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Functional Dyspepsia Treatment Trial (FDTT)

This study has been completed.
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Yuri A. Saito Loftus, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00248651
First received: November 3, 2005
Last updated: June 26, 2014
Last verified: June 2014
History of Changes
Results First Received: June 26, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Dyspepsia and Other Specified Disorders of Function of Stomach
Interventions: Drug: Amitriptyline
Drug: Escitalopram
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 enrollment was during October 27, 2006 to February 11, 2013.

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
Amitriptyline Amitriptyline capsule (50 mg) plus a placebo escitalopram tablet will be taken at night half an hour before bedtime. To maximize patient tolerability, in the first 2 weeks the dose of amitriptyline will be 25 mg and then the dose will be increased to 50 mg, but the 25 mg and 50 mg capsules will be indistinguishable to maintain blinding.
Escitalopram Escitalopram tablet (10 mg) plus a placebo amitriptyline capsule will be taken by mouth at night half an hour before bedtime for 12 weeks.
Placebo Placebo escitalopram tablets and placebo amitriptyline capsules will be taken by mouth half an hour before bedtime for 12 weeks.

Participant Flow:   Overall Study
    Amitriptyline     Escitalopram     Placebo  
STARTED     97     98     97  
Completed 12 Weeks of Treatment     78     66     75  
COMPLETED     69     58     65  
NOT COMPLETED     28     40     32  
Withdrawal by Subject                 28                 40                 32  



  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
Amitriptyline Amitriptyline capsule (50 mg) plus a placebo escitalopram tablet will be taken at night half an hour before bedtime. To maximize patient tolerability, in the first 2 weeks the dose of amitriptyline will be 25 mg and then the dose will be increased to 50 mg, but the 25 mg and 50 mg capsules will be indistinguishable to maintain blinding.
Escitalopram Escitalopram tablet (10 mg) plus a placebo amitriptyline capsule will be taken by mouth at night half an hour before bedtime for 12 weeks.
Placebo Placebo escitalopram tablets and placebo amitriptyline capsules will be taken by mouth half an hour before bedtime for 12 weeks.
Total Total of all reporting groups

Baseline Measures
    Amitriptyline     Escitalopram     Placebo     Total  
Number of Participants  
[units: participants]
 		  97     98     97     292  
Age  
[units: years]
Mean (Standard Deviation) 		  43  (15)     45  (15)     45  (16)     44  (15)  
Gender  
[units: participants]
 		       
Female     74     72     73     219  
Male     23     26     24     73  
Region of Enrollment  
[units: participants]
 		       
United States     94     94     96     284  
Canada     3     4     1     8  



  Outcome Measures
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1.  Primary:   Self-Report of Adequate Relief of Dyspepsia (Yes/No) For at Least 50% of Weeks 3 -12 of Treatment   [ Time Frame: 3 weeks through 12 weeks ]
  Show Outcome Measure 1

2.  Secondary:   Gastric Emptying Half-Time (T1/2)   [ Time Frame: 12 weeks ]
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3.  Secondary:   Maximum Tolerated Volume by Nutrient Drink Test   [ Time Frame: 12 weeks ]
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4.  Secondary:   Dyspepsia-Specific Quality of Life   [ Time Frame: 12 Weeks ]
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  Serious Adverse Events
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  Other Adverse Events
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  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 NOT 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.


Results Point of Contact:  
Name/Title: Dr. Yuri A. Saito Loftus
Organization: Mayo Clinic
phone: 507-266-9094
e-mail: saito.yuri@mayo.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):


Responsible Party: Yuri A. Saito Loftus, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00248651     History of Changes
Obsolete Identifiers: NCT00275626
Other Study ID Numbers: 2021-05 (DK065713)
U01DK065713 ( US NIH Grant/Contract Award Number )
Study First Received: November 3, 2005
Results First Received: June 26, 2014
Last Updated: June 26, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada