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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

Tracking Information
First Submitted Date  ICMJE November 3, 2005
First Posted Date  ICMJE November 4, 2005
Results First Submitted Date  ICMJE June 26, 2014
Results First Posted Date  ICMJE July 25, 2014
Last Update Posted Date July 25, 2014
Study Start Date  ICMJE October 2006
Actual Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 26, 2014)
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 ]
The first two weeks of treatment were excluded to allow for establishment of steady state drug levels.
Original Primary Outcome Measures  ICMJE
 (submitted: November 3, 2005)
1.Assess whether antidepressant therapy is more efficacious than placebo in relief of the symptoms of functional dyspepsia, adjusting for psychological and psychiatric co-morbidity.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 26, 2014)
  • Gastric Emptying Half-Time (T1/2) [ Time Frame: 12 weeks ]
    The time for half of the ingested solids or liquids to leave the stomach.
  • Maximum Tolerated Volume by Nutrient Drink Test [ Time Frame: 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.
  • Dyspepsia-Specific Quality of Life [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 3, 2005)
  • 2. . Assess whether gastric emptying and the nutrient drink test is altered by therapy with a tricyclic or SSRI antidepressant.
  • 3.Examine whether polymorphisms of the heterotrimeric G protein and serotonin reuptake transporter predict outcome in functional dyspepsia patients receiving antidepressant therapy.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Functional Dyspepsia Treatment Trial
Official Title  ICMJE Antidepressant Therapy for Functional Dyspepsia
Brief Summary

Functional dyspepsia is a common gastrointestinal disorder. Symptoms can include stomach pain or discomfort, bloating, fullness after eating meals, and nausea. These symptoms often interfere with school and work, and weight loss may occur due to dietary restrictions.

The hypothesis of this study was that antidepressant therapy is more effective than placebo in relief of the symptoms of functional dyspepsia, adjusting for psychological and psychiatric co-morbidity. The study also examined if antidepressant therapy reduces disability and improves quality of life in functional dyspepsia.

Detailed Description

The aims of this study were to:

  1. Determine whether antidepressant therapy is more efficacious than placebo in relief of the symptoms of functional dyspepsia, adjusting for psychological and psychiatric co-morbidity. The investigators also planned to determine if antidepressant therapy reduces disability, improves quality of life and influences clinical response over 6 months after ceasing medication.
  2. Determine if gastric emptying (motor dysfunction) and the nutrient drink test (a test that assesses gastric hypersensitivity and/or gastric accommodation) is altered by antidepressant therapy with a tricyclic or selective serotonin re-uptake inhibitors (SSRI), and whether subgroups with altered physiology are associated with treatment outcome.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Dyspepsia and Other Specified Disorders of Function of Stomach
Intervention  ICMJE
  • Drug: Amitriptyline
    25 mg capsule by mouth at bedtime for two weeks, then 50 mg capsule by mouth at bedtime for 10 weeks. The drug will be provided in blister packs.
    Other Name: Elavil
  • Drug: Escitalopram
    10 mg tablets by mouth at bedtime for 12 weeks. The drug will be provided in blister packs.
    Other Name: Lexapro
  • Drug: Placebo
    Placebo escitalopram and placebo amitriptyline will be manufactured to ensure all tablets and capsules will be indistinguishable, and provided in blister packs.
Study Arms  ICMJE
  • Active Comparator: 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.
    Intervention: Drug: Amitriptyline
  • Active Comparator: 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.
    Intervention: Drug: Escitalopram
  • Placebo Comparator: Placebo
    Placebo escitalopram tablets and placebo amitriptyline capsules will be taken by mouth half an hour before bedtime for 12 weeks.
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 26, 2014)
292
Original Enrollment  ICMJE
 (submitted: November 3, 2005)
400
Actual Study Completion Date  ICMJE July 2013
Actual Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Normal esophagogastroduodenoscopy (EGD) (no esophagitis, Barrett's esophagus, cancer, erosions, or ulcer disease) within the past 5 years
  • Diagnosis of functional dyspepsia
  • Patients may have failed to adequately respond to antisecretory therapy in the past for functional dyspepsia to be suitable; a good response to antisecretory therapy, which remains first line therapy, suggests underlying gastroesophageal reflux disease (GERD).

Exclusion Criteria:

  • Any documented history of endoscopic esophagitis, or predominant heartburn or acid regurgitation, or these symptoms two or more times per week in the prior year, to exclude GERD.
  • Those who have had an adequate response to antisecretory therapy according to the physician interview, to exclude patients with disease easy to control with first line therapy or misdiagnosed GERD.
  • Any documented peptic ulcer disease.
  • Regular use of non-steroidal anti-inflammatory drugs (except long term low dose aspirin ≤ 325 mg / day)
  • Subjects undergoing psychiatric treatment, having a current history of drug or alcohol abuse, or currently taking psychotropic medication for depression or psychosis, or eating disorders
  • A history of abdominal surgery except appendectomy, cholecystectomy or hysterectomy, tubal ligations, bladder slings, and vasectomies
  • Subjects with concurrent major physical illness (including cardiac or liver disease, diabetes, inflammatory bowel disease, glaucoma, urinary retention, active thyroid disease, vasculitis, lactose intolerance explaining symptoms)
  • Subjects whose literacy skills are insufficient to complete self report questionnaires.
  • Pregnancy, or refusal to apply adequate contraceptive measures during the trial
  • Subjects currently on antidepressant therapy will be excluded.
  • Patients who score 11 or greater on the 7 questions related to depression of the Hospital Anxiety Depression Scale will be excluded. These patients will be encouraged to get follow up for depression.
  • All eligible patients over age 50 will have an EKG before randomization. Those found to have significant arrhythmias, conduction defects or a previous myocardial infarction on EKG will be excluded. Anyone with QT prolongation will be excluded.

The following concomitant medications will be prohibited during the trial:

  • Systemically acting cholinergics and anticholinergics (atropine, didinium bromide, propantheline)
  • Prokinetics (e.g., metoclopramide, tegaserod)
  • Macrolide antibiotics (e.g., erythromycin, azithromycin)
  • Aspirin (> 325 mg/day)
  • Spasmolytics (e.g., dicyclomine)
  • Antidepressants other than study medications
  • Serotonin enhancing drugs: monamine oxidase inhibitors, anticonvulsants, dextromethorphan.

Participants will be instructed to avoid grapefruit/grapefruit juice during the trial.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00248651
Other Study ID Numbers  ICMJE 2021-05 (DK065713)
U01DK065713 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Yuri A. Saito Loftus, Mayo Clinic
Study Sponsor  ICMJE Mayo Clinic
Collaborators  ICMJE National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators  ICMJE
Principal Investigator: Earnest P Bouras, M.D. Mayo Clinic
Principal Investigator: John K. DiBaise, M.D. Mayo Clinic
Principal Investigator: Colin P Howden, M.D. Northwestern University Chicago
Principal Investigator: Charlene M Prather, M.D. St. Louis University
Study Chair: Nicholas J Talley, M.D.,Ph.D. Mayo Clinic
Principal Investigator: Brian E. Lacy, M.D., Ph.D. Dartmouth-Hitchcock Medical Center
Principal Investigator: G. R. Locke, III, M.D. Mayo Clinic
Principal Investigator: Bincy P Abraham, M.D., M.S. Baylor College of Medicine
Principal Investigator: Hashem El-Serag, M.D. Baylor College of Medicine
Principal Investigator: Paul Moayyedi, M.D. McMaster University Centre, Hamilton, Ontario
PRS Account Mayo Clinic
Verification Date June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP