A Study Comparing Norspan Patch and Oral Tramadol

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mundipharma Pte Ltd.
ClinicalTrials.gov Identifier:
NCT01019265
First received: November 24, 2009
Last updated: November 17, 2011
Last verified: November 2009
  Purpose

This trial was designed for comparison and evaluation of the efficacy and safety of buprenorphine transdermal patch (Norspan® patch 5 mg, 10 mg and 20mg) against oral tramadol (Tridol® SR tablet 100mg) in patients with moderate to severe pain due to osteoarthritis.


Condition Intervention Phase
Osteoarthritis
Drug: Buprenorphine 5mg, 10mg, 20mg vs Tramadol 100mg
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: A Randomised Open Label Parallel Group Study Comparing Norspan Patch and Oral Tramadol

Resource links provided by NLM:


Further study details as provided by Mundipharma Pte Ltd.:

Primary Outcome Measures:
  • Pain intensity - BS-11 pain scale [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • WOMAC score [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Degree of sleep disturbance due to pain and improvement in quality of sleep [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Incidence of early discontinuation due to lack of efficacy [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 170
Study Start Date: March 2008
Study Completion Date: May 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Norspan patch (Buprenorphine TDS) Drug: Buprenorphine 5mg, 10mg, 20mg vs Tramadol 100mg
Comparing pain intensity between intervention drugs (Norspan® and Tridol®)
Other Names:
  • Norspan patch
  • BTDS
  • Buprenorphine transdermal system
Active Comparator: TramadolSR tab (Tridol SR tab) Drug: Buprenorphine 5mg, 10mg, 20mg vs Tramadol 100mg
Comparing pain intensity between intervention drugs (Norspan® and Tridol®)
Other Names:
  • Norspan patch
  • BTDS
  • Buprenorphine transdermal system

Detailed Description:

The primary objective of this non-inferiority study with active, parallel control group is to compare and assess efficacy and safety of buprenorphine transdermal patch (Norspan® Patch 5 mg, 10 mg and 20 mg) and tramadol (Tridol® SR Tablet 100mg) in patients with moderate to severe pain due to osteoarthritis. During the period of treatment for 8weeks, titration and maintenance is kept up after 1:1 ratio randomization.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males and females aged more than 18 years.
  • Clinical diagnosis of osteoarthritis (OA) of the hip and/or knee including fulfilling the American College of Rheumatology Criteria (ACR criteria L13) and documentation of osteoarthritis in the relevant joint.
  • Patients with moderate to severe osteoarthritis pain in the relevant joint, confirmed by BS-11 (Box Scale-11) more than 4 for their pain on average during the last week, in their primary OA joint, at both the screening and base line visits despite treatment with non-opioid analgesics.

Exclusion Criteria:

  • Patients being treated with high potency opioid analgesics (e.g., morphine, fentanyl, oxycodone, methadone, hydromorphone, ketobemidone, buprenorphine (including Norspan®)) for their osteoarthritis pain.
  • Patients who have been taking any opioid analgesics within the last 4 weeks prior to the screening visit.
  • Patients who have been using any NSAID transdermal preparation less than 2 weeks prior to the screening visit.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01019265

Locations
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Hanyang University Medical Center
Seoul, Korea, Republic of
National Medical Center
Seoul, Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Mundipharma Pte Ltd.
Investigators
Principal Investigator: Myun Chul Lee Seoul National University Hospital
  More Information

No publications provided

Responsible Party: Mundipharma Pte Ltd.
ClinicalTrials.gov Identifier: NCT01019265     History of Changes
Other Study ID Numbers: BUP07-KR-001
Study First Received: November 24, 2009
Last Updated: November 17, 2011
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Mundipharma Pte Ltd.:
Norspan patch
BTDS
Buprenorphine transdermal patch
efficacy
buprenorphine

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Buprenorphine
Tramadol
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Narcotic Antagonists

ClinicalTrials.gov processed this record on September 16, 2014