Norspan® Patches Versus Tramadol in Subjects With Chronic, Moderate to Severe Osteoarthritis Pain in the Hip Knee and/or Lumbar Spine

NCT00426647 | Completed Phase 4

• 2 other identifiers: BUP4006NORTOP
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this equivalence study is to evaluate the efficacy of Norspan® patches versus Tramadol in subjects with chronic, moderate to severe osteoarthritis pain of the hip, knee and/or lumbar spine. The secondary objectives are to evaluate the safety and general satisfaction for the patients in the two treatment groups.

Conditions

Osteoarthritis; Pain

Keywords

Osteoarthritis; Pain; Norspan; Buprenorphine; Tramadol

Outcome Measures

Primary Outcomes (1)

• Equivalence study to evaluate the efficacy of Norspan® patches versus Tramadol in subjects with chronic, moderate to severe osteoarthritis pain of the hip, knee and/or lumber spine.

Secondary Outcomes (1)

• To evaluate the safety and general satisfaction for the patients in the two treatment groups.

Study Arms (2)

Buprenorphine

EXPERIMENTAL

Norspan transdermal patch

Drug: Buprenorphine

Tramadol

ACTIVE COMPARATOR

Tramadol SR tablets

Drug: Tramadol

Interventions

Buprenorphine DRUG

Buprenorphine

Tramadol DRUG

Tramadol

Eligibility Criteria

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

You may qualify if:

• Males and females aged 18 years or more (women of childbearing potential must have a negative pregnancy test, be non-lactating, and willing to use adequate and reliable contraception (defined as IUD, contraceptive pill or depot gestagen) throughout the study) with osteoarthritis in the hip \&/or knee.
• Or Males \& females aged 50 years or more with osteoarthritis in lumbar spine without nerve root pressure.
• Clinical diagnosis of OA in the hip and/or knee including fulfilment of ACR-criteria and radiographic or MR-Scan evidence for the primary OA-joint in hip \&/or knee.
• Or Clinical diagnosis of OA in the lumbar spine without nerve root pressure, \& with radiographic or CT-scan evidence for lumbar OA.
• Subjects with moderate to severe pain confirmed by a BS-11 score \> 4 for their pain on average in their primary OA-joint during the last 5 days prior to the Baseline Visit (Randomisation Visit/Visit 4).
• Subjects must previously or during Wash-out-Phase have been treated with 4000 mg Paracetamol IR daily or another analgesic treatment at least comparable to this and not have been adequately pain relieved (defined as BS-11 score \> 4 for their pain on average in their Primary OA-joint during 5 continuous days) on that treatment.
• Subjects must be willing to discontinue all other analgesics (incl. glucosamine) at the Pre-Screening Visit (Visit 1) and until the Completion/Discontinuation Visit (Visit 10).
• Subjects must be able to read and comprehend Danish and be willing to sign informed consent.
• Subjects must be willing and able to fill in a Subject Diary on a daily basis.

You may not qualify if:

• Subjects treated with high-potent opioid analgesics (e.g. morphine, fentanyl, oxycodone, methadone, hydromorphone, ketobemidone, buprenorphine (incl. Norspan® patches)) for their OA pain. Except subjects treated with high-potent opioid analgesics for up to four continuous weeks for their OA pain beyond 3 months prior to the Pre-screening Visit.
• Subjects treated with high-potent opioid analgesics (e.g. morphine, fentanyl, oxycodone, methadone, hydromorphone, ketobemidone, buprenorphine (incl. Norspan® patches)) within four weeks prior to the Pre-screening Visit due to non-OA pain.
• Subjects treated with more than 200 mg Tramadol daily or 200 mg codeine daily during the last two weeks prior to the Pre-screening Visit.
• History of chronic condition(s), in addition to OA, requiring frequent analgesic therapy (e.g. frequent headaches, frequent migraine, gout, rheumatoid arthritis) and severe respiratory disease.
• Scheduled for surgery that would fall within all phases (Run-in-Phase, Wash-out-Phase, Double-Blind-Phase and Follow-up-Phase) of the study.
• Substance or alcohol abuse, or subjects who, in the opinion of the Investigator, have demonstrated addictive or substance abuse behaviour.
• Subjects with cancer (except basal cell carcinoma) or history of cancer in the last 5 years (except treated basal cell carcinoma).
• Untreated depression or other psychiatric disorder in such a way that participation in the study may, in the opinion of the Investigator, pose an unacceptable risk to the subject.
• Dermatological disorder at any relevant patch application site that precludes proper placement and/or rotation of patch placement.
• Treatment with steroids (oral, intra-muscular, intra-venous, intra-articular, epidural, or other corticosteroid injections) within 6 weeks prior to the Pre-screening Visit and during the study.
• Intra-articular hyaluron acid injections given within 6 months prior to the Pre-screening Visit and during the study.
• Any joint evacuation carried out within 6 weeks prior to the Pre-screening Visit and during the study.
• Subjects who are currently taking monoamine oxidase inhibitors (MAOIs) or have taken MAOIs within 2 weeks prior to the Pre-screening Visit.
• Participation in a clinical research study involving a new chemical entity within 3 months prior to the Pre-screening Visit.
• Allergies or other contraindications to transdermal systems or patch adhesives.

Sponsors & Collaborators

• Norpharma A/S: lead
• Mundipharma Finland: collaborator

Study Sites (1)

Dr. Olavi Airaksinen

Oma Lääkäri Oy, Vuorikatu 20, Kuopio, FIN-70100, Finland

Location

MeSH Terms

Conditions

Osteoarthritis; Pain

Interventions

Buprenorphine; Tramadol

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; 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; Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Dimethylamines; Methylamines; Amines; Lipids

Study Officials

• Dorthe Tvinnemose, DVM

  Norpharma A/S, Slotsmarken 15, DK-2970 Hoersholm, Denmark

  STUDY DIRECTOR

• Kim H Kristiansen, DM

  GP, Noerretorv 10, DK-7200 Grindsted, Denmark

  PRINCIPAL INVESTIGATOR

• Olavi Airaksinen, DM

  Oma Lääkäri Oy, Vuorikatu 20, FIN-70100 KUOPIO

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 23, 2007
• First Posted: January 25, 2007
• Study Start: February 1, 2007
• Primary Completion: July 1, 2009
• Study Completion: August 1, 2009
• Last Updated: February 1, 2010

Record last verified: 2010-01

Locations

FI (1)