An Interventional Study to Assess the Efficacy & Safety of NCT01811238

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number	NCT01811238
Other study ID #	OXN12-KR-401
Secondary ID
Status	Recruiting
Phase	Phase 4
First received	October 22, 2012
Last updated	March 12, 2013
Start date	September 2012
Est. completion date	June 2013

Study information
Verified date	March 2013
Source	Mundipharma Pte Ltd.
Contact	Sung Soo Chung
Phone	010-9933-0385
Email	ssc0385[@]skku.edu
Is FDA regulated	No
Health authority	Korea: Food and Drug AdministrationKorea: Institutional Review Board
Study type	Interventional

Clinical Trial Summary

Study Objectives:

1. Primary objective

- To assess the pain reduction after 8 weeks treatment from baseline (week 0)

2. Secondary objectives

- To assess the pain reduction after 4 weeks treatment from baseline (week 0)

- To assess the EQ-5D

- To assess physician's overall satisfaction

- To assess subject's overall satisfaction

- To assess safety

Description:

Study Design (Methodology):

This will be a multicenter, phase IV, interventional study to assess the efficacy and safety of TARGIN(R)(Oxycodone/Naloxone) in Korean patients who are dissatisfied with their current analgesic medication (WHO step II analgesics).

Upon providing written informed consent, subject will be screened in the study and assessment will be performed at that time such as safety laboratory assessments, physical examination, vital sign, medical history taking, 24 hours pain intensity score, EQ-5D, physician's overall satisfaction and subject's overall satisfaction. If patient is eligible in inclusion/exclusion criteria at the time of visit 1, the patient will receive treatment with TARGIN(R). Re-screening, study drug dose interruption is not allowed. The duration of study drug dose interruption is defined as for 1 week.

Treatment with TARGIN(R) will be started at 5/2.5mg b.i.d.,and proper titration (up titration) will be allowed at each visit or at unscheduled visit according to the investigator's decision. On-site visit or phone call will be allowed for visit 2(wk 1).The up titration will be considered by investigator's judgement as followings; (1) if the rescue medication was used more than 2 times per day, on average or (2) based on the daily average numerical rating scale

, if the numerical rating scale was changed to worsen since the previous visit, (3) Investigator's judgement by considering any titration needed situation (e.g. dose, frequency of rescue medication). Pain assessment by investigator at each visit will be used for analysis and criteria for uptitration. Daily pain diary will be used for only criteria for uptitration.

Safety laboratories will be obtained at baseline (visit 1) and study end (visit 4) in a local laboratory. The laboratory values within 4 weeks prior to baseline (visit 1) will be allowed to use at study visit 1.

The rescue medication is the IRcodon(R).

Patients will be withdrawn from the study if the following circumstance require study drug discontinuation:

- Failure of pain control (Failure of pain control will be decided by investigators judgement, e.g. there is poor pain control or lack of efficacy despite 2~3 times of titration.)

- Adjustment of the other analgesics due to Adverse event except TARGIN(R) or IRcodon(R)

- Adjustment of the other major pain management modality (e.g. surgery, non-surgical interventional therapy, etc.)

- Withdrawal of informed consent

- Pregnancy

- Any other significant risk to the patient's safety in the clinical judgement of the investigator

Recruitment information / eligibility
Status	Recruiting
Enrollment	237
Est. completion date	June 2013
Est. primary completion date	April 2013
Accepts healthy volunteers	No
Gender	Both
Age group	20 Years to 80 Years
Eligibility	Inclusion Criteria: - Male or female = 20 and <80 years of age - Patients who have spinal disorders related pain for over 90days - Patients who have moderate to severe pain intensity which is not controlled with weak opioids or NSAIDs: NRS = 4 - Naïve patients for Oxycodone/Naloxone - Naïve patients for strong opioid - Patients who signed a written informed consent form Exclusion Criteria: - Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant. - 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/Naloxone or to any of the excipients - Patients with severe respiratory depression with hypoxia and/or hypercapnoea - Patients with severe chronic obstructive pulmonary disease - Patients with cor pulmonale - Patients with severe bronchial asthma - Patients who have been diagnosed or is suspected of having paralytic or obstructive ileus.Patients with moderate to severe hepatic impairment - Targin(R) 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 neurodestructive procedure or regional infusion - Patients with increased intracranial pressure - In the investigator's opinion, subjects who are receiving hypnotics or central nervous system (CNS) depressants that may pose a risk of additional CNS depression with opioid study medication - Patients with myxodema, not adequately treated hypothyroidism or Addisons 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 - Mainly pain originated other than spinal disorders disease - Non-malignant patients or cancer patients who are receiving any oncology treatment that could affect the measure of pain control - Patients with uncontrolled constipation regardless of laxative use and/or laxative type - 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 - Patient who needs acute dose titration or whose pain intensity fluctuate significantly in a short period according to investigator's judgment - Having used other investigational drugs at the time of enrollment No additional exclusions may be applied by the investigator, in order to ensure that the study population will be representative of all eligible patients.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

Intervention

Drug:
• Oxycodone/Naloxone
8 weeks treatment with Oxycodone/Naloxone

Locations
Country	Name	City	State
Korea, Republic of	Dong-A University Medical Center	Busan
Korea, Republic of	Chungbuk National University	Cheongju-si	Chungbukdo
Korea, Republic of	Chungnam National University Hospital	Daejeon
Korea, Republic of	Hanyang University Guri Hospital	Guri-si	Gyeonggi-do
Korea, Republic of	Inha University Hospital	Incheon
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Inje University Sanggye Paik Hospital	Seoul
Korea, Republic of	Severance Hospital, Yonsei University Health System	Seoul
Korea, Republic of	SMG - SNU Boramae Medical Center	Seoul

Sponsors *(2)*
Lead Sponsor	Collaborator
Mundipharma Pte Ltd.	Dream CIS, Inc.

Country where clinical trial is conducted

Korea, Republic of,

Outcome
Type	Measure	Description	Time frame	Safety issue
Primary	24hr pain intensity score (Numeric rating score: 0 -10)	The primary efficacy outcome is the actual reduction of pain intensity (Numeric rating score: 0 -10) score (average pain over 24 hours obtained at each visit) after 8 weeks treatment from baseline.	8 week	No
Secondary	EuroQol-5 Dimension(EQ-5D)	There are 3 statements in each question below to place a tick in one statement. A subject will indicate which statements best describe his/her own health state today. Mobility Self-care Usual Activities (e.g.work, study, housework, family or leisure activities) Pain/Discomfort Anxiety/Depression And a subject will indicate on a scale (score: 0-100) how good or bad his/her own health is today.	8 week	No
Secondary	Overall satisfaction of Physicians and subjects	Physicians will choose the best opinion of his/her overall satisfaction among Clinical Global Impression of Change Scale(CGIC) 7 point scale. Subjects will choose the best opinion of his/her overall satisfaction among Patient Global Impression of Change Scale(PGIC) 7 point scale.	8 week	No
Secondary	24hr pain intensity score (Numeric rating score: 0 -10)	The secondary efficacy outcome is the actual reduction of pain intensity (Numeric rating score: 0 -10) score (average pain over 24 hours obtained at each visit) after 4 weeks treatment from baseline.	4 week	No

An Interventional Study to Assess the Efficacy and Safety of Oxycodone/Naloxone in Korean Patients With Spinal Disorders

Clinical Trial Details — Status: Recruiting

Administrative data

Study information

Clinical Trial Summary

Description:

Recruitment information / eligibility

Study Design

Related Conditions & MeSH terms

Intervention

Locations

Sponsors (2)

Country where clinical trial is conducted

Outcome