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

NCT ID: NCT01983111

Last Updated: 2016-07-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 136 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2014-11-30

Brief Summary

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

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

buprenorphine

Patch

Group Type: EXPERIMENTAL

buprenorphine

Intervention Type: DRUG

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

tramadol/acetaminophen

Oral tablet

Group Type: ACTIVE_COMPARATOR

tramadol/acetaminophen

Intervention Type: 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.

Interventions

buprenorphine

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

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Norspan patch; Ultracet ER semi

Eligibility 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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mundipharma Korea Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jinhyok Kim, Dr.PhD

Role: PRINCIPAL_INVESTIGATOR

Sanggye Paik Hospital, Dept. of Orthopedic Surgery

Locations

Sanggye Paik Hospital, Dept. of Orthopedic Surgery

Seoul, , South Korea

Countries

South Korea

References

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.

Reference Type: DERIVED

PMID: 29056859 (View on PubMed)

Other Identifiers

BUP13-KR-401

Identifier Type: -

Identifier Source: org_study_id