NCT01276431

Brief Summary

An open label, multi-centre, prospective age-group-controlled study to evaluate efficacy and safety of buprenorphine transdermal patches in subjects with chronic, moderate to severe osteoarthritis pain of the hip and/or knee.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Mar 2011

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 10, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 13, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2011

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

February 6, 2014

Status Verified

February 1, 2014

Enrollment Period

1.4 years

First QC Date

January 10, 2011

Last Update Submit

February 5, 2014

Conditions

Osteoarthritis Pain of the Hip and or Knee

Outcome Measures

Primary Outcomes (1)

  • Box Scale-11 (BS-11) pain scores (pain on average during the last seven days, mean change from Baseline to Completion (fulfilled all visits in the study).

Secondary Outcomes (6)

  • Western Ontario & McMaster Universities OA Index

  • European QOL Health Questionnaire

  • Sleep disturbance & quality of sleep questions

  • Patients global assessment of pain relief

  • Investigators global assessment of pain relief

  • +1 more secondary outcomes

Study Arms (1)

Buprenorphine transdermal patch

OTHER

For two age groups: 50-60 years and \>= 75 years of age

Drug: Buprenorphine transdermal patch

Interventions

Buprenorphine transdermal patchDRUG
Buprenorphine transdermal patch

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males and females aged 50-60 or ≥ 75 years.
  • Subjects with clinical diagnosis of osteoarthritis in knee and/or hip including fulfilment of ACR-criteria and radiographic evidence not older than one year.
  • Subjects with a moderate to severe pain, confirmed by a BS-11 score ≥ 4 for their pain on average during the last seven days of the Screening Phase in their primary OA-site at the Baseline Visit.

You may not qualify if:

  • Subjects recording \< 4 on average during the Screening Phase on the BS-11 scale.
  • Subjects treated with high-potent opioid analgesics (e.g. morphine, fentanyl, oxycodone, methadone, hydromorphone, ketobemidone, buprenorphine) for their osteoarthritis pain.
  • Subjects treated with a regular dose for \> 1 week of tramadol, codeine or dextropropoxyphene within 1 month before screening visit.
  • Subjects who require NSAID treatment (except aspirin for cardiovascular indications) or cox-2-inhibitors during the study period.
  • Subjects with history of, or ongoing, chronic condition(s), in addition to osteoarthritis, requiring frequent analgesic therapy (e.g. frequent headaches, frequent migraine, gout, rheumatoid arthritis).
  • Subjects scheduled for surgery that would fall within the study period.
  • Subjects who currently abused substance or alcohol, or subjects who, in the opinion of the Investigator, have demonstrated addictive or substance abuse behaviours.
  • 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 way that participation in the study may, in the opinion of the Investigator, pose an unacceptable risk to the subject.
  • Subjects who are currently taking hypnotics, anxiolytics or other central nervous system depressants that, in the Investigator's opinion, may pose a risk of additional CNS depression with study medication.
  • Subjects who are currently taking adjuvant analgesics such as antidepressants and anti-convulsants.
  • Dermatological disorder or non-intact skin at any relevant patch application site that precludes proper placement and/or rotation of patch placement.
  • Subjects who had received an intra-articular steroid injection within 6 weeks prior Screening Visit or subjects who require steroid treatment (oral, intra-muscular, intra-venous, intra-articular, epidural or other corticosteroid injections) during the study period.
  • Subjects with joint evacuation 6 weeks prior Screening Visit and during the study.
  • Subjects who are currently taking monoamine oxidase inhibitors (MAOI's) or have taken MAOI's within 2 weeks before Screening Visit.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Professor Jon Karlsson

Mölndal, Sweden

Location

Dr Bengt Olav Tengmark

Stockholm, Sweden

Location

Related Publications (1)

  • Karlsson J, Soderstrom A, Augustini BG, Berggren AC. Is buprenorphine transdermal patch equally safe and effective in younger and elderly patients with osteoarthritis-related pain? Results of an age-group controlled study. Curr Med Res Opin. 2014 Apr;30(4):575-87. doi: 10.1185/03007995.2013.873714. Epub 2013 Dec 23.

    PMID: 24320787BACKGROUND

Study Design

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

Study Record Dates

First Submitted

January 10, 2011

First Posted

January 13, 2011

Study Start

March 1, 2011

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

February 6, 2014

Record last verified: 2014-02

Locations

SE(2)