FDTT: Functional Dyspepsia Treatment Trial

Sponsor
Mayo Clinic (Other)
Overall Status
Completed
CT.gov ID
NCT00248651
Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)
292
8
3
81
36.5
0.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2/Phase 3

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 Design

Study Type:
Interventional
Actual Enrollment :
292 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
Antidepressant Therapy for Functional Dyspepsia
Study Start Date :
Oct 1, 2006
Actual Primary Completion Date :
Jul 1, 2013
Actual Study Completion Date :
Jul 1, 2013

Arms and Interventions

Arm Intervention/Treatment
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.

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 Names:
  • Elavil
  • 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.

    Drug: Escitalopram
    10 mg tablets by mouth at bedtime for 12 weeks. The drug will be provided in blister packs.
    Other Names:
  • Lexapro
  • Placebo Comparator: Placebo

    Placebo escitalopram tablets and placebo amitriptyline capsules will be taken by mouth half an hour before bedtime for 12 weeks.

    Drug: Placebo
    Placebo escitalopram and placebo amitriptyline will be manufactured to ensure all tablets and capsules will be indistinguishable, and provided in blister packs.

    Outcome Measures

    Primary Outcome Measures

    1. 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 Outcome Measures

    1. Gastric Emptying Half-Time (T1/2) [12 weeks]

      The time for half of the ingested solids or liquids to leave the stomach.

    2. 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.

    3. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mayo Clinic Scottsdale Arizona United States 85259
    2 Mayo Clinic Jacksonville Jacksonville Florida United States 32224
    3 Northwestern University Chicago Chicago Illinois United States 60611
    4 Mayo Clinic Rochester Minnesota United States 55905
    5 Saint Louis University School of Medicine Saint Louis Missouri United States 63130
    6 Dartmouth-Hitchcock Medical Center Lebanon New Hampshire United States 03756
    7 Baylor College of Medicine Houston Texas United States 77030
    8 McMaster University Centre Hamilton Ontario Canada

    Sponsors and Collaborators

    • Mayo Clinic
    • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    Investigators

    • 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yuri A. Saito Loftus, Principal Investigator, Mayo Clinic
    ClinicalTrials.gov Identifier:
    NCT00248651
    Other Study ID Numbers:
    • 2021-05 (DK065713)
    • U01DK065713
    • NCT00275626
    First Posted:
    Nov 4, 2005
    Last Update Posted:
    Jul 25, 2014
    Last Verified:
    Jun 1, 2014
    Keywords provided by Yuri A. Saito Loftus, Principal Investigator, Mayo Clinic
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details Study enrollment was during October 27, 2006 to February 11, 2013.
    Pre-assignment Detail
    Arm/Group Title Amitriptyline Escitalopram Placebo
    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

    Baseline Characteristics

    Arm/Group Title Amitriptyline Escitalopram Placebo Total
    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 Participants 97 98 97 292
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    43
    (15)
    45
    (15)
    45
    (16)
    44
    (15)
    Sex: Female, Male (Count of Participants)
    Female
    74
    76.3%
    72
    73.5%
    73
    75.3%
    219
    75%
    Male
    23
    23.7%
    26
    26.5%
    24
    24.7%
    73
    25%
    Region of Enrollment (participants) [Number]
    United States
    94
    96.9%
    94
    95.9%
    96
    99%
    284
    97.3%
    Canada
    3
    3.1%
    4
    4.1%
    1
    1%
    8
    2.7%

    Outcome Measures

    1. Primary Outcome
    Title Self-Report of Adequate Relief of Dyspepsia (Yes/No) For at Least 50% of Weeks 3 -12 of Treatment
    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

    Outcome Measure Data

    Analysis Population Description
    The intent-to-treat analysis included all randomized subjects.
    Arm/Group Title Amitriptyline Escitalopram Placebo
    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.
    Measure Participants 97 98 97
    Number [percentage of participants]
    53
    54.6%
    38
    38.8%
    40
    41.2%
    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
    Statistical Test of Hypothesis p-Value 0.05
    Comments
    Method ANCOVA
    Comments
    2. Secondary Outcome
    Title Gastric Emptying Half-Time (T1/2)
    Description The time for half of the ingested solids or liquids to leave the stomach.
    Time Frame 12 weeks

    Outcome Measure Data

    Analysis Population Description
    The intent-to-treat analysis included all randomized subjects.
    Arm/Group Title Amitriptyline Escitalopram Placebo
    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.
    Measure Participants 97 98 97
    Mean (Standard Deviation) [minutes]
    117
    (43)
    108
    (36)
    115
    (40)
    3. Secondary Outcome
    Title Maximum Tolerated Volume by Nutrient Drink Test
    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

    Outcome Measure Data

    Analysis Population Description
    The intent-to-treat analysis included all randomized subjects.
    Arm/Group Title Amitriptyline Escitalopram Placebo
    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.
    Measure Participants 97 98 97
    Mean (Standard Deviation) [ml]
    764
    (319)
    823
    (391)
    839
    (442)
    4. Secondary Outcome
    Title Dyspepsia-Specific Quality of Life
    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

    Outcome Measure Data

    Analysis Population Description
    The intent-to-treat analysis included all randomized subjects.
    Arm/Group Title Amitriptyline Escitalopram Placebo
    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.
    Measure Participants 97 98 97
    Overall Quality of Life
    80.6
    82.8
    73.5
    Interference Subscale
    83.2
    82.8
    76.2
    Knowledge/Control Subscale
    78.2
    76.2
    72.9
    Eat/Drink Subscale
    72.4
    70.6
    64.8
    Sleep Disturbance Subscale
    86.3
    80.8
    76.4
    Work/Study Subscale
    86.9
    87.2
    79.7
    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
    Statistical Test of Hypothesis p-Value 0.02
    Comments
    Method ANCOVA
    Comments
    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
    Statistical Test of Hypothesis p-Value 0.06
    Comments
    Method ANCOVA
    Comments
    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
    Statistical Test of Hypothesis p-Value 0.06
    Comments
    Method ANCOVA
    Comments
    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
    Statistical Test of Hypothesis p-Value 0.01
    Comments
    Method ANCOVA
    Comments
    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
    Statistical Test of Hypothesis p-Value 0.04
    Comments
    Method ANCOVA
    Comments

    Adverse Events

    Time Frame
    Adverse Event Reporting Description
    Arm/Group Title Amitriptyline Escitalopram Placebo
    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 (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN) / (NaN)
    Serious Adverse Events
    Amitriptyline Escitalopram Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/97 (0%) 0/98 (0%) 0/97 (0%)
    Other (Not Including Serious) Adverse Events
    Amitriptyline Escitalopram Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 29/97 (29.9%) 28/98 (28.6%) 20/97 (20.6%)
    Blood and lymphatic system disorders
    Bruising 0/97 (0%) 0/98 (0%) 1/97 (1%)
    Cardiac disorders
    Chest pain 0/97 (0%) 1/98 (1%) 0/97 (0%)
    Palpitations 0/97 (0%) 0/98 (0%) 1/97 (1%)
    Vasovagal syncope 0/97 (0%) 1/98 (1%) 1/97 (1%)
    Ear and labyrinth disorders
    Infectious 1/97 (1%) 0/98 (0%) 0/97 (0%)
    Non-infectious 2/97 (2.1%) 2/98 (2%) 1/97 (1%)
    Endocrine disorders
    Decreased libido 0/97 (0%) 3/98 (3.1%) 0/97 (0%)
    Enlarged thyroid 0/97 (0%) 1/98 (1%) 0/97 (0%)
    Hot/cold sensitivity 0/97 (0%) 1/98 (1%) 1/97 (1%)
    Ovarian cysts 2/97 (2.1%) 0/98 (0%) 0/97 (0%)
    Eye disorders
    Infection 0/97 (0%) 1/98 (1%) 0/97 (0%)
    Non-infection 1/97 (1%) 0/98 (0%) 0/97 (0%)
    Vision changes 1/97 (1%) 0/98 (0%) 1/97 (1%)
    Gastrointestinal disorders
    Abdominal Pain 5/97 (5.2%) 5/98 (5.1%) 1/97 (1%)
    Black Stools 1/97 (1%) 0/98 (0%) 0/97 (0%)
    Bloating 1/97 (1%) 1/98 (1%) 1/97 (1%)
    C. Difficile Infection 1/97 (1%) 0/98 (0%) 0/97 (0%)
    Change in appetite 0/97 (0%) 2/98 (2%) 0/97 (0%)
    Constipation 5/97 (5.2%) 2/98 (2%) 1/97 (1%)
    Diarrhea 2/97 (2.1%) 1/98 (1%) 1/97 (1%)
    Dry mouth 2/97 (2.1%) 0/98 (0%) 0/97 (0%)
    Heartburn 1/97 (1%) 0/98 (0%) 1/97 (1%)
    Hemorrhoids 0/97 (0%) 0/98 (0%) 1/97 (1%)
    Intestinal fluid 0/97 (0%) 0/98 (0%) 2/97 (2.1%)
    Nausea/Vomiting 6/97 (6.2%) 9/98 (9.2%) 3/97 (3.1%)
    Hepatobiliary disorders
    Liver function abnormality 1/97 (1%) 1/98 (1%) 0/97 (0%)
    Metabolism and nutrition disorders
    Dehydration 0/97 (0%) 0/98 (0%) 1/97 (1%)
    Edema 0/97 (0%) 0/98 (0%) 2/97 (2.1%)
    Weight gain 0/97 (0%) 1/98 (1%) 0/97 (0%)
    Musculoskeletal and connective tissue disorders
    Arthralgia 2/97 (2.1%) 0/98 (0%) 0/97 (0%)
    Back pain 4/97 (4.1%) 5/98 (5.1%) 0/97 (0%)
    Pain (other than back and pelvic) 4/97 (4.1%) 2/98 (2%) 2/97 (2.1%)
    Pelvic pain 2/97 (2.1%) 0/98 (0%) 0/97 (0%)
    Nervous system disorders
    Anxiety 2/97 (2.1%) 6/98 (6.1%) 4/97 (4.1%)
    Depression 0/97 (0%) 0/98 (0%) 1/97 (1%)
    Dizziness 5/97 (5.2%) 11/98 (11.2%) 1/97 (1%)
    Dream abnormalities 1/97 (1%) 0/98 (0%) 0/97 (0%)
    Drowsiness or Somnolence 14/97 (14.4%) 10/98 (10.2%) 5/97 (5.2%)
    Headache 2/97 (2.1%) 8/98 (8.2%) 3/97 (3.1%)
    Insomnia 2/97 (2.1%) 5/98 (5.1%) 1/97 (1%)
    Tingling 1/97 (1%) 1/98 (1%) 1/97 (1%)
    Renal and urinary disorders
    Dysuria 1/97 (1%) 0/98 (0%) 0/97 (0%)
    Prostate infection 1/97 (1%) 0/98 (0%) 0/97 (0%)
    Urinary tract infection 2/97 (2.1%) 0/98 (0%) 0/97 (0%)
    Reproductive system and breast disorders
    Menstrual disorder 2/97 (2.1%) 0/98 (0%) 0/97 (0%)
    Respiratory, thoracic and mediastinal disorders
    Infectious 6/97 (6.2%) 1/98 (1%) 1/97 (1%)
    Non-infectious 0/97 (0%) 1/98 (1%) 0/97 (0%)
    Cough 2/97 (2.1%) 1/98 (1%) 0/97 (0%)
    Dyspnea 0/97 (0%) 0/98 (0%) 2/97 (2.1%)
    Skin and subcutaneous tissue disorders
    Abrasion 0/97 (0%) 0/98 (0%) 2/97 (2.1%)
    Infection 0/97 (0%) 0/98 (0%) 1/97 (1%)
    Rash 0/97 (0%) 3/98 (3.1%) 5/97 (5.2%)

    Limitations/Caveats

    [Not Specified]

    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
    Email saito.yuri@mayo.edu
    Responsible Party:
    Yuri A. Saito Loftus, Principal Investigator, Mayo Clinic
    ClinicalTrials.gov Identifier:
    NCT00248651
    Other Study ID Numbers:
    • 2021-05 (DK065713)
    • U01DK065713
    • NCT00275626
    First Posted:
    Nov 4, 2005
    Last Update Posted:
    Jul 25, 2014
    Last Verified:
    Jun 1, 2014