Trial · NCT00248651

Functional Dyspepsia Treatment Trial

NCT00248651, Phase 2, Phase 3, Completed, Mayo Clinic; results first posted 2014-07-25

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Functional Dyspepsia Treatment Trial. Trials, record NCT00248651. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00248651

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Functional Dyspepsia Treatment Trial
NCT number: NCT00248651
Status: Completed
Phases: Phase 2, Phase 3
Enrollment: 292 participants, actual
Lead sponsor: Mayo Clinic
Conditions: Dyspepsia and Other Specified Disorders of Function of Stomach
Interventions: Amitriptyline, Escitalopram, Placebo
First posted: 2005-11-04
Last updated: 2014-07-25
Results first posted: 2014-07-25

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Self-Report of Adequate Relief of Dyspepsia (Yes/No) For at Least 50% of Weeks 3 -12 of Treatment	3 weeks through 12 weeks	The first two weeks of treatment were excluded to allow for establishment of steady state drug levels.
Secondary	Gastric Emptying Half-Time (T1/2)	12 weeks	The time for half of the ingested solids or liquids to leave the stomach.
Secondary	Maximum Tolerated Volume by Nutrient Drink Test	12 weeks	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.
Secondary	Dyspepsia-Specific Quality of Life	12 Weeks	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.

Source ClinicalTrials.gov

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Self-Report of Adequate Relief of Dyspepsia (Yes/No) For at Least 50% of Weeks 3 -12 of Treatment	3 weeks through 12 weeks	The intent-to-treat analysis included all randomized subjects.	percentage of participants	NUMBER
SECONDARY	Gastric Emptying Half-Time (T1/2)	12 weeks	The intent-to-treat analysis included all randomized subjects.	minutes	MEAN
SECONDARY	Maximum Tolerated Volume by Nutrient Drink Test	12 weeks	The intent-to-treat analysis included all randomized subjects.	ml	MEAN
SECONDARY	Dyspepsia-Specific Quality of Life	12 Weeks	The intent-to-treat analysis included all randomized subjects.	units on a scale	MEAN

Source ClinicalTrials.gov

Results by group27

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Self-Report of Adequate Relief of Dyspepsia (Yes/No) For at Least 50% of Weeks 3 -12 of Treatment	Amitriptyline		53		percentage of participants
Self-Report of Adequate Relief of Dyspepsia (Yes/No) For at Least 50% of Weeks 3 -12 of Treatment	Escitalopram		38		percentage of participants
Self-Report of Adequate Relief of Dyspepsia (Yes/No) For at Least 50% of Weeks 3 -12 of Treatment	Placebo		40		percentage of participants
Gastric Emptying Half-Time (T1/2)	Amitriptyline		117	Standard Deviation 43	minutes
Gastric Emptying Half-Time (T1/2)	Escitalopram		108	Standard Deviation 36	minutes
Gastric Emptying Half-Time (T1/2)	Placebo		115	Standard Deviation 40	minutes
Maximum Tolerated Volume by Nutrient Drink Test	Amitriptyline		764	Standard Deviation 319	ml
Maximum Tolerated Volume by Nutrient Drink Test	Escitalopram		823	Standard Deviation 391	ml
Maximum Tolerated Volume by Nutrient Drink Test	Placebo		839	Standard Deviation 442	ml
Dyspepsia-Specific Quality of Life	Amitriptyline	Overall Quality of Life	80.6	95% Confidence Interval 76.2 to 85.0	units on a scale

1 to 10 of 27Source ClinicalTrials.gov

See all 27 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Amitriptyline	97
Overall Study	STARTED	Escitalopram	98
Overall Study	STARTED	Placebo	97
Overall Study	Completed 12 Weeks of Treatment	Amitriptyline	78
Overall Study	Completed 12 Weeks of Treatment	Escitalopram	66
Overall Study	Completed 12 Weeks of Treatment	Placebo	75
Overall Study	COMPLETED	Amitriptyline	69
Overall Study	COMPLETED	Escitalopram	58
Overall Study	COMPLETED	Placebo	65
Overall Study	NOT COMPLETED	Amitriptyline	28

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events156

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Abdominal Pain	Gastrointestinal disorders	Amitriptyline	5	97
other	Abdominal Pain	Gastrointestinal disorders	Escitalopram	5	98
other	Abdominal Pain	Gastrointestinal disorders	Placebo	1	97
other	Black Stools	Gastrointestinal disorders	Amitriptyline	1	97
other	Black Stools	Gastrointestinal disorders	Escitalopram	0	98
other	Black Stools	Gastrointestinal disorders	Placebo	0	97
other	Bloating	Gastrointestinal disorders	Amitriptyline	1	97
other	Bloating	Gastrointestinal disorders	Escitalopram	1	98
other	Bloating	Gastrointestinal disorders	Placebo	1	97
other	C. Difficile Infection	Gastrointestinal disorders	Amitriptyline	1	97

1 to 10 of 156Source ClinicalTrials.gov

See all 156 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Amitriptyline
Total, all-cause mortality	Escitalopram
Total, all-cause mortality	Placebo
Total, other adverse events	Amitriptyline	29	97
Total, other adverse events	Escitalopram	28	98
Total, other adverse events	Placebo	20	97
Total, serious adverse events	Amitriptyline	0	97
Total, serious adverse events	Escitalopram	0	98
Total, serious adverse events	Placebo	0	97

Source ClinicalTrials.gov

Papers4

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
22343090	DERIVED	PubMed
25761431	DERIVED	PubMed
25921377	DERIVED	PubMed
29199141	DERIVED	PubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
U01DK065713	Antidepressant Therapy for Functional Dyspepsia	SAITO LOFTUS, YURI ANN	MAYO CLINIC ROCHESTER	NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES	2005 to 2011

Source NIH RePORTER

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

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