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

NCT01818700 | Completed Phase 4 Results DMC

• 1 other identifier: BUP12-KR-401
• Study Type: interventional
• Target: 245
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Spinal Disorder

Outcome Measures

Primary Outcomes (1)

• Change of Pain Intensity* at Week 8 of Treatment With the Study Drug From Baseline

  NRS-Pain scale assessed the severity of a subject's lower back pain on a scale of 0 (No pain) and 10 (Worst possible pain). NRS-Pain scale: Change = mean score at Week 8/ET minus mean score at Baseline.

  8 weeks

Secondary Outcomes (5)

• Change of Pain Intensity at 4 Week of Treatment With Study Srug From Baseline.

  4 weeks

• Change in Quality of Life at 8 Week of Treatment With Study Drug From Baseline

  8 weeks

• Change of EQ-VAS at 8 Weeks of Treatment With Study Drug From Baseline.

  8 week

• Clinician Global Impression of Change(CGIC)

  8weeks

• Patients Global Impression og Change(PGIC)

  8 week

Study Arms (1)

Single arm-Norspan patch (Buprenorphine)

OTHER

This trial is single arm with Norspan patch. Treatment with NORSPAN Ò 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. The up-titration will be considered by investigator's judgement as follows; (1) if the rescue medication was used more than 2 times per day, on average or (2) based on the daily average NRS(Numeric Rating Scale), if the NRS 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).

Drug: Buprenorphine

Interventions

Buprenorphine DRUG

8weeks treatment with Norspan®(Buprenorphine)

Single arm-Norspan patch (Buprenorphine)

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 Buprenorphine 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
• 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

Sponsors & Collaborators

• Mundipharma Korea Ltd: lead

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Spinal Diseases

Interventions

Buprenorphine

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

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: Dr. Whan Eoh
• Organization: Department of Neurosurgery, Samsung Medical Center, Sungkyunkwan University school of medicine, Seoul Korea

w.eoh@samsung.com

82-2-3410-3491

Study Officials

• Whan Eoh

  Samsung Medical Center

  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: October 18, 2012
• First Posted: March 26, 2013
• Study Start: September 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: October 22, 2015
• Results First Posted: September 22, 2015

Record last verified: 2015-10

Locations

KR (1)