PROspective Non-interventional Open laBEl Trial for TARGIN in Korean Patients With Cancer Pain

NCT01719757 | Completed Phase 4 Results

• 1 other identifier: OXN11-KR-404
• Study Type: interventional
• Target: 359
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to evaluate the efficacy of TARGIN administration as an analgesic to Korean patients treated with opioid analgesics for moderate-to-severe cancer pain under conditions of daily practice.

Conditions

Cancer

Keywords

Targin, Cancer Pain

Outcome Measures

Primary Outcomes (1)

• Change in Numeric Rating Scales (NRS) Score

  Primary objective: Change in numeric rating scales (NRS) such as score for average pain levels over the previous 24 hours, from baseline (visit 1) to study end (visit 2). NRS score was measured from 0 (No pain) to 10(worst pain imaginable).

  4 weeks

Secondary Outcomes (3)

• Change of Eastern Cooperative Oncology Group(ECOG) Performance Status

  4weeks

• Change of Constipation Assessment From Baseline to Visit 2(End Visit)

  4 weeks

• Overall Satisfaction Assessment About Efficacy and Tolerability of Oxycodone/Naloxone by the Investigator and Subject

  4 weeks

Study Arms (1)

Oxycodone/naloxone

EXPERIMENTAL

Trade name is Targin. Oxycodone (10mg)/naloxone (5mg) or Oxycodone (20mg)/naloxone (10mg) tablets. Twice daily per oral. Dose adjustment and asymmetric dose are allowed up to 80/40mg per day

Drug: Oxycodone/Naloxone

Interventions

Oxycodone/Naloxone DRUG

Twice daily

Also known as: Targin

Oxycodone/naloxone

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 cancer patients 20 years of age or older
• Cancer related pain that requires treatment with continuous around-the-clock strong opioid analgesic
• Moderate to severe pain intensity (NRS pain score \>=4)
• Opioid naïve patients or patients not treated with strong opioids (Only except occasional PRN) within 13 months or patients who has been on weak opioids
• Ability to communicate effectively with the study personnel regarding pain intensity, constipation assessment, final assessment of overall efficacy and tolerability
• Subject who provide signed and dated written voluntary informed consent

You may not qualify if:

• Pregnant or nursing (lactating) women
• Have previously received treatment with Targin
• Patient with evidence of significant structural/functional abnormalities of GI tract which is not appropriate for oral medicine administration
• Any history of hypersensitivity to Oxycodone and Naloxone or any excipients
• Patients with significant respiratory depression
• Patients with acute or severe bronchial asthma or hypercarbia
• Any patient who has or is suspected of having paralytic ileus
• Severe Chronic obstructive pulmonary disease, pulmonary heart disease
• Targin product contains lactose. Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not take
• Patients with moderate and severe hepatic impairment
• 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)
• Any situation where opioids are contraindicated
• With a life expectancy \< 1 month
• Any situation where opioids are contraindicated
• Mainly pain originated other than cancer or cancer related conditions (eg. Musculoskeletal pain, inflammatory pain, diabetic polyneuropathy)

Sponsors & Collaborators

• Mundipharma Korea Ltd: lead

Study Sites (1)

13 sites including Yeungnam University Medical Center

Daegu, 705-717, South Korea

Location

MeSH Terms

Conditions

Neoplasms; Cancer Pain

Interventions

Oxycodone; Naloxone

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

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: CR head
• Organization: Suyoun Yang

suyoun.yang@mundipharma.co.kr

82-2-527-9219

Study Officials

• Kyeonghee Lee, PhD

  Yeongnam Univ. 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: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2012
• First Posted: November 1, 2012
• Study Start: July 1, 2012
• Primary Completion: October 1, 2013
• Study Completion: April 1, 2014
• Last Updated: August 19, 2016
• Results First Posted: August 19, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)