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Fentanyl Administered Intraorally for Rapid Treatment of Orthopedic Pain (FAIRTOP)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00685295
First Posted: May 28, 2008
Last Update Posted: February 9, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Stephen H. Thomas, MD MPH, Massachusetts General Hospital
Results First Submitted: February 25, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Pain, Fracture, Sprain
Interventions: Drug: Fentanyl
Drug: Lansoprazole
Drug: Oxycodone

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Arm 1 / Fentora Subject receives placebo swallowed pill, and Fentora 100mcg rapidly dissolving transbuccal tablet
Arm 2 / Percocet/Prevacid Subject receives Percocet swallowed pill, and Prevacid comparator rapidly dissolving transbuccal tablet

Participant Flow:   Overall Study
    Arm 1 / Fentora   Arm 2 / Percocet/Prevacid
STARTED   30   30 
COMPLETED   30   30 
NOT COMPLETED   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
Arm 1 / Fentora Subject receives placebo swallowed pill, and Fentora 100mcg rapidly dissolving transbuccal tablet
Arm 2 / Percocet/Prevacid Subject receives Percocet swallowed pill, and Prevacid comparator rapidly dissolving transbuccal tablet
Total Total of all reporting groups

Baseline Measures
   Arm 1 / Fentora   Arm 2 / Percocet/Prevacid   Total 
Overall Participants Analyzed 
[Units: Participants]
 30   30   60 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      30 100.0%      30 100.0%      60 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 29  (8)   30  (12)   30  (10) 
Gender 
[Units: Participants]
Count of Participants
     
Female      10  33.3%      12  40.0%      22  36.7% 
Male      20  66.7%      18  60.0%      38  63.3% 
Region of Enrollment 
[Units: Participants]
     
United States   30   30   60 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Time to Analgesia   [ Time Frame: 60 minutes ]

2.  Primary:   Pain Reduction   [ Time Frame: 60 minutes ]

3.  Secondary:   Occurrence of Untoward Opioid Side Effects   [ Time Frame: 120 minutes ]


  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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Stephen Thomas
Organization: Harvard/MGH
phone: 6177267622
e-mail: sthomasmd@gmail.com



Responsible Party: Stephen H. Thomas, MD MPH, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00685295     History of Changes
Other Study ID Numbers: FAIRTOP
First Submitted: May 23, 2008
First Posted: May 28, 2008
Results First Submitted: February 25, 2009
Results First Posted: February 9, 2017
Last Update Posted: February 9, 2017