An Interventional Study to Assess the Efficacy and Safety of Buprenorphine in Korean Patients With Spinal Disorders (NOBLE)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Dream CIS
Information provided by (Responsible Party):
Mundipharma Pte Ltd.
ClinicalTrials.gov Identifier:
NCT01818700
First received: October 18, 2012
Last updated: August 5, 2013
Last verified: August 2013
  Purpose

The purpose of this study is to assess the pain reduction rate after 8 weeks treatment of NORSPAN® from baseline.

And secondary purpose are: pain reduction rate after 4 weeks treatment from baseline(week 0) the EQ-5D, the pain and sleep questionnaire, physician's overall satisfaction subject's overall satisfaction, and safety


Condition Intervention Phase
Spinal Disorder
Drug: Buprenorphine
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 NORSPAN® (Buprenorphine) in Korean Patients With Spinal Disorders (NOBLE)

Resource links provided by NLM:


Further study details as provided by Mundipharma Pte Ltd.:

Primary Outcome Measures:
  • Pain intensity (0 -10, VAS) score-NRS(Numeric Rating Scale) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    The primary efficacy outcome is the actual reduction rate of pain intensity (0 -10, VAS) score within 8 weeks.


Secondary Outcome Measures:
  • EQ-5D-EuroQOL-5 Dimension [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

    5 Dimension

    : Subject should choose the most best description of the three statement per each question.

    And last question is 'Your own health state today'.



Other Outcome Measures:
  • Overall satisfaction of physician and subject [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Physician and subject should choose the most best description of the satisfaction seven statement.


Estimated Enrollment: 242
Study Start Date: September 2012
Estimated Study Completion Date: October 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Norspan patch (Buprenorphine)
Trade name is Norspan. Buprenorphine 5μg/h, 10 μg/h, 20 μg/h patches will be used (4 patches a box). Patch will be administered every 7th day.
Drug: Buprenorphine
8weeks treatment with Norspan®(Buprenorphine)
Other Name: Buprenorphine

Detailed Description:

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, pain and sleep questionnaire, 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 NORSPAN®.

Treatment with NORSPAN® will be started from 5 μg/h (1 patch a week) for 2 weeks, and proper titration (up-titration) will be allowed at visit 2(wk 2) and at visit 3(wk 4) according to the investigator's decision.

  Eligibility

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

Inclusion Criteria:

  • 20 years old or above male or female Korean patients
  • Patients who have spinal disorders related pain
  • Patients who had been treated with weak opioids and/or NSAIDs before study participation
  • Patients who have moderate to severe pain intensity
  • Naïve patients for Buprenorphine (Naïve patient are defined as those who had not been treated with Buprenophine 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
    • using 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 spermicide. Hormonal contraceptives include any marketed contraceptive agent that includes an estrogen and/or a 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 buprenorphine or to any of the excipients
  • Patients with severely impaired respiratory function or respiratory depression status
  • Patients concurrently receiving MAOIs or who have received MAOIs within the previous two weeks
  • Patients with convulsive disorders, head injury, shock, a reduced level of consciousness of uncertain origin, intracranial lesions or increased intracranial pressure, or in patients with severe hepatic impairment
  • Patients with biliary tract disorders
  • Patients known to have, or suspected of having a history of drug abuse
  • Patients with history of opioid or drug dependence
  • Patients who are concurrently taking other CNS depressants or muscle relaxants that may cause respiratory depression, hypotension, profound sedation or potentially result in coma.
  • Patients who are taking Buprenorphine or strong opioid.
  • Any situation where Buprenorphine is contraindicated
  • 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
  • With a disability that may prevent the patient from completing all study requirements and in particular, interfere with 24hrs pain intensity score
  • Clinically significant impairment of cardiovascular, respiratory and renal function
  • 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, or within 30 days of enrollment
  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: NCT01818700

Locations
Korea, Republic of
YeungNam University Medical center
Daegu, Korea, Republic of
Chungnam National University Hospital
Daejeon, Korea, Republic of
Chonnam National University hospital
Gwangju, Korea, Republic of
Pusan National University Yangsan Hospital
Pusan, Korea, Republic of
Hanyang University Seoul Hospital
Seoul, Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of
Gangnam Severance Hospital
Seoul, Korea, Republic of
Severance Hospital, Yonsei University Health System
Seoul, Korea, Republic of
Sponsors and Collaborators
Mundipharma Pte Ltd.
Dream CIS
Investigators
Principal Investigator: Whan Eoh Samsung Medical Center
  More Information

No publications provided

Responsible Party: Mundipharma Pte Ltd.
ClinicalTrials.gov Identifier: NCT01818700     History of Changes
Other Study ID Numbers: BUP12-KR-401
Study First Received: October 18, 2012
Last Updated: August 5, 2013
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

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

ClinicalTrials.gov processed this record on September 18, 2014