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Trial record 55 of 135 for:    AMITRIPTYLINE

Functional Dyspepsia Treatment Trial (FDTT)

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.
 
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
Enrollment 292
Recruitment Details Study enrollment was during October 27, 2006 to February 11, 2013.
Pre-assignment Details  
Arm/Group Title Amitriptyline Escitalopram Placebo
Hide Arm/Group Description 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 tablet (10 mg) plus a placebo amitriptyline capsule will be taken by mouth at night half an hour before bedtime for 12 weeks. Placebo escitalopram tablets and placebo amitriptyline capsules will be taken by mouth half an hour before bedtime for 12 weeks.
Period Title: Overall Study
Started 97 98 97
Completed 12 Weeks of Treatment 78 66 75
Completed 69 58 65
Not Completed 28 40 32
Reason Not Completed
Withdrawal by Subject             28             40             32
Arm/Group Title Amitriptyline Escitalopram Placebo Total
Hide Arm/Group Description 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 tablet (10 mg) plus a placebo amitriptyline capsule will be taken by mouth at night half an hour before bedtime for 12 weeks. Placebo escitalopram tablets and placebo amitriptyline capsules will be taken by mouth half an hour before bedtime for 12 weeks. Total of all reporting groups
Overall Number of Baseline Participants 97 98 97 292
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 97 participants 98 participants 97 participants 292 participants
43  (15) 45  (15) 45  (16) 44  (15)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 97 participants 98 participants 97 participants 292 participants
Female
74
  76.3%
72
  73.5%
73
  75.3%
219
  75.0%
Male
23
  23.7%
26
  26.5%
24
  24.7%
73
  25.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 97 participants 98 participants 97 participants 292 participants
United States 94 94 96 284
Canada 3 4 1 8
1.Primary Outcome
Title Self-Report of Adequate Relief of Dyspepsia (Yes/No) For at Least 50% of Weeks 3 -12 of Treatment
Hide Description The first two weeks of treatment were excluded to allow for establishment of steady state drug levels.
Time Frame 3 weeks through 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat analysis included all randomized subjects.
Arm/Group Title Amitriptyline Escitalopram Placebo
Hide Arm/Group Description:
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 tablet (10 mg) plus a placebo amitriptyline capsule will be taken by mouth at night half an hour before bedtime for 12 weeks.
Placebo escitalopram tablets and placebo amitriptyline capsules will be taken by mouth half an hour before bedtime for 12 weeks.
Overall Number of Participants Analyzed 97 98 97
Measure Type: Number
Unit of Measure: percentage of participants
53 38 40
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Amitriptyline, Escitalopram, Placebo
Comments Overall treatment effect from logistic regression model incorporating balancing factors. A p-value of <0.05 was considered statistically significant.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
2.Secondary Outcome
Title Gastric Emptying Half-Time (T1/2)
Hide Description The time for half of the ingested solids or liquids to leave the stomach.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat analysis included all randomized subjects.
Arm/Group Title Amitriptyline Escitalopram Placebo
Hide Arm/Group Description:
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 tablet (10 mg) plus a placebo amitriptyline capsule will be taken by mouth at night half an hour before bedtime for 12 weeks.
Placebo escitalopram tablets and placebo amitriptyline capsules will be taken by mouth half an hour before bedtime for 12 weeks.
Overall Number of Participants Analyzed 97 98 97
Mean (Standard Deviation)
Unit of Measure: minutes
117  (43) 108  (36) 115  (40)
3.Secondary Outcome
Title Maximum Tolerated Volume by Nutrient Drink Test
Hide Description The nutrient drink test for meal-induced satiety had subjects drink 120 ml of ENSURE every four minutes. Satiety scores were measured on a scale graded 0-5 (1, no symptoms; 5, maximum satiety). When a score of 5 was reached, the maximum tolerated volume intake was measured. Abnormal satiety was defined as inability to consume > 800 ml of Ensure.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat analysis included all randomized subjects.
Arm/Group Title Amitriptyline Escitalopram Placebo
Hide Arm/Group Description:
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 tablet (10 mg) plus a placebo amitriptyline capsule will be taken by mouth at night half an hour before bedtime for 12 weeks.
Placebo escitalopram tablets and placebo amitriptyline capsules will be taken by mouth half an hour before bedtime for 12 weeks.
Overall Number of Participants Analyzed 97 98 97
Mean (Standard Deviation)
Unit of Measure: ml
764  (319) 823  (391) 839  (442)
4.Secondary Outcome
Title Dyspepsia-Specific Quality of Life
Hide Description The Nepean Dyspepsia Index (NDI) assessed quality of life. NDI scores are summarized into overall quality of life and 5 subscales: Interference, Knowledge/Control, Eating/Drinking, Sleep Disturbance, Work/Study. The scale consists of 25 items, yielding 5 sub-scales. Range 0-100, higher numbers indicate a greater quality of life.
Time Frame 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat analysis included all randomized subjects.
Arm/Group Title Amitriptyline Escitalopram Placebo
Hide Arm/Group Description:
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 tablet (10 mg) plus a placebo amitriptyline capsule will be taken by mouth at night half an hour before bedtime for 12 weeks.
Placebo escitalopram tablets and placebo amitriptyline capsules will be taken by mouth half an hour before bedtime for 12 weeks.
Overall Number of Participants Analyzed 97 98 97
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Overall Quality of Life
80.6
(76.2 to 85.0)
82.8
(78.4 to 87.1)
73.5
(69.1 to 77.8)
Interference Subscale
83.2
(78.3 to 88.2)
82.8
(78.4 to 87.1)
76.2
(70.9 to 81.5)
Knowledge/Control Subscale
78.2
(73.2 to 83.2)
76.2
(71.3 to 81.1)
72.9
(68.2 to 77.6)
Eat/Drink Subscale
72.4
(66.7 to 78.0)
70.6
(65.4 to 75.6)
64.8
(59.6 to 70.1)
Sleep Disturbance Subscale
86.3
(81.6 to 91.0)
80.8
(75.2 to 86.3)
76.4
(70.9 to 81.8)
Work/Study Subscale
86.9
(82.6 to 91.1)
87.2
(83.5 to 90.9)
79.7
(74.5 to 84.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Amitriptyline, Escitalopram, Placebo
Comments Comparison between antidepressant arms and placebo for overall quality of life. A p-value of <0.05 was considered statistically significant.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.02
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Amitriptyline, Escitalopram, Placebo
Comments Comparison between antidepressant arms and placebo for Eat/Drink subscale. A p-value of <0.05 was considered statistically significant.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.06
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Amitriptyline, Escitalopram, Placebo
Comments Comparison between antidepressant arms and placebo for Interference subscale. A p-value of <0.05 was considered statistically significant.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.06
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Amitriptyline, Escitalopram, Placebo
Comments Comparison between antidepressant arms and placebo for Sleep Disturbance subscale. A p-value of <0.05 was considered statistically significant.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.01
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Amitriptyline, Escitalopram, Placebo
Comments Comparison between antidepressant arms and placebo for Work/Study subscale. A p-value of <0.05 was considered statistically significant.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.04
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Amitriptyline Escitalopram Placebo
Hide Arm/Group Description 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 tablet (10 mg) plus a placebo amitriptyline capsule will be taken by mouth at night half an hour before bedtime for 12 weeks. Placebo escitalopram tablets and placebo amitriptyline capsules will be taken by mouth half an hour before bedtime for 12 weeks.
All-Cause Mortality
Amitriptyline Escitalopram Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Amitriptyline Escitalopram Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/97 (0.00%)   0/98 (0.00%)   0/97 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Amitriptyline Escitalopram Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   29/97 (29.90%)   28/98 (28.57%)   20/97 (20.62%) 
Blood and lymphatic system disorders       
Bruising   0/97 (0.00%)  0/98 (0.00%)  1/97 (1.03%) 
Cardiac disorders       
Chest pain   0/97 (0.00%)  1/98 (1.02%)  0/97 (0.00%) 
Palpitations   0/97 (0.00%)  0/98 (0.00%)  1/97 (1.03%) 
Vasovagal syncope   0/97 (0.00%)  1/98 (1.02%)  1/97 (1.03%) 
Ear and labyrinth disorders       
Infectious   1/97 (1.03%)  0/98 (0.00%)  0/97 (0.00%) 
Non-infectious   2/97 (2.06%)  2/98 (2.04%)  1/97 (1.03%) 
Endocrine disorders       
Decreased libido   0/97 (0.00%)  3/98 (3.06%)  0/97 (0.00%) 
Enlarged thyroid   0/97 (0.00%)  1/98 (1.02%)  0/97 (0.00%) 
Hot/cold sensitivity   0/97 (0.00%)  1/98 (1.02%)  1/97 (1.03%) 
Ovarian cysts   2/97 (2.06%)  0/98 (0.00%)  0/97 (0.00%) 
Eye disorders       
Infection   0/97 (0.00%)  1/98 (1.02%)  0/97 (0.00%) 
Non-infection   1/97 (1.03%)  0/98 (0.00%)  0/97 (0.00%) 
Vision changes   1/97 (1.03%)  0/98 (0.00%)  1/97 (1.03%) 
Gastrointestinal disorders       
Abdominal Pain   5/97 (5.15%)  5/98 (5.10%)  1/97 (1.03%) 
Black Stools   1/97 (1.03%)  0/98 (0.00%)  0/97 (0.00%) 
Bloating   1/97 (1.03%)  1/98 (1.02%)  1/97 (1.03%) 
C. Difficile Infection   1/97 (1.03%)  0/98 (0.00%)  0/97 (0.00%) 
Change in appetite   0/97 (0.00%)  2/98 (2.04%)  0/97 (0.00%) 
Constipation   5/97 (5.15%)  2/98 (2.04%)  1/97 (1.03%) 
Diarrhea   2/97 (2.06%)  1/98 (1.02%)  1/97 (1.03%) 
Dry mouth   2/97 (2.06%)  0/98 (0.00%)  0/97 (0.00%) 
Heartburn   1/97 (1.03%)  0/98 (0.00%)  1/97 (1.03%) 
Hemorrhoids   0/97 (0.00%)  0/98 (0.00%)  1/97 (1.03%) 
Intestinal fluid   0/97 (0.00%)  0/98 (0.00%)  2/97 (2.06%) 
Nausea/Vomiting   6/97 (6.19%)  9/98 (9.18%)  3/97 (3.09%) 
Hepatobiliary disorders       
Liver function abnormality   1/97 (1.03%)  1/98 (1.02%)  0/97 (0.00%) 
Metabolism and nutrition disorders       
Dehydration   0/97 (0.00%)  0/98 (0.00%)  1/97 (1.03%) 
Edema   0/97 (0.00%)  0/98 (0.00%)  2/97 (2.06%) 
Weight gain   0/97 (0.00%)  1/98 (1.02%)  0/97 (0.00%) 
Musculoskeletal and connective tissue disorders       
Arthralgia   2/97 (2.06%)  0/98 (0.00%)  0/97 (0.00%) 
Back pain   4/97 (4.12%)  5/98 (5.10%)  0/97 (0.00%) 
Pain (other than back and pelvic)   4/97 (4.12%)  2/98 (2.04%)  2/97 (2.06%) 
Pelvic pain   2/97 (2.06%)  0/98 (0.00%)  0/97 (0.00%) 
Nervous system disorders       
Anxiety   2/97 (2.06%)  6/98 (6.12%)  4/97 (4.12%) 
Depression   0/97 (0.00%)  0/98 (0.00%)  1/97 (1.03%) 
Dizziness   5/97 (5.15%)  11/98 (11.22%)  1/97 (1.03%) 
Dream abnormalities   1/97 (1.03%)  0/98 (0.00%)  0/97 (0.00%) 
Drowsiness or Somnolence   14/97 (14.43%)  10/98 (10.20%)  5/97 (5.15%) 
Headache   2/97 (2.06%)  8/98 (8.16%)  3/97 (3.09%) 
Insomnia   2/97 (2.06%)  5/98 (5.10%)  1/97 (1.03%) 
Tingling   1/97 (1.03%)  1/98 (1.02%)  1/97 (1.03%) 
Renal and urinary disorders       
Dysuria   1/97 (1.03%)  0/98 (0.00%)  0/97 (0.00%) 
Prostate infection   1/97 (1.03%)  0/98 (0.00%)  0/97 (0.00%) 
Urinary tract infection   2/97 (2.06%)  0/98 (0.00%)  0/97 (0.00%) 
Reproductive system and breast disorders       
Menstrual disorder   2/97 (2.06%)  0/98 (0.00%)  0/97 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Infectious   6/97 (6.19%)  1/98 (1.02%)  1/97 (1.03%) 
Non-infectious   0/97 (0.00%)  1/98 (1.02%)  0/97 (0.00%) 
Cough   2/97 (2.06%)  1/98 (1.02%)  0/97 (0.00%) 
Dyspnea   0/97 (0.00%)  0/98 (0.00%)  2/97 (2.06%) 
Skin and subcutaneous tissue disorders       
Abrasion   0/97 (0.00%)  0/98 (0.00%)  2/97 (2.06%) 
Infection   0/97 (0.00%)  0/98 (0.00%)  1/97 (1.03%) 
Rash   0/97 (0.00%)  3/98 (3.06%)  5/97 (5.15%) 
Indicates events were collected by systematic assessment
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
Layout table for Results Point of Contact information
Name/Title: Dr. Yuri A. Saito Loftus
Organization: Mayo Clinic
Phone: 507-266-9094
EMail: saito.yuri@mayo.edu
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
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