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Compare the Efficacy and Safety of Norspan to Tramadol/Acetaminophen With Prolonged Postoperative Pain (PASSION)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01983111
Recruitment Status : Completed
First Posted : November 13, 2013
Results First Posted : July 11, 2016
Last Update Posted : July 11, 2016
Information provided by (Responsible Party):
Mundipharma Korea Ltd

Tracking Information
First Submitted Date  ICMJE October 14, 2013
First Posted Date  ICMJE November 13, 2013
Results First Submitted Date  ICMJE September 1, 2015
Results First Posted Date  ICMJE July 11, 2016
Last Update Posted Date July 11, 2016
Study Start Date  ICMJE October 2013
Actual Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 1, 2016)
Change in the Pain Intensity Score (0-10 NRS) From Visit 1 (Baseline) to 6weeks After Treatment. [ Time Frame: baseline and 6 weeks ]
NRS-Pain scale assessed the severity of a subject's pain of mean pain over the past 24 hours prior to the visit on a scale of 0 (No pain) and 10 (Worst possible pain). Change = mean score at Week6/ET minus mean score at Baseline.
Original Primary Outcome Measures  ICMJE
 (submitted: November 5, 2013)
efficacy [ Time Frame: 6 weeks ]
assess NRS score between baseline and 6 weeks
Change History Complete list of historical versions of study NCT01983111 on Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 1, 2016)
  • Change in the Pain Intensity Score (0-10 NRS) From Visit 1 (Baseline) to Week 2 of the Investigational Product Administration [ Time Frame: 2 weeks ]
    NRS-Pain scale assessed the severity of a subject's pain of mean pain over the past 24 hours prior to the visit on a scale of 0 (No pain) and 10 (Worst possible pain). Change = mean score at Week 2/ET minus mean score at Baseline.
  • Change in the Quality of Life (EQ-5D) Score From Visit 1 (Baseline) to Week 6 Post-dose [ Time Frame: Baseline and at 6 weeks ]
    EQ-5D to measure of health related quality of life should be answered as one of 3 levels about current condition for 5 dimensions for 'Motor capability', 'Self-care', 'Daily activities', 'Pain/discomfort', 'Depression/anxiety' and was calculated total average by giving a weighting on 3 level of answers (EQ-5D levels into 'no problems' (level 1) and 'problems' (level 2 and 3)). *EQ-5D Total = 1 - 0.081 - (the score of the each level) - 0.269 (if at least one of level 3 presents) EQ-5D total score could be 0.919 in maximum and -0.594 in minimum if case all index indicates the level 3. So, if EQ-5D total score closed by "1" means that the healthy condition and high quality of life.
  • Change From Baseline in Health-related Quality of Life Assessed by EuroQol Visual Analog Scale (EQ-5D VAS) [ Time Frame: Baseline and at 6weeks ]
    The EQ VAS records the respondent's self-rated health on a vertical, visual analogue scale where the endpoints are labelled 'Best imaginable health state' (score = 100) and 'Worst imaginable health state' (score = 0). Higher points were positive results and positive points of difference gap means improvement results.
  • Clinical Global Impression of Change(CGIC) [ Time Frame: 6 weeks ]
    The number of patients who choose the best opinion of overall satisfaction among Clinical Global Impression of Change Scale(CGIC) among 7 point scale. Missing data was imputed by LOCF. Scores measure from 1: Very much improved to 7:very much worse.
  • Patient Global Impressions of Change(PGIC) [ Time Frame: 6 weeks ]
    In the PP set, Number of participants with categorical change in overall satisfaction. PGIC: a participant-rated instrument assessing change in participant's overall satisfaction from baseline, on a scale ranging from 1 (very much improved) to 7 (very much worse).
Original Secondary Outcome Measures  ICMJE
 (submitted: November 5, 2013)
life of quality [ Time Frame: 6 weeks ]
assess the life of quality
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Compare the Efficacy and Safety of Norspan to Tramadol/Acetaminophen With Prolonged Postoperative Pain (PASSION)
Official Title  ICMJE A Multicenter, Phase IV, Interventional Study to Compare the Efficacy and Safety of NORSPAN to Tramadol/Acetaminophen in Patients With Prolonged Postoperative Pain After Spinal Surgery (PASSION)
Brief Summary The purpose of this study is to compare the efficacy and safety of buprenorphine transdermal system to tramadol/acetaminophen.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pain
Intervention  ICMJE
  • Drug: buprenorphine
    Dosage and administration: This one patch should be attached every 7 days.
    Other Name: Norspan patch
  • Drug: tramadol/acetaminophen

    Amount of drug ingredients

    : Acetaminophen 325 mg and Tramadol hydrochloride 37.5 mg in 1 tablet of this drug.

    Dosage and administration:

    Adjust dose depending on a patient's pain severity and treatment response. Starting at the initial dose of 2 tablets, usually administer 4 tablets per dose, twice daily. At a dosing interval of at least 12 hr, the daily dose should not exceed 8 tablets.

    Other Name: Ultracet ER semi
Study Arms  ICMJE
  • Experimental: buprenorphine
    Intervention: Drug: buprenorphine
  • Active Comparator: tramadol/acetaminophen
    Oral tablet
    Intervention: Drug: tramadol/acetaminophen
Publications * Lee JH, Kim JH, Kim JH, Kim HS, Min WK, Park YS, Lee KY, Lee JH. Efficacy and Safety of Transdermal Buprenorphine versus Oral Tramadol/Acetaminophen in Patients with Persistent Postoperative Pain after Spinal Surgery. Pain Res Manag. 2017;2017:2071494. doi: 10.1155/2017/2071494. Epub 2017 Sep 13.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 7, 2015)
Original Estimated Enrollment  ICMJE
 (submitted: November 5, 2013)
Actual Study Completion Date  ICMJE November 2014
Actual Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Korean men and women aged 20 years or more
  • Presence of pain associated with a spinal disease and lumbar fusion at 1-2 spinal segments (1-2 level lumbar fusion surgery)
  • Moderate to severe pain of the NRS pain score ≥ 4 at Visit 1 (14~90 days after surgery, Baseline) (Amended 21Nov2013)
  • Consent to participate in the study and voluntary signature on the informed consent form

Exclusion Criteria:

  • Women of childbearing potential, except for the following cases:
  • A partner who is vasectomized or otherwise surgically sterile.
  • Use of 2 contraception methods. Two methods include the combination of double-barrier contraception or barrier contraception and hormone contraception, and appropriate barrier methods are as follows: Diaphragm (female contraceptive device), condom, intrauterine (copper or hormone), sponge or spermicide. Hormonal contraceptives include all commercially available products containing estrogen and/or progesterone.
  • Pregnant or breastfeeding women. Pregnant woman is defined as a woman after fertilization to late pregnancy with a positive result from the urine pregnancy test.
  • History of hypersensitivity to buprenorphine, tramadol, APAP or excipients, and celecoxib
  • Medical history of asthma, acute rhinitis, nasal polyp, vascular edema urticaria or allergic reaction to aspirin or other non-steroidal anti-inflammatory drugs(NSAIDs, COX-2)
  • Hypersensitivity or intolerance to Domperidone
  • Risk of gastrointestinal irritation such as gastrointestinal bleeding, mechanical ileus or perforation
  • Genetic problem such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
  • Severely impaired respiratory function or respiratory depression
  • Current use of monoamine oxidase(MAO) inhibitors or the medication history within 2 weeks prior to study participation
  • Convulsive disorder, head injury, shock, decreased level of consciousness of uncertain origin, intracranial lesion or increased intracranial pressure or severe hepatic impairment
  • Biliary tract disorder
  • Presence or suspected drug abuse history
  • Medical history of opioid or drug dependence
  • Current use of other CNS inhibitors or muscle relaxants that may result in dyspnea, hypotension, severe sedation or coma when used with the investigational product, opioid analgesics
  • Use of strong opioids, buprenorphine or tramadol/APAP within 1 week prior to study participation (however, study participation is allowed for PRN prescription of PCA and strong opioids)
  • Any condition representing a contraindication of application of buprenorphine, tramadol/APAP or celecoxib
  • Major pain not attributable to a spinal disease
  • Anticancer therapy that may affect pain assessment
  • Clinically significant cardiovascular or renal dysfunction
  • Postoperative complications
  • Symptoms of acute pain after lumbar fusion or characteristic analgesic features showing rapidly changing needs for analgesics
  • Current use of other investigational product at enrollment or within 30 days after administration of other investigational product
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT01983111
Other Study ID Numbers  ICMJE BUP13-KR-401
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mundipharma Korea Ltd
Study Sponsor  ICMJE Mundipharma Korea Ltd
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jinhyok Kim, Dr.PhD Sanggye Paik Hospital, Dept. of Orthopedic Surgery
PRS Account Mundipharma Korea Ltd
Verification Date June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP