

Study Arms (1)

Targin

EXPERIMENTAL

Targin

Drug: Targin

Interventions

Targin DRUG

Single arm for Targin

Also known as: Oxycodone and Naloxone

Targin

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mundipharma Korea Ltd: lead

Study Sites (1)

Seoul ST.Mary Hospital

Seoul, Banpogu, South Korea

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Oxycodone; Naloxone

Intervention Hierarchy (Ancestors)

Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Jin-Hyong Kang
• Organization: Seoul ST.Mary's Hospital

jinkang@catholic.ac.kr

82-2-2258-6043

Study Officials

• Kang, Ph.D

  Seoul ST.Mary Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2012
• First Posted: August 30, 2012
• Study Start: December 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: June 1, 2014
• Last Updated: December 16, 2016
• Results First Posted: December 16, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)