FDTT: Functional Dyspepsia Treatment Trial
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:
-
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.
-
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
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:
|
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:
|
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
- 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
- Gastric Emptying Half-Time (T1/2) [12 weeks]
The time for half of the ingested solids or liquids to leave the stomach.
- 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.
- 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
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.- 2021-05 (DK065713)
- U01DK065713
- NCT00275626
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
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 |
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)
|
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)
|
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
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 |
saito.yuri@mayo.edu |
- 2021-05 (DK065713)
- U01DK065713
- NCT00275626