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

NCT01983111 | Completed Phase 4 Results

• 1 other identifier: BUP13-KR-401
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

• Change in the Pain Intensity Score (0-10 NRS) From Visit 1 (Baseline) to 6weeks After Treatment.

  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.

  baseline and 6 weeks

Secondary Outcomes (5)

• Change in the Pain Intensity Score (0-10 NRS) From Visit 1 (Baseline) to Week 2 of the Investigational Product Administration

  2 weeks

• Change in the Quality of Life (EQ-5D) Score From Visit 1 (Baseline) to Week 6 Post-dose

  Baseline and at 6 weeks

• Change From Baseline in Health-related Quality of Life Assessed by EuroQol Visual Analog Scale (EQ-5D VAS)

  Baseline and at 6weeks

• Clinical Global Impression of Change(CGIC)

  6 weeks

• Patient Global Impressions of Change(PGIC)

  6 weeks

Study Arms (2)

buprenorphine

EXPERIMENTAL

Patch

Drug: buprenorphine

tramadol/acetaminophen

ACTIVE COMPARATOR

Oral tablet

Drug: tramadol/acetaminophen

Interventions

buprenorphine DRUG

Dosage and administration: This one patch should be attached every 7 days.

Also known as: Norspan patch

buprenorphine

tramadol/acetaminophen DRUG

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.

Also known as: Ultracet ER semi

tramadol/acetaminophen

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mundipharma Korea Ltd: lead

Study Sites (1)

Sanggye Paik Hospital, Dept. of Orthopedic Surgery

Seoul, South Korea

Location

Related Publications (1)

• 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.

  PMID: 29056859 DERIVED

MeSH Terms

Conditions

Pain

Interventions

Buprenorphine; Ultracet

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

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: PhD. Miyoung Song
• Organization: Mundipharma Korea Ltd.

miyoung.song@mundipharma.co.kr

Study Officials

• Jinhyok Kim, Dr.PhD

  Sanggye Paik Hospital, Dept. of Orthopedic Surgery

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2013
• First Posted: November 13, 2013
• Study Start: October 1, 2013
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: July 11, 2016
• Results First Posted: July 11, 2016

Record last verified: 2016-06

Locations

KR (1)