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

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ClinicalTrials.gov Identifier: NCT01983111
Recruitment Status : Completed
First Posted : November 13, 2013
Results First Posted : July 11, 2016
Last Update Posted : July 11, 2016
Sponsor:
Information provided by (Responsible Party):
Mundipharma Korea Ltd

Brief Summary:
The purpose of this study is to compare the efficacy and safety of buprenorphine transdermal system to tramadol/acetaminophen.

Condition or disease Intervention/treatment Phase
Pain Drug: buprenorphine Drug: tramadol/acetaminophen Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 136 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Study Start Date : October 2013
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: buprenorphine
Patch
Drug: buprenorphine
Dosage and administration: This one patch should be attached every 7 days.
Other Name: Norspan patch

Active Comparator: tramadol/acetaminophen
Oral tablet
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.


  3. 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.

  4. 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.

  5. 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).




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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01983111


Locations
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Korea, Republic of
Sanggye Paik Hospital, Dept. of Orthopedic Surgery
Seoul, Korea, Republic of
Sponsors and Collaborators
Mundipharma Korea Ltd
Investigators
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Principal Investigator: Jinhyok Kim, Dr.PhD Sanggye Paik Hospital, Dept. of Orthopedic Surgery

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Mundipharma Korea Ltd
ClinicalTrials.gov Identifier: NCT01983111     History of Changes
Other Study ID Numbers: BUP13-KR-401
First Posted: November 13, 2013    Key Record Dates
Results First Posted: July 11, 2016
Last Update Posted: July 11, 2016
Last Verified: June 2016
Additional relevant MeSH terms:
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Tramadol
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Acetaminophen
Buprenorphine
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Narcotic Antagonists