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)

NCT01105936 | Completed Phase 4 Results

• 1 other identifier: A3360529
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Osteoarthritis, Knee

Keywords

osteoarthritis; pain; paracetamol; Blood-Oxygen-Level-Dependent functional magnetic resonance imaging

Outcome Measures

Primary Outcomes (1)

• Blood Oxygen Level-Dependent (BOLD) Response in the Tibio-femoral Joint of Knee Osteoarthritis (OA): [BOLD (T-f)]

  BOLD response to painful pressure stimuli was evaluated using fMRI. Voxel-wise BOLD scores were reported on a Z-scale (Gaussian,mean=0,SD=1); range -3 (worst score, lowest connectivity) to +3 (best score, highest connectivity). The software derived scores compared the intensity reading in the region to a template, specifically the Montreal Neurological Institute (MNI) Echo-Planar Image (EPI) template. The template provides, for each region, expected (mean/median) intensity for that region, along with expected variation. The BOLD score on the Z-scale represents how far the actual measured intensity is from the expected in the template. A score of 0 would correspond to the mean/median, a score of 1.65 would represent the 90-percentile, -1.65 the 10-percentile, and so on, according to a standard normal distribution.

  Baseline to 2-5 hours post last dose administration

Secondary Outcomes (6)

• BOLD Response in the Patello-femoral Joint of Knee Osteoarthritis: [BOLD (P-f)]

  Baseline to 2-5 hours post last dose administration

• Subjective Numerical Rating Scale (NRS) Response for Treatment Effect on OA Knee Before Stimulation: [NRS (TRT)]

  Baseline and post-dose before stimulus

• Subjective NRS Response for Treatment Effect on Tibio-femoral Stimulation Prior the fMRI Scan: [NRS (T-f Pre-scan)]

  Baseline and post-dose pre-scan after stimulus

• Subjective NRS Response for Treatment Effect on Patello-femoral Stimulation Prior the fMRI Scan: [NRS (P-f Pre-scan)]

  Baseline and post-dose pre-scan after stimulus

• Subjective NRS Response for Treatment Effect on Tibio-femoral Stimulation After the fMRI Scan: [NRS (T-f Post-scan)]

  Baseline and post-dose post-scan after stimulus

Study Arms (2)

Paracetamol caplets

EXPERIMENTAL

Two 665 mg sustained release paracetamol caplets administered orally with water.

Drug: Paracetamol

Placebo caplets

PLACEBO COMPARATOR

Two placebo caplets administered orally with water.

Drug: Placebo

Interventions

Paracetamol DRUG

665 mg sustained release paracetamol caplets

Paracetamol caplets

Placebo DRUG

Placebo caplets

Placebo caplets

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

Hospital Del Mar

Barcelona, CP: 08003, Spain

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis; Pain

Interventions

Acetaminophen

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2010
• First Posted: April 19, 2010
• Study Start: September 1, 2010
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: June 21, 2017
• Results First Posted: March 24, 2015

Record last verified: 2017-05

Locations

ES (1)