Assess the Blood-Oxygen-Level-Dependent (BOLD) Signal Changes in the Brain by Paracetamol as Measured by Functional Magnetic Resonance Imaging (fMRI) in Subjects With Osteoarthritis (OA)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01105936
First received: March 4, 2010
Last updated: April 11, 2013
Last verified: April 2013
  Purpose

Blood-Oxygen-Level-Dependent (BOLD) responses to painful mechanical stimulation of the OA knee following treatment with four consecutive doses (at 8 hour intervals) on giving sustained released paracetamol treatment or placebo will be compared. The fMRI and pain assessments will occur approximately 2-5 hours after taking the final dose.


Condition Intervention Phase
Osteoarthritis, Knee
Drug: Paracetamol
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: A Randomised, Double-blind, Evaluation of the Effects of Paracetamol on the BOLD fMRI Response to Painful Stimuli in Subjects With Osteoarthritis

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Blood Oxygen Level-Dependent (BOLD) response in the tibio-femoral joint of knee osteoarthritis (OA): [BOLD (t-f)] [ Time Frame: Approximately 2-5 hours after taking the fourth assigned dose ] [ Designated as safety issue: No ]
    BOLD response to mechanical stimulation (painful pressure stimuli) was evaluated in the tibio-femoral joint of the knee osteoarthritis using functional magnetic response imaging (fMRI) through images. Mean (SD) for tibio-femoral response were not reported because there were no significant differences found in any region of the brain from the BOLD response due to mechanical stimuli in this joint.


Secondary Outcome Measures:
  • BOLD response in the patello-femoral joint of knee osteoarthritis: [BOLD (p-f)] [ Time Frame: Approximately 2-5 hours after taking the fourth assigned dose ] [ Designated as safety issue: No ]
    BOLD response to mechanical stimulation (painful pressure stimuli) was evaluated in the patello-femoral joint of the knee osteoarthritis using functional magnetic response imaging (fMRI).

  • Subjective numerical rating scale (NRS) response for treatment effect on OA knee before stimulation: [NRS (TRT)] [ Time Frame: Approximately 2-5 hours after taking the fourth assigned dose ] [ Designated as safety issue: No ]
    Subjective NRS response for each participant was calculated as difference of pre-treatment NRS pain assessment before stimulus and post-treatment NRS pain assessment before stimulus. NRS responses was based on an 11 scale rating (0-10), with 0 corresponding to "No Pain" and 10 corresponding to "Extreme Pain or Pain as bad as you can imagine".

  • Subjective NRS response for treatment effect on tibio-femoral stimulation prior the fMRI scan: [NRS (t-f Pre-scan)] [ Time Frame: Approximately 2-5 hours after taking the fourth assigned dose ] [ Designated as safety issue: No ]
    Subjective NRS response was calculated for each participant as difference of pre-treatment pain assessment after stimulus and post-treatment pre-scan pain assessment after stimulus on tibio-femoral joint. NRS responses was based on an 11 scale rating (0-10), with 0 corresponding to "No Pain" and 10 corresponding to "Extreme Pain or Pain as bad as you can imagine".

  • Subjective NRS response for treatment effect on patello-femoral stimulation prior the fMRI scan: [NRS (p-f Pre-scan)] [ Time Frame: Approximately 2-5 hours after taking the fourth assigned dose ] [ Designated as safety issue: No ]
    Subjective NRS response was calculated for each participant as difference of pre-treatment pain assessment after stimulus and post-treatment pre-scan pain assessment after stimulus on patello-femoral. NRS responses was based on an 11 scale rating (0-10), with 0 corresponding to "No Pain" and 10 corresponding to "Extreme Pain or Pain as bad as you can imagine".

  • Subjective NRS response for treatment effect on tibio-femoral stimulation after the fMRI scan: [NRS (t-f Post-scan)] [ Time Frame: Approximately 2-5 hours after taking the fourth assigned dose ] [ Designated as safety issue: No ]
    Subjective NRS response for treatment effect on tibio-femoral stimulus after the fMRI scan was calculated for each participant as difference of pre-treatment pain assessment after stimulus and post-treatment post-scan pain assessment after stimulus on tibio-femoral. NRS responses was based on an 11 scale rating (0-10), with 0 corresponding to "No Pain" and 10 corresponding to "Extreme Pain or Pain as bad as you can imagine".

  • Subjective NRS response for treatment effect on patello-femoral stimulation after the fMRI scan: [NRS (p-f Post-scan)] [ Time Frame: Approximately 2-5 hours after taking the fourth assigned dose ] [ Designated as safety issue: No ]
    Subjective NRS response for each participant for treatment effect on tibio-femoral stimulus after the fMRI scan was calculated as difference of pre-treatment pain assessment after stimulus and post-treatment post-scan pain assessment after stimulus on patello-femoral. NRS responses was based on an 11 scale rating (0-10), with 0 corresponding to "No Pain" and 10 corresponding to "Extreme Pain or Pain as bad as you can imagine".


Enrollment: 31
Study Start Date: September 2010
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Paracetamol caplets
Two 665 mg sustained release paracetamol caplets administered orally with water.
Drug: Paracetamol
665 mg sustained release paracetamol caplets
Placebo Comparator: Placebo caplets
Two placebo caplets administered orally with water.
Drug: Placebo
Placebo caplets

Detailed Description:

The objective of this study is to investigate if functional magnetic response imaging (fMRI) can detect the effects of a known pain medicine at over-the-counter doses in people with osteoarthritis (OA) of the knee. The fMRI is a harmless and painless technique that is used in the current study to collect images of brain activity to see if is changed when feeling pain. In this study, BOLD response to mechanical stimulation via pressure stimuli applied to the tibio-femoral joint and patello-femoral in participants with knee OA following four treatment doses of any of three treatment will be compared.

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of osteoarthritis of at least one knee for 3 months
  • Male or female at least 45 years of age
  • Score a minimum of 4 out of 10 on the numerical pain rating and a maximum of 8 at screening

Exclusion Criteria:

  • If female, is pregnant, lactating, or breast feeding
  • Has secondary cause of knee arthritis
  • Lower extremity surgery in the last 6 months
  • Prior injury in the last twelve months to the index knee
  • Used any analgesics (NSAIDs, COX2 inhibitor, etc) within 5 half lives of study start
  • Recently used oral or injected glucocorticoids
  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: NCT01105936

Locations
Spain
Hospital Del Mar
Barcelona, Spain, CP: 08003
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01105936     History of Changes
Other Study ID Numbers: A3360529
Study First Received: March 4, 2010
Last Updated: April 11, 2013
Health Authority: Spain: Agencia Española del Medicamento y Productos Sanitarios

Keywords provided by GlaxoSmithKline:
osteoarthritis
pain
paracetamol
Blood-Oxygen-Level-Dependent functional magnetic resonance imaging

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Acetaminophen
Antipyretics
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 26, 2014