Trial Outcomes & Findings for Functional Dyspepsia Treatment Trial (NCT NCT00248651)
NCT ID: NCT00248651
Last Updated: 2014-07-25
Results Overview
The first two weeks of treatment were excluded to allow for establishment of steady state drug levels.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
292 participants
Primary outcome timeframe
3 weeks through 12 weeks
Results posted on
2014-07-25
Participant Flow
Study enrollment was during October 27, 2006 to February 11, 2013.
Participant milestones
| Measure |
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
97
|
98
|
97
|
|
Overall Study
Completed 12 Weeks of Treatment
|
78
|
66
|
75
|
|
Overall Study
COMPLETED
|
69
|
58
|
65
|
|
Overall Study
NOT COMPLETED
|
28
|
40
|
32
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
28
|
40
|
32
|
Baseline Characteristics
Functional Dyspepsia Treatment Trial
Baseline characteristics by cohort
| Measure |
Amitriptyline
n=97 Participants
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
n=98 Participants
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
n=97 Participants
Placebo escitalopram tablets and placebo amitriptyline capsules will be taken by mouth half an hour before bedtime for 12 weeks.
|
Total
n=292 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
43 years
STANDARD_DEVIATION 15 • n=5 Participants
|
45 years
STANDARD_DEVIATION 15 • n=7 Participants
|
45 years
STANDARD_DEVIATION 16 • n=5 Participants
|
44 years
STANDARD_DEVIATION 15 • n=4 Participants
|
|
Sex: Female, Male
Female
|
74 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
219 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
73 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
94 participants
n=5 Participants
|
94 participants
n=7 Participants
|
96 participants
n=5 Participants
|
284 participants
n=4 Participants
|
|
Region of Enrollment
Canada
|
3 participants
n=5 Participants
|
4 participants
n=7 Participants
|
1 participants
n=5 Participants
|
8 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 3 weeks through 12 weeksPopulation: The intent-to-treat analysis included all randomized subjects.
The first two weeks of treatment were excluded to allow for establishment of steady state drug levels.
Outcome measures
| Measure |
Amitriptyline
n=97 Participants
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
n=98 Participants
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
n=97 Participants
Placebo escitalopram tablets and placebo amitriptyline capsules will be taken by mouth half an hour before bedtime for 12 weeks.
|
|---|---|---|---|
|
Self-Report of Adequate Relief of Dyspepsia (Yes/No) For at Least 50% of Weeks 3 -12 of Treatment
|
53 percentage of participants
|
38 percentage of participants
|
40 percentage of participants
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: The intent-to-treat analysis included all randomized subjects.
The time for half of the ingested solids or liquids to leave the stomach.
Outcome measures
| Measure |
Amitriptyline
n=97 Participants
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
n=98 Participants
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
n=97 Participants
Placebo escitalopram tablets and placebo amitriptyline capsules will be taken by mouth half an hour before bedtime for 12 weeks.
|
|---|---|---|---|
|
Gastric Emptying Half-Time (T1/2)
|
117 minutes
Standard Deviation 43
|
108 minutes
Standard Deviation 36
|
115 minutes
Standard Deviation 40
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: The intent-to-treat analysis included all randomized subjects.
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.
Outcome measures
| Measure |
Amitriptyline
n=97 Participants
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
n=98 Participants
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
n=97 Participants
Placebo escitalopram tablets and placebo amitriptyline capsules will be taken by mouth half an hour before bedtime for 12 weeks.
|
|---|---|---|---|
|
Maximum Tolerated Volume by Nutrient Drink Test
|
764 ml
Standard Deviation 319
|
823 ml
Standard Deviation 391
|
839 ml
Standard Deviation 442
|
SECONDARY outcome
Timeframe: 12 WeeksPopulation: The intent-to-treat analysis included all randomized subjects.
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.
Outcome measures
| Measure |
Amitriptyline
n=97 Participants
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
n=98 Participants
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
n=97 Participants
Placebo escitalopram tablets and placebo amitriptyline capsules will be taken by mouth half an hour before bedtime for 12 weeks.
|
|---|---|---|---|
|
Dyspepsia-Specific Quality of Life
Overall Quality of Life
|
80.6 units on a scale
Interval 76.2 to 85.0
|
82.8 units on a scale
Interval 78.4 to 87.1
|
73.5 units on a scale
Interval 69.1 to 77.8
|
|
Dyspepsia-Specific Quality of Life
Interference Subscale
|
83.2 units on a scale
Interval 78.3 to 88.2
|
82.8 units on a scale
Interval 78.4 to 87.1
|
76.2 units on a scale
Interval 70.9 to 81.5
|
|
Dyspepsia-Specific Quality of Life
Knowledge/Control Subscale
|
78.2 units on a scale
Interval 73.2 to 83.2
|
76.2 units on a scale
Interval 71.3 to 81.1
|
72.9 units on a scale
Interval 68.2 to 77.6
|
|
Dyspepsia-Specific Quality of Life
Eat/Drink Subscale
|
72.4 units on a scale
Interval 66.7 to 78.0
|
70.6 units on a scale
Interval 65.4 to 75.6
|
64.8 units on a scale
Interval 59.6 to 70.1
|
|
Dyspepsia-Specific Quality of Life
Sleep Disturbance Subscale
|
86.3 units on a scale
Interval 81.6 to 91.0
|
80.8 units on a scale
Interval 75.2 to 86.3
|
76.4 units on a scale
Interval 70.9 to 81.8
|
|
Dyspepsia-Specific Quality of Life
Work/Study Subscale
|
86.9 units on a scale
Interval 82.6 to 91.1
|
87.2 units on a scale
Interval 83.5 to 90.9
|
79.7 units on a scale
Interval 74.5 to 84.9
|
Adverse Events
Amitriptyline
Serious events: 0 serious events
Other events: 29 other events
Deaths: 0 deaths
Escitalopram
Serious events: 0 serious events
Other events: 28 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Amitriptyline
n=97 participants at risk
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
n=98 participants at risk
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
n=97 participants at risk
Placebo escitalopram tablets and placebo amitriptyline capsules will be taken by mouth half an hour before bedtime for 12 weeks.
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
5.2%
5/97
|
5.1%
5/98
|
1.0%
1/97
|
|
Gastrointestinal disorders
Black Stools
|
1.0%
1/97
|
0.00%
0/98
|
0.00%
0/97
|
|
Gastrointestinal disorders
Bloating
|
1.0%
1/97
|
1.0%
1/98
|
1.0%
1/97
|
|
Gastrointestinal disorders
C. Difficile Infection
|
1.0%
1/97
|
0.00%
0/98
|
0.00%
0/97
|
|
Gastrointestinal disorders
Change in appetite
|
0.00%
0/97
|
2.0%
2/98
|
0.00%
0/97
|
|
Gastrointestinal disorders
Constipation
|
5.2%
5/97
|
2.0%
2/98
|
1.0%
1/97
|
|
Gastrointestinal disorders
Diarrhea
|
2.1%
2/97
|
1.0%
1/98
|
1.0%
1/97
|
|
Gastrointestinal disorders
Dry mouth
|
2.1%
2/97
|
0.00%
0/98
|
0.00%
0/97
|
|
Gastrointestinal disorders
Heartburn
|
1.0%
1/97
|
0.00%
0/98
|
1.0%
1/97
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/97
|
0.00%
0/98
|
1.0%
1/97
|
|
Gastrointestinal disorders
Intestinal fluid
|
0.00%
0/97
|
0.00%
0/98
|
2.1%
2/97
|
|
Hepatobiliary disorders
Liver function abnormality
|
1.0%
1/97
|
1.0%
1/98
|
0.00%
0/97
|
|
Gastrointestinal disorders
Nausea/Vomiting
|
6.2%
6/97
|
9.2%
9/98
|
3.1%
3/97
|
|
Nervous system disorders
Anxiety
|
2.1%
2/97
|
6.1%
6/98
|
4.1%
4/97
|
|
Nervous system disorders
Depression
|
0.00%
0/97
|
0.00%
0/98
|
1.0%
1/97
|
|
Nervous system disorders
Dizziness
|
5.2%
5/97
|
11.2%
11/98
|
1.0%
1/97
|
|
Nervous system disorders
Dream abnormalities
|
1.0%
1/97
|
0.00%
0/98
|
0.00%
0/97
|
|
Nervous system disorders
Drowsiness or Somnolence
|
14.4%
14/97
|
10.2%
10/98
|
5.2%
5/97
|
|
Nervous system disorders
Headache
|
2.1%
2/97
|
8.2%
8/98
|
3.1%
3/97
|
|
Nervous system disorders
Insomnia
|
2.1%
2/97
|
5.1%
5/98
|
1.0%
1/97
|
|
Nervous system disorders
Tingling
|
1.0%
1/97
|
1.0%
1/98
|
1.0%
1/97
|
|
Cardiac disorders
Chest pain
|
0.00%
0/97
|
1.0%
1/98
|
0.00%
0/97
|
|
Cardiac disorders
Palpitations
|
0.00%
0/97
|
0.00%
0/98
|
1.0%
1/97
|
|
Cardiac disorders
Vasovagal syncope
|
0.00%
0/97
|
1.0%
1/98
|
1.0%
1/97
|
|
Skin and subcutaneous tissue disorders
Abrasion
|
0.00%
0/97
|
0.00%
0/98
|
2.1%
2/97
|
|
Skin and subcutaneous tissue disorders
Infection
|
0.00%
0/97
|
0.00%
0/98
|
1.0%
1/97
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/97
|
3.1%
3/98
|
5.2%
5/97
|
|
Endocrine disorders
Decreased libido
|
0.00%
0/97
|
3.1%
3/98
|
0.00%
0/97
|
|
Endocrine disorders
Enlarged thyroid
|
0.00%
0/97
|
1.0%
1/98
|
0.00%
0/97
|
|
Endocrine disorders
Hot/cold sensitivity
|
0.00%
0/97
|
1.0%
1/98
|
1.0%
1/97
|
|
Endocrine disorders
Ovarian cysts
|
2.1%
2/97
|
0.00%
0/98
|
0.00%
0/97
|
|
Blood and lymphatic system disorders
Bruising
|
0.00%
0/97
|
0.00%
0/98
|
1.0%
1/97
|
|
Reproductive system and breast disorders
Menstrual disorder
|
2.1%
2/97
|
0.00%
0/98
|
0.00%
0/97
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/97
|
0.00%
0/98
|
1.0%
1/97
|
|
Metabolism and nutrition disorders
Edema
|
0.00%
0/97
|
0.00%
0/98
|
2.1%
2/97
|
|
Metabolism and nutrition disorders
Weight gain
|
0.00%
0/97
|
1.0%
1/98
|
0.00%
0/97
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.1%
2/97
|
0.00%
0/98
|
0.00%
0/97
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.1%
4/97
|
5.1%
5/98
|
0.00%
0/97
|
|
Musculoskeletal and connective tissue disorders
Pain (other than back and pelvic)
|
4.1%
4/97
|
2.0%
2/98
|
2.1%
2/97
|
|
Musculoskeletal and connective tissue disorders
Pelvic pain
|
2.1%
2/97
|
0.00%
0/98
|
0.00%
0/97
|
|
Ear and labyrinth disorders
Infectious
|
1.0%
1/97
|
0.00%
0/98
|
0.00%
0/97
|
|
Ear and labyrinth disorders
Non-infectious
|
2.1%
2/97
|
2.0%
2/98
|
1.0%
1/97
|
|
Respiratory, thoracic and mediastinal disorders
Infectious
|
6.2%
6/97
|
1.0%
1/98
|
1.0%
1/97
|
|
Respiratory, thoracic and mediastinal disorders
Non-infectious
|
0.00%
0/97
|
1.0%
1/98
|
0.00%
0/97
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.1%
2/97
|
1.0%
1/98
|
0.00%
0/97
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/97
|
0.00%
0/98
|
2.1%
2/97
|
|
Eye disorders
Infection
|
0.00%
0/97
|
1.0%
1/98
|
0.00%
0/97
|
|
Eye disorders
Non-infection
|
1.0%
1/97
|
0.00%
0/98
|
0.00%
0/97
|
|
Eye disorders
Vision changes
|
1.0%
1/97
|
0.00%
0/98
|
1.0%
1/97
|
|
Renal and urinary disorders
Dysuria
|
1.0%
1/97
|
0.00%
0/98
|
0.00%
0/97
|
|
Renal and urinary disorders
Prostate infection
|
1.0%
1/97
|
0.00%
0/98
|
0.00%
0/97
|
|
Renal and urinary disorders
Urinary tract infection
|
2.1%
2/97
|
0.00%
0/98
|
0.00%
0/97
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place