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: March 26, 2015
Last verified: March 2015
Results First Received: June 20, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Basic Science
Condition: Osteoarthritis, Knee
Interventions: Drug: Paracetamol
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Study was conducted at a single centre in Spain.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Out of 33 screened participants, 31 were randomized, while 2 participants were considered as screen failures

Reporting Groups
  Description
Sequence 1 Participants took part in 3 study sessions. Session 1-participant took two 665 mg sustained release paracetamol formulations orally with 150 ml water. Four consecutive doses were administered every 8h, with the first dose (0h) and last dose (24h) under supervision at clinic and the second dose (8h) and third dose (16h) self-administered. Session 2-no treatment was given. Session 3-participant took two caplets of matched placebo orally with 150 ml water. Four consecutive doses were administered every 8h, with the first dose (0h) and last dose (24h) under supervision at clinic and the second dose (8h) and third dose (16h) self-administered. A 5-14 day washout was given after session 1 and session 2. A 7-14 day follow-up was done after session 3.
Sequence 2 Participants took part in 3 study sessions. Session 1-participants took two caplets of matched placebo orally with 150 ml water. Four consecutive doses were administered every 8h, with the first dose (0h) and last dose (24h) under supervision at clinic and the second dose (8h) and third dose (16h) self-administered. Session 2-no treatment was given. Session 3-participant took two 665 mg sustained release paracetamol formulations orally with 150 ml water. Four consecutive doses were administered every 8h, with the first dose (0h) and last dose (24h) under supervision at clinic and the second dose (8h) and third dose (16h) self-administered. A 5-14 day washout was given after session 1 and session 2. A 7-14 day follow-up was done after session 3.
Sequence 3 Participants took part in 3 study sessions. Session 1-no treatment was given. Session 2-participant took two 665 mg sustained release paracetamol formulations orally with 150 ml water. Four consecutive doses were administered every 8h, with the first dose (0h) and last dose (24h) under supervision at clinic and the second dose (8h) and third dose (16h) self-administered. Session 3-participants took two caplets of matched placebo orally with 150 ml water. Four consecutive doses were administered every 8h, with the first dose (0h) and last dose (24h) under supervision at clinic and the second dose (8h) and third dose (16h) self-administered.A 5-14 day washout was given after session 1 and session 2. A 7-14 day follow-up was done after session 3.
Sequence 4 Participants took part in 3 study sessions. Session 1-no treatment was given. Session 2-participants took two caplets of matched placebo orally with 150 ml water. Four consecutive doses were administered every 8h, with the first dose (0h) and last dose (24h) under supervision at clinic and the second dose (8h) and third dose (16h) self-administered. Session 3-participant took two 665 mg sustained release paracetamol formulations orally with 150 ml water. Four consecutive doses were administered every 8h, with the first dose (0h) and last dose (24h) under supervision at clinic and the second dose (8h) and third dose (16h) self-administered. A 5-14 day washout was given after session 1 and session 2. A 7-14 day follow-up was done after session 3.

Participant Flow for 5 periods

Period 1:   Period 1
    Sequence 1     Sequence 2     Sequence 3     Sequence 4  
STARTED     8     8     7     8  
COMPLETED     8     8     7     7  
NOT COMPLETED     0     0     0     1  
Adverse Event                 0                 0                 0                 1  

Period 2:   Wash-out Period 1
    Sequence 1     Sequence 2     Sequence 3     Sequence 4  
STARTED     8     8     7     7  
COMPLETED     8     8     7     7  
NOT COMPLETED     0     0     0     0  

Period 3:   Period 2
    Sequence 1     Sequence 2     Sequence 3     Sequence 4  
STARTED     8     8     7     7  
COMPLETED     7     8     7     7  
NOT COMPLETED     1     0     0     0  
Adverse Event                 1                 0                 0                 0  

Period 4:   Wash-out Period 2
    Sequence 1     Sequence 2     Sequence 3     Sequence 4  
STARTED     7     8     7     7  
COMPLETED     7     8     7     7  
NOT COMPLETED     0     0     0     0  

Period 5:   Period 3
    Sequence 1     Sequence 2     Sequence 3     Sequence 4  
STARTED     7     8     7     7  
COMPLETED     7     6     7     7  
NOT COMPLETED     0     2     0     0  
Protocol Violation                 0                 2                 0                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Total Participants for Baseline Measurement All randomized participants except one were evaluated for baseline measures. One participant had misallocated treatments that could not be determined. Therefore, this participant was excluded from all populations including safety.

Baseline Measures
    Total Participants for Baseline Measurement  
Number of Participants  
[units: participants]
  30  
Age, Customized  
[units: Years]
Mean (Standard Deviation)
 
Years     68.5  (7.97)  
Gender  
[units: Participants]
 
Female     26  
Male     4  



  Outcome Measures
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1.  Primary:   Blood Oxygen Level-Dependent (BOLD) Response in the Tibio-femoral Joint of Knee Osteoarthritis (OA): [BOLD (T-f)]   [ Time Frame: Baseline to 2-5 hours post last dose administration ]

2.  Secondary:   BOLD Response in the Patello-femoral Joint of Knee Osteoarthritis: [BOLD (P-f)]   [ Time Frame: Baseline to 2-5 hours post last dose administration ]

3.  Secondary:   Subjective Numerical Rating Scale (NRS) Response for Treatment Effect on OA Knee Before Stimulation: [NRS (TRT)]   [ Time Frame: Baseline and post-dose before stimulus ]

4.  Secondary:   Subjective NRS Response for Treatment Effect on Tibio-femoral Stimulation Prior the fMRI Scan: [NRS (T-f Pre-scan)]   [ Time Frame: Baseline and post-dose pre-scan after stimulus ]

5.  Secondary:   Subjective NRS Response for Treatment Effect on Patello-femoral Stimulation Prior the fMRI Scan: [NRS (P-f Pre-scan)]   [ Time Frame: Baseline and post-dose pre-scan after stimulus ]

6.  Secondary:   Subjective NRS Response for Treatment Effect on Tibio-femoral Stimulation After the fMRI Scan: [NRS (T-f Post-scan)]   [ Time Frame: Baseline and post-dose post-scan after stimulus ]

7.  Secondary:   Subjective NRS Response for Treatment Effect on Patello-femoral Stimulation After the fMRI Scan: [NRS (P-f Post-scan)]   [ Time Frame: Baseline and post-dose post-scan after stimulus ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343



Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01105936     History of Changes
Other Study ID Numbers: A3360529
Study First Received: March 4, 2010
Results First Received: June 20, 2013
Last Updated: March 26, 2015
Health Authority: Spain: Agencia Española del Medicamento y Productos Sanitarios