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Functional Dyspepsia Treatment Trial (FDTT)

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ClinicalTrials.gov Identifier: NCT00248651
Recruitment Status : Completed
First Posted : November 4, 2005
Results First Posted : July 25, 2014
Last Update Posted : July 25, 2014
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Yuri A. Saito Loftus, Mayo Clinic

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition: Dyspepsia and Other Specified Disorders of Function of Stomach
Interventions: Drug: Amitriptyline
Drug: Escitalopram
Drug: Placebo

  Participant Flow

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

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 
Overall Participants Analyzed 
[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

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 ]
  Show Outcome Measure 2

3.  Secondary:   Maximum Tolerated Volume by Nutrient Drink Test   [ Time Frame: 12 weeks ]
  Show Outcome Measure 3

4.  Secondary:   Dyspepsia-Specific Quality of Life   [ Time Frame: 12 Weeks ]
  Show Outcome Measure 4


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
No text entered.


  More Information

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 ( U.S. NIH Grant/Contract )
First Submitted: November 3, 2005
First Posted: November 4, 2005
Results First Submitted: June 26, 2014
Results First Posted: July 25, 2014
Last Update Posted: July 25, 2014