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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Stephen H. Thomas, MD MPH, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00685295
First received: May 23, 2008
Last updated: December 17, 2016
Last verified: December 2016
Results First Received: February 25, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (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
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

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
Study First Received: May 23, 2008
Results First Received: February 25, 2009
Last Updated: December 17, 2016