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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by Mundipharma Pte Ltd.
Sponsor:
Collaborator:
DreamCIS
Information provided by (Responsible Party):
Mundipharma Pte Ltd.
ClinicalTrials.gov Identifier:
NCT01811238
First received: October 22, 2012
Last updated: March 12, 2013
Last verified: March 2013
  Purpose

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

Condition Intervention Phase
Spinal Disorders Related Pain
Drug: Oxycodone/Naloxone
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: A Multicenter, Phase IV, Interventional Study to Assess the Efficacy and Safety of TARGIN(R) (Oxycodone/Naloxone) in Korean Patients With Spinal Disorders

Resource links provided by NLM:


Further study details as provided by Mundipharma Pte Ltd.:

Primary Outcome Measures:
  • 24hr pain intensity score (Numeric rating score: 0 -10) [ Time Frame: 8 week ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • EuroQol-5 Dimension(EQ-5D) [ Time Frame: 8 week ] [ Designated as safety issue: No ]

    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.

    1. Mobility
    2. Self-care
    3. Usual Activities (e.g.work, study, housework, family or leisure activities)
    4. Pain/Discomfort
    5. Anxiety/Depression

    And a subject will indicate on a scale (score: 0-100) how good or bad his/her own health is today.


  • Overall satisfaction of Physicians and subjects [ Time Frame: 8 week ] [ Designated as safety issue: No ]

    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.


  • 24hr pain intensity score (Numeric rating score: 0 -10) [ Time Frame: 4 week ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 237
Study Start Date: September 2012
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Oxycodone/Naloxone
Single-arm study
Drug: Oxycodone/Naloxone
8 weeks treatment with Oxycodone/Naloxone
Other Name: Oxycodone/Naloxone

Detailed 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
  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01811238

Contacts
Contact: Sung Soo Chung 010-9933-0385 ssc0385@skku.edu
Contact: Junhee Kang 010-9933-5256 cyangale@naver.com

Locations
Korea, Republic of
Chungbuk National University Not yet recruiting
Cheongju-si, Chungbukdo, Korea, Republic of, 123-456
Hanyang University Guri Hospital Not yet recruiting
Guri-si, Gyeonggi-do, Korea, Republic of, 471-701
Dong-A University Medical Center Not yet recruiting
Busan, Korea, Republic of, 602-715
Chungnam National University Hospital Not yet recruiting
Daejeon, Korea, Republic of, 301-721
Inha University Hospital Recruiting
Incheon, Korea, Republic of, 400-711
Asan Medical Center Not yet recruiting
Seoul, Korea, Republic of, 138-736
Severance Hospital, Yonsei University Health System Not yet recruiting
Seoul, Korea, Republic of, 120-752
SMG - SNU Boramae Medical Center Recruiting
Seoul, Korea, Republic of, 156-707
Inje University Sanggye Paik Hospital Recruiting
Seoul, Korea, Republic of, 139-707
Sponsors and Collaborators
Mundipharma Pte Ltd.
DreamCIS
Investigators
Principal Investigator: Sung Soo Shung Samsung Medical Center
  More Information

No publications provided

Responsible Party: Mundipharma Pte Ltd.
ClinicalTrials.gov Identifier: NCT01811238     History of Changes
Other Study ID Numbers: OXN12-KR-401
Study First Received: October 22, 2012
Last Updated: March 12, 2013
Health Authority: Korea: Food and Drug Administration
Korea: Institutional Review Board

Keywords provided by Mundipharma Pte Ltd.:
spinal disorders

Additional relevant MeSH terms:
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Naloxone
Oxycodone
Narcotic Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Narcotics
Central Nervous System Depressants
Analgesics
Analgesics, Opioid

ClinicalTrials.gov processed this record on July 26, 2014