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A Randomized Trial of Medical and Surgical Treatments for Patients With GERD Symptoms That Are Refractory to Proton Pump Inhibitors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01265550
Recruitment Status : Completed
First Posted : December 23, 2010
Results First Posted : February 26, 2018
Last Update Posted : January 22, 2020
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition GERD
Interventions Device: Nissen fundoplication
Drug: baclofen
Drug: Desipramine
Enrollment 366
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Medical Treatment Group Surgical Treatment Group Placebo Medical Treatment Group All Enrolled
Hide Arm/Group Description

baclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals.

The dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved.

Desipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit.

Nissen fundoplication: laparoscopic antireflux surgery

baclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals.

The dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved.

Desipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit.

All patients consented.
Period Title: Pre Randomization
Started 0 0 0 366
Completed 0 0 0 78
Not Completed 0 0 0 288
Reason Not Completed
Withdrawal by Subject             0             0             0             70
Technical Exclusions             0             0             0             54
GERD, PPI-Responsive             0             0             0             42
Non-GERD organic disorders             0             0             0             23
Functional heartburn             0             0             0             99
Period Title: Post Randomization
Started 25 27 26 0
Completed 10 19 6 0
Not Completed 15 8 20 0
Arm/Group Title Medical Treatment Group Surgical Treatment Group Placebo Medical Treatment Group Not Randomized Total
Hide Arm/Group Description

baclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals.

The dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved.

Desipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit.

Nissen fundoplication: laparoscopic antireflux surgery

baclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals.

The dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved.

Desipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit.

Subset of all enrolled participants who did not end up being randomized to the study. Total of all reporting groups
Overall Number of Baseline Participants 25 27 26 288 366
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 25 participants 27 participants 26 participants 280 participants 358 participants
43.9  (12.2) 44.9  (11.8) 47.2  (11.7) 49.3  (12.2) 45.4  (11.8)
[1]
Measure Analysis Population Description: Missing data
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 27 participants 26 participants 279 participants 357 participants
Female
7
  28.0%
4
  14.8%
3
  11.5%
63
  22.6%
77
  21.6%
Male
18
  72.0%
23
  85.2%
23
  88.5%
216
  77.4%
280
  78.4%
[1]
Measure Analysis Population Description: Missing data.
Ethnicity (NIH/OMB)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 27 participants 26 participants 279 participants 357 participants
Hispanic or Latino
4
  16.0%
7
  25.9%
2
   7.7%
40
  14.3%
53
  14.8%
Not Hispanic or Latino
21
  84.0%
20
  74.1%
23
  88.5%
230
  82.4%
294
  82.4%
Unknown or Not Reported
0
   0.0%
0
   0.0%
1
   3.8%
9
   3.2%
10
   2.8%
[1]
Measure Analysis Population Description: Missing data.
Race (NIH/OMB)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 27 participants 26 participants 279 participants 357 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
3
   1.1%
3
   0.8%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
2
   0.7%
2
   0.6%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
1
   3.8%
0
   0.0%
1
   0.3%
Black or African American
2
   8.0%
2
   7.4%
5
  19.2%
54
  19.4%
63
  17.6%
White
20
  80.0%
17
  63.0%
17
  65.4%
183
  65.6%
237
  66.4%
More than one race
2
   8.0%
2
   7.4%
2
   7.7%
16
   5.7%
22
   6.2%
Unknown or Not Reported
1
   4.0%
6
  22.2%
1
   3.8%
21
   7.5%
29
   8.1%
[1]
Measure Analysis Population Description: Missing data
1.Primary Outcome
Title Number of Participants Achieving at Least a 50% Improvement in the Gastroesophageal Reflux Disease Health-related Quality of Life Index (GERD-HRQL) From Baseline to 12 Months
Hide Description

Success; ≥50% improvement in the baseline GERD-HRQL score at 12 months.

Failure; <50% improvement in the baseline GERD-HRQL score at 12 months or:

  1. For patients randomized to Surgical Treatment: a.<50% improvement in the baseline GERD-HRQL score and/or persistent heartburn of sufficient severity to warrant treatment with any antisecretory medication, antireflux medication or neurotropic medication at any quarterly clinic visit.
  2. For patients randomized to Active Medical or Placebo Medical Treatment:

    a.inability to tolerate both study medications or b.For patients treated with desipramine, i.<50% improvement in baseline GERD-HRQL score symptom after at least 10 weeks of treatment with the second drug at any quarterly clinic visit. c.For patients in whom desipramine is contraindicated,i.<50% improvement in baseline GERD-HRQL score symptom after at least 10 weeks of treatment with baclofen or its corresponding placebo at any quarterly clinic visit.

Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Medical Treatment Group Surgical Treatment Group Placebo Medical Treatment Group
Hide Arm/Group Description:

baclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals.

The dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved.

Desipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit.

Nissen fundoplication: laparoscopic antireflux surgery

baclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals.

The dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved.

Desipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit.

Overall Number of Participants Analyzed 25 27 26
Measure Type: Count of Participants
Unit of Measure: Participants
7
  28.0%
18
  66.7%
3
  11.5%
2.Secondary Outcome
Title Number of Enrolled Participants With Esophageal Ulceration.
Hide Description [Not Specified]
Time Frame Screening
Hide Outcome Measure Data
Hide Analysis Population Description
The Overall number of participants analyzed represents those Enrolled Participants who were evaluated for esophageal ulceration.
Arm/Group Title All Enrolled
Hide Arm/Group Description:
All patients consented.
Overall Number of Participants Analyzed 216
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
3.Secondary Outcome
Title Number of Enrolled Participants With Reflux Esophagus.
Hide Description [Not Specified]
Time Frame Screening
Hide Outcome Measure Data
Hide Analysis Population Description
The Overall number of participants analyzed represents those Enrolled Participants who were evaluated for reflux esophagus.
Arm/Group Title All Enrolled
Hide Arm/Group Description:
All patients consented.
Overall Number of Participants Analyzed 216
Measure Type: Count of Participants
Unit of Measure: Participants
4
   1.9%
4.Secondary Outcome
Title Number of Enrolled Participants With Eosinophilic Esophagitis
Hide Description [Not Specified]
Time Frame Screening
Hide Outcome Measure Data
Hide Analysis Population Description
The Overall number of participants analyzed represents those Enrolled Participants who were evaluated for eosinophilic esophagitis
Arm/Group Title All Enrolled
Hide Arm/Group Description:
All patients consented.
Overall Number of Participants Analyzed 215
Measure Type: Count of Participants
Unit of Measure: Participants
16
   7.4%
5.Secondary Outcome
Title Number of Enrolled Participants With Active Ulceration of the Stomach and/or Duodenum.
Hide Description [Not Specified]
Time Frame Screening
Hide Outcome Measure Data
Hide Analysis Population Description
The Overall number of participants analyzed represents those Enrolled Participants who were evaluated for active ulcerations of the stomach and/or duodenum
Arm/Group Title All Enrolled
Hide Arm/Group Description:
All patients consented.
Overall Number of Participants Analyzed 216
Measure Type: Count of Participants
Unit of Measure: Participants
3
   1.4%
6.Secondary Outcome
Title Number of Enrolled Participants With Neoplasm of the Esophagus, Stomach or Duodenum
Hide Description [Not Specified]
Time Frame Screening
Hide Outcome Measure Data
Hide Analysis Population Description
The Overall number of participants analyzed represents those Enrolled Participants who were evaluated for neoplasm of the esophagus, stomach or duodenum
Arm/Group Title All Enrolled
Hide Arm/Group Description:
All patients consented.
Overall Number of Participants Analyzed 216
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
7.Secondary Outcome
Title Number of Enrolled Participants With Candida Esophagitis.
Hide Description [Not Specified]
Time Frame Screening
Hide Outcome Measure Data
Hide Analysis Population Description
The Overall number of participants analyzed represents those Enrolled Participants who were evaluated for candida esophagitis
Arm/Group Title All Enrolled
Hide Arm/Group Description:
All patients consented.
Overall Number of Participants Analyzed 216
Measure Type: Count of Participants
Unit of Measure: Participants
3
   1.4%
8.Secondary Outcome
Title Number of Enrolled Participants With Gastric Outlet Obstruction
Hide Description [Not Specified]
Time Frame Screening
Hide Outcome Measure Data
Hide Analysis Population Description
The Overall number of participants analyzed represents those Enrolled Participants who were evaluated for gastric outlet obstruction
Arm/Group Title All Enrolled
Hide Arm/Group Description:
All patients consented.
Overall Number of Participants Analyzed 216
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
9.Secondary Outcome
Title Number of Enrolled Participants With Achalasia
Hide Description [Not Specified]
Time Frame Screening
Hide Outcome Measure Data
Hide Analysis Population Description
The Overall number of participants analyzed represents those Enrolled Participants who were evaluated for achalasia
Arm/Group Title All Enrolled
Hide Arm/Group Description:
All patients consented.
Overall Number of Participants Analyzed 212
Measure Type: Count of Participants
Unit of Measure: Participants
2
   0.9%
10.Secondary Outcome
Title Number of Enrolled Participants With Aperistalsis
Hide Description [Not Specified]
Time Frame Screening
Hide Outcome Measure Data
Hide Analysis Population Description
The Overall number of participants analyzed represents those Enrolled Participants who were evaluated for aperistalsis
Arm/Group Title All Enrolled
Hide Arm/Group Description:
All patients consented.
Overall Number of Participants Analyzed 212
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
11.Secondary Outcome
Title Number of Enrolled Participants With Distal Esophageal Spasm
Hide Description [Not Specified]
Time Frame Screening
Hide Outcome Measure Data
Hide Analysis Population Description
The Overall number of participants analyzed represents those Enrolled Participants who were evaluated for distal esophageal spasm
Arm/Group Title All Enrolled
Hide Arm/Group Description:
All patients consented.
Overall Number of Participants Analyzed 212
Measure Type: Count of Participants
Unit of Measure: Participants
3
   1.4%
12.Secondary Outcome
Title Number of Enrolled Participants With Nutcracker Esophagus
Hide Description [Not Specified]
Time Frame Screening
Hide Outcome Measure Data
Hide Analysis Population Description
The Overall number of participants analyzed represents those Enrolled Participants who were evaluated for nutcracker esophagus
Arm/Group Title All Enrolled
Hide Arm/Group Description:
All patients consented.
Overall Number of Participants Analyzed 32
Measure Type: Count of Participants
Unit of Measure: Participants
2
   6.3%
13.Secondary Outcome
Title Number of Enrolled Participants With Ineffective Esophageal Motility
Hide Description [Not Specified]
Time Frame Screening
Hide Outcome Measure Data
Hide Analysis Population Description
The Overall number of participants analyzed represents those Enrolled Participants who were evaluated for ineffective esophageal motility
Arm/Group Title All Enrolled
Hide Arm/Group Description:
All patients consented.
Overall Number of Participants Analyzed 33
Measure Type: Count of Participants
Unit of Measure: Participants
1
   3.0%
14.Secondary Outcome
Title Number of Enrolled Participants With Rapid Contraction
Hide Description [Not Specified]
Time Frame Screening
Hide Outcome Measure Data
Hide Analysis Population Description
The Overall number of participants analyzed represents those Enrolled Participants who were evaluated for rapid contraction
Arm/Group Title All Enrolled
Hide Arm/Group Description:
All patients consented.
Overall Number of Participants Analyzed 93
Measure Type: Count of Participants
Unit of Measure: Participants
2
   2.2%
15.Secondary Outcome
Title Number of Enrolled Participants With Hypertensive Peristalsis
Hide Description [Not Specified]
Time Frame Screening
Hide Outcome Measure Data
Hide Analysis Population Description
The Overall number of participants analyzed represents those Enrolled Participants who were evaluated for hypertensive peristalsis
Arm/Group Title All Enrolled
Hide Arm/Group Description:
All patients consented.
Overall Number of Participants Analyzed 93
Measure Type: Count of Participants
Unit of Measure: Participants
3
   3.2%
16.Secondary Outcome
Title Number of Enrolled Participants With Jackhammer Esophagus
Hide Description [Not Specified]
Time Frame Screening
Hide Outcome Measure Data
Hide Analysis Population Description
The Overall number of participants analyzed represents those Enrolled Participants who were evaluated for jackhammer esophagus
Arm/Group Title All Enrolled
Hide Arm/Group Description:
All patients consented.
Overall Number of Participants Analyzed 93
Measure Type: Count of Participants
Unit of Measure: Participants
8
   8.6%
17.Secondary Outcome
Title Number of Enrolled Participants With Weak Peristalsis I
Hide Description [Not Specified]
Time Frame Screening
Hide Outcome Measure Data
Hide Analysis Population Description
The Overall number of participants analyzed represents those Enrolled Participants who were evaluated for weak peristalsis I
Arm/Group Title All Enrolled
Hide Arm/Group Description:
All patients consented.
Overall Number of Participants Analyzed 93
Measure Type: Count of Participants
Unit of Measure: Participants
10
  10.8%
18.Secondary Outcome
Title Number of Enrolled Participants With Weak Peristalsis II
Hide Description [Not Specified]
Time Frame Screening
Hide Outcome Measure Data
Hide Analysis Population Description
The Overall number of participants analyzed represents those Enrolled Participants who were evaluated for weak peristalsis II
Arm/Group Title All Enrolled
Hide Arm/Group Description:
All patients consented.
Overall Number of Participants Analyzed 93
Measure Type: Count of Participants
Unit of Measure: Participants
9
   9.7%
19.Secondary Outcome
Title Number of Enrolled Participants With Anxiety and/or Depression
Hide Description [Not Specified]
Time Frame Screening
Hide Outcome Measure Data
Hide Analysis Population Description
The Overall number of participants analyzed represents those Enrolled Participants who were evaluated for anxiety and/or depression
Arm/Group Title All Enrolled
Hide Arm/Group Description:
All patients consented.
Overall Number of Participants Analyzed 272
Measure Type: Count of Participants
Unit of Measure: Participants
125
  46.0%
20.Secondary Outcome
Title Number of Enrolled Participants With Functional Heartburn
Hide Description [Not Specified]
Time Frame Screening
Hide Outcome Measure Data
Hide Analysis Population Description
The Overall number of participants analyzed represents those Enrolled Participants who were evaluated for functional heartburn
Arm/Group Title All Enrolled
Hide Arm/Group Description:
All patients consented.
Overall Number of Participants Analyzed 274
Measure Type: Count of Participants
Unit of Measure: Participants
221
  80.7%
21.Secondary Outcome
Title Number of Enrolled Participants With Functional Chest Pain of Presumed Esophageal Origin
Hide Description [Not Specified]
Time Frame Screening
Hide Outcome Measure Data
Hide Analysis Population Description
The Overall number of participants analyzed represents those Enrolled Participants who were evaluated for functional chest pain of presumed esophageal origin
Arm/Group Title All Enrolled
Hide Arm/Group Description:
All patients consented.
Overall Number of Participants Analyzed 276
Measure Type: Count of Participants
Unit of Measure: Participants
13
   4.7%
22.Secondary Outcome
Title Number of Enrolled Participants With Functional Dysphagia
Hide Description [Not Specified]
Time Frame Screening
Hide Outcome Measure Data
Hide Analysis Population Description
The Overall number of participants analyzed represents those Enrolled Participants who were evaluated for functional dysphagia
Arm/Group Title All Enrolled
Hide Arm/Group Description:
All patients consented.
Overall Number of Participants Analyzed 277
Measure Type: Count of Participants
Unit of Measure: Participants
7
   2.5%
23.Secondary Outcome
Title Number of Enrolled Participants With Globus
Hide Description [Not Specified]
Time Frame Screening
Hide Outcome Measure Data
Hide Analysis Population Description
The Overall number of participants analyzed represents those Enrolled Participants who were evaluated for globus
Arm/Group Title All Enrolled
Hide Arm/Group Description:
All patients consented.
Overall Number of Participants Analyzed 278
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
24.Secondary Outcome
Title Number of Enrolled Participants With Belching Disorders
Hide Description [Not Specified]
Time Frame Screening
Hide Outcome Measure Data
Hide Analysis Population Description
The Overall number of participants analyzed represents those Enrolled Participants who were evaluated for belching disorders
Arm/Group Title All Enrolled
Hide Arm/Group Description:
All patients consented.
Overall Number of Participants Analyzed 273
Measure Type: Count of Participants
Unit of Measure: Participants
130
  47.6%
25.Secondary Outcome
Title Number of Enrolled Participants With Chronic Idiopathic Nausea
Hide Description [Not Specified]
Time Frame Screening
Hide Outcome Measure Data
Hide Analysis Population Description
The Overall number of participants analyzed represents those Enrolled Participants who were evaluated for chronic idiopathic nausea
Arm/Group Title All Enrolled
Hide Arm/Group Description:
All patients consented.
Overall Number of Participants Analyzed 273
Measure Type: Count of Participants
Unit of Measure: Participants
51
  18.7%
26.Secondary Outcome
Title Number of Enrolled Participants With Functional Vomiting
Hide Description [Not Specified]
Time Frame Screening
Hide Outcome Measure Data
Hide Analysis Population Description
The Overall number of participants analyzed represents those Enrolled Participants who were evaluated for functional vomiting
Arm/Group Title All Enrolled
Hide Arm/Group Description:
All patients consented.
Overall Number of Participants Analyzed 276
Measure Type: Count of Participants
Unit of Measure: Participants
32
  11.6%
27.Secondary Outcome
Title Number of Enrolled Participants With Cyclic Vomiting Syndrome
Hide Description [Not Specified]
Time Frame Screening
Hide Outcome Measure Data
Hide Analysis Population Description
The Overall number of participants analyzed represents those Enrolled Participants who were evaluated for cyclic vomiting syndrome
Arm/Group Title All Enrolled
Hide Arm/Group Description:
All patients consented.
Overall Number of Participants Analyzed 276
Measure Type: Count of Participants
Unit of Measure: Participants
86
  31.2%
28.Secondary Outcome
Title Number of Enrolled Participants With Irritable Bowel Syndrome
Hide Description [Not Specified]
Time Frame Screening
Hide Outcome Measure Data
Hide Analysis Population Description
The Overall number of participants analyzed represents those Enrolled Participants who were evaluated for irritable bowel syndrome
Arm/Group Title All Enrolled
Hide Arm/Group Description:
All patients consented.
Overall Number of Participants Analyzed 277
Measure Type: Count of Participants
Unit of Measure: Participants
152
  54.9%
29.Secondary Outcome
Title Number of Enrolled Participants With Functional Bloating
Hide Description [Not Specified]
Time Frame Screening
Hide Outcome Measure Data
Hide Analysis Population Description
The Overall number of participants analyzed represents those Enrolled Participants who were evaluated for functional bloating
Arm/Group Title All Enrolled
Hide Arm/Group Description:
All patients consented.
Overall Number of Participants Analyzed 277
Measure Type: Count of Participants
Unit of Measure: Participants
8
   2.9%
30.Secondary Outcome
Title Number of Enrolled Participants With Functional Diarrhea
Hide Description [Not Specified]
Time Frame Screening
Hide Outcome Measure Data
Hide Analysis Population Description
The Overall number of participants analyzed represents those Enrolled Participants who were evaluated for functional diarrhea
Arm/Group Title All Enrolled
Hide Arm/Group Description:
All patients consented.
Overall Number of Participants Analyzed 271
Measure Type: Count of Participants
Unit of Measure: Participants
4
   1.5%
31.Secondary Outcome
Title Number of Enrolled Participants With Unspecified Functional Bowel Disorder
Hide Description [Not Specified]
Time Frame Screening
Hide Outcome Measure Data
Hide Analysis Population Description
The Overall number of participants analyzed represents those Enrolled Participants who were evaluated for unspecified functional bowel disorder
Arm/Group Title All Enrolled
Hide Arm/Group Description:
All patients consented.
Overall Number of Participants Analyzed 278
Measure Type: Count of Participants
Unit of Measure: Participants
56
  20.1%
32.Secondary Outcome
Title Number of Enrolled Participants With Functional Gallbladder Disorder
Hide Description [Not Specified]
Time Frame Screening
Hide Outcome Measure Data
Hide Analysis Population Description
The Overall number of participants analyzed represents those Enrolled Participants who were evaluated for functional gallbladder disorder
Arm/Group Title All Enrolled
Hide Arm/Group Description:
All patients consented.
Overall Number of Participants Analyzed 278
Measure Type: Count of Participants
Unit of Measure: Participants
1
   0.4%
33.Secondary Outcome
Title Number of Successful Participants With Anxiety and/or Depression.
Hide Description Association between anxiety and/or depression (GAD-7 and PHQ-9) and the outcome of medical and surgical treatments (success or failure) will be evaluated.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Number of treatment successes.
Arm/Group Title Medical Treatment Group Surgical Treatment Group Placebo Medical Treatment Group
Hide Arm/Group Description:

Omeprazole + baclofen or Omeprazole + desipramine

baclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals.

The dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved.

Desipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit.

Laparoscopic nissen fundoplications

Nissen fundoplication: laparoscopic antireflux surgery

Omeprazole + placebo

baclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals.

The dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved.

Desipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit.

Overall Number of Participants Analyzed 7 18 3
Measure Type: Count of Participants
Unit of Measure: Participants
2
  28.6%
5
  27.8%
0
   0.0%
34.Secondary Outcome
Title Number of Successful Participants With Functional Heartburn
Hide Description Presence of functional heartburn as assessed by the ROME III functional GI disorders questionnaire.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Number of treatment successes.
Arm/Group Title Medical Treatment Group Surgical Treatment Group Placebo Medical Treatment Group
Hide Arm/Group Description:

Omeprazole + baclofen or Omeprazole + desipramine

baclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals.

The dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved.

Desipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit.

Laparoscopic nissen fundoplications

Nissen fundoplication: laparoscopic antireflux surgery

Omeprazole + placebo

baclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals.

The dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved.

Desipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit.

Overall Number of Participants Analyzed 7 18 3
Measure Type: Count of Participants
Unit of Measure: Participants
7
 100.0%
14
  77.8%
3
 100.0%
35.Secondary Outcome
Title Number of Successful Participants With Functional Chest Pain of Presumed Esophageal Origin
Hide Description Presence of functional chest pain of presumed esophageal origin as assessed by the ROME III functional GI disorders questionnaire.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Number of treatment successes.
Arm/Group Title Medical Treatment Group Surgical Treatment Group Placebo Medical Treatment Group
Hide Arm/Group Description:

Omeprazole + baclofen or Omeprazole + desipramine

baclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals.

The dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved.

Desipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit.

Laparoscopic nissen fundoplications

Nissen fundoplication: laparoscopic antireflux surgery

Omeprazole + placebo

baclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals.

The dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved.

Desipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit.

Overall Number of Participants Analyzed 7 18 3
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
36.Secondary Outcome
Title Number of Successful Participants With Functional Dysphagia
Hide Description Presence of functional dysphagia as assessed by the ROME III functional GI disorders questionnaire.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Number of treatment successes.
Arm/Group Title Medical Treatment Group Surgical Treatment Group Placebo Medical Treatment Group
Hide Arm/Group Description:

Omeprazole + baclofen or Omeprazole + desipramine

baclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals.

The dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved.

Desipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit.

Laparoscopic nissen fundoplications

Nissen fundoplication: laparoscopic antireflux surgery

Omeprazole + placebo

baclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals.

The dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved.

Desipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit.

Overall Number of Participants Analyzed 7 18 3
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
37.Secondary Outcome
Title Number of Successful Participants With Globus
Hide Description Presence of globus as assessed by the ROME III functional GI disorders questionnaire.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Number of treatment successes.
Arm/Group Title Medical Treatment Group Surgical Treatment Group Placebo Medical Treatment Group
Hide Arm/Group Description:

Omeprazole + baclofen or Omeprazole + desipramine

baclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals.

The dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved.

Desipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit.

Laparoscopic nissen fundoplications

Nissen fundoplication: laparoscopic antireflux surgery

Omeprazole + placebo

baclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals.

The dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved.

Desipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit.

Overall Number of Participants Analyzed 7 18 3
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
38.Secondary Outcome
Title Number of Successful Participants With Belching Disorders
Hide Description Presence of belching disorders as assessed by the ROME III functional GI disorders questionnaire.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Number of treatment successes.
Arm/Group Title Medical Treatment Group Surgical Treatment Group Placebo Medical Treatment Group
Hide Arm/Group Description:

Omeprazole + baclofen or Omeprazole + desipramine

baclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals.

The dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved.

Desipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit.

Laparoscopic nissen fundoplications

Nissen fundoplication: laparoscopic antireflux surgery

Omeprazole + placebo

baclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals.

The dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved.

Desipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit.

Overall Number of Participants Analyzed 7 18 3
Measure Type: Count of Participants
Unit of Measure: Participants
3
  42.9%
12
  66.7%
2
  66.7%
39.Secondary Outcome
Title Number of Successful Participants With Chronic Idiopathic Nausea
Hide Description Presence of chronic idiopathic nausea as assessed by the ROME III functional GI disorders questionnaire.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Number of treatment successes.
Arm/Group Title Medical Treatment Group Surgical Treatment Group Placebo Medical Treatment Group
Hide Arm/Group Description:

Omeprazole + baclofen or Omeprazole + desipramine

baclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals.

The dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved.

Desipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit.

Laparoscopic nissen fundoplications

Nissen fundoplication: laparoscopic antireflux surgery

Omeprazole + placebo

baclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals.

The dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved.

Desipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit.

Overall Number of Participants Analyzed 7 18 3
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
3
  16.7%
0
   0.0%
40.Secondary Outcome
Title Number of Successful Participants With Functional Vomiting
Hide Description Presence of functional vomiting as assessed by the ROME III functional GI disorders questionnaire.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Number of treatment successes.
Arm/Group Title Medical Treatment Group Surgical Treatment Group Placebo Medical Treatment Group
Hide Arm/Group Description:

Omeprazole + baclofen or Omeprazole + desipramine

baclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals.

The dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved.

Desipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit.

Laparoscopic nissen fundoplications

Nissen fundoplication: laparoscopic antireflux surgery

Omeprazole + placebo

baclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals.

The dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved.

Desipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit.

Overall Number of Participants Analyzed 7 18 3
Measure Type: Count of Participants
Unit of Measure: Participants
1
  14.3%
1
   5.6%
1
  33.3%
41.Secondary Outcome
Title Number of Successful Participants With Cyclic Vomiting Syndrome
Hide Description Presence of cyclic vomiting syndrome as assessed by the ROME III functional GI disorders questionnaire.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Number of treatment successes.
Arm/Group Title Medical Treatment Group Surgical Treatment Group Placebo Medical Treatment Group
Hide Arm/Group Description:

Omeprazole + baclofen or Omeprazole + desipramine

baclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals.

The dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved.

Desipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit.

Laparoscopic nissen fundoplications

Nissen fundoplication: laparoscopic antireflux surgery

Omeprazole + placebo

baclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals.

The dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved.

Desipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit.

Overall Number of Participants Analyzed 7 18 3
Measure Type: Count of Participants
Unit of Measure: Participants
1
  14.3%
7
  38.9%
1
  33.3%
42.Secondary Outcome
Title Number of Successful Participants With Irritable Bowel Syndrome
Hide Description Presence of irritable bowel syndrome as assessed by the ROME III functional GI disorders questionnaire.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Number of treatment successes
Arm/Group Title Medical Treatment Group Surgical Treatment Group Placebo Medical Treatment Group
Hide Arm/Group Description:

Omeprazole + baclofen or Omeprazole + desipramine

baclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals.

The dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved.

Desipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit.

Laparoscopic nissen fundoplications

Nissen fundoplication: laparoscopic antireflux surgery

Omeprazole + placebo

baclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals.

The dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved.

Desipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit.

Overall Number of Participants Analyzed 7 18 3
Measure Type: Count of Participants
Unit of Measure: Participants
3
  42.9%
10
  55.6%
3
 100.0%
43.Secondary Outcome
Title Number of Successful Participants With Functional Bloating
Hide Description Presence of functional bloating as assessed by the ROME III functional GI disorders questionnaire.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Number of treatment successes.
Arm/Group Title Medical Treatment Group Surgical Treatment Group Placebo Medical Treatment Group
Hide Arm/Group Description:

Omeprazole + baclofen or Omeprazole + desipramine

baclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals.

The dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved.

Desipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit.

Laparoscopic nissen fundoplications

Nissen fundoplication: laparoscopic antireflux surgery

Omeprazole + placebo

baclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals.

The dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved.

Desipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit.

Overall Number of Participants Analyzed 7 18 3
Measure Type: Count of Participants
Unit of Measure: Participants
1
  14.3%
1
   5.6%
0
   0.0%
44.Secondary Outcome
Title Number of Successful Participants With Functional Diarrhea
Hide Description Presence of functional diarrhea as assessed by the ROME III functional GI disorders questionnaire.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Number of treatment successes
Arm/Group Title Medical Treatment Group Surgical Treatment Group Placebo Medical Treatment Group
Hide Arm/Group Description:

Omeprazole + baclofen or Omeprazole + desipramine

baclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals.

The dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved.

Desipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit.

Laparoscopic nissen fundoplications

Nissen fundoplication: laparoscopic antireflux surgery

Omeprazole + placebo

baclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals.

The dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved.

Desipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit.

Overall Number of Participants Analyzed 7 18 3
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
45.Secondary Outcome
Title Number of Successful Participants With Unspecified Functional Bowel Disorder
Hide Description Presence of unspecified functional bowel disorder as assessed by the ROME III functional GI disorders questionnaire.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Number of treatment successes.
Arm/Group Title Medical Treatment Group Surgical Treatment Group Placebo Medical Treatment Group
Hide Arm/Group Description:

Omeprazole + baclofen or Omeprazole + desipramine

baclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals.

The dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved.

Desipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit.

Laparoscopic nissen fundoplications

Nissen fundoplication: laparoscopic antireflux surgery

Omeprazole + placebo

baclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals.

The dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved.

Desipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit.

Overall Number of Participants Analyzed 7 18 3
Measure Type: Count of Participants
Unit of Measure: Participants
2
  28.6%
5
  27.8%
0
   0.0%
46.Secondary Outcome
Title Number of Successful Participants With Functional Gallbladder Disorder
Hide Description Presence of functional gallbladder disorder as assessed by the ROME III functional GI disorders questionnaire.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Number of treatment successes
Arm/Group Title Medical Treatment Group Surgical Treatment Group Placebo Medical Treatment Group
Hide Arm/Group Description:

Omeprazole + baclofen or Omeprazole + desipramine

baclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals.

The dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved.

Desipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit.

Laparoscopic nissen fundoplications

Nissen fundoplication: laparoscopic antireflux surgery

Omeprazole + placebo

baclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals.

The dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved.

Desipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit.

Overall Number of Participants Analyzed 7 18 3
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
47.Secondary Outcome
Title Number of Successful Surgery Participants With Dissection of Distal Esophagus to Obtain at Least 2.5cm of Tension-free, Intra-abdominal Esophagus Performed.
Hide Description [Not Specified]
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Surgical participants with at least 50% improvement in the baseline GERD-HRQL score at 12 months.
Arm/Group Title Surgical Treatment Group
Hide Arm/Group Description:
Nissen fundoplication: laparoscopic antireflux surgery
Overall Number of Participants Analyzed 18
Measure Type: Count of Participants
Unit of Measure: Participants
18
 100.0%
48.Secondary Outcome
Title Number of Successful Surgery Participants With Complete Mobilization of the Fundus, to Include All Short Gastric and Posterior Gastric Vessels to the Base of the Left Crus Performed.
Hide Description [Not Specified]
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Surgical participants with at least 50% improvement in the baseline GERD-HRQL score at 12 months.
Arm/Group Title Surgical Treatment Group
Hide Arm/Group Description:
Nissen fundoplication: laparoscopic antireflux surgery
Overall Number of Participants Analyzed 18
Measure Type: Count of Participants
Unit of Measure: Participants
18
 100.0%
49.Secondary Outcome
Title Number of Successful Surgery Participants With Closure of the Crura With Non-absorbable Suture to be Snug With a Dilator of at Least 56 French Diameter Performed.
Hide Description [Not Specified]
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Surgical participants with at least 50% improvement in the baseline GERD-HRQL score at 12 months.
Arm/Group Title Surgical Treatment Group
Hide Arm/Group Description:
Nissen fundoplication: laparoscopic antireflux surgery
Overall Number of Participants Analyzed 18
Measure Type: Count of Participants
Unit of Measure: Participants
14
  77.8%
50.Secondary Outcome
Title Number of Successful Surgery Participants With Passage of an Esophageal Dilator of at Least 56 French Diameter Performed.
Hide Description [Not Specified]
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Surgical participants with at least 50% improvement in the baseline GERD-HRQL score at 12 months.
Arm/Group Title Surgical Treatment Group
Hide Arm/Group Description:
Nissen fundoplication: laparoscopic antireflux surgery
Overall Number of Participants Analyzed 18
Measure Type: Count of Participants
Unit of Measure: Participants
14
  77.8%
51.Secondary Outcome
Title Number of Successful Surgery Participants With Fundoplication Between 1.5 and 2.5cm in Length Performed.
Hide Description [Not Specified]
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Surgical participants with at least 50% improvement in the baseline GERD-HRQL score at 12 months.
Arm/Group Title Surgical Treatment Group
Hide Arm/Group Description:
Nissen fundoplication: laparoscopic antireflux surgery
Overall Number of Participants Analyzed 18
Measure Type: Count of Participants
Unit of Measure: Participants
18
 100.0%
52.Secondary Outcome
Title Number of Successful Surgery Participants With Fundoplication Placed Above the Epiphrenic Fat Pad, Using 3 Sutures Performed.
Hide Description [Not Specified]
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Surgical participants with at least 50% improvement in the baseline GERD-HRQL score at 12 months.
Arm/Group Title Surgical Treatment Group
Hide Arm/Group Description:
Nissen fundoplication: laparoscopic antireflux surgery
Overall Number of Participants Analyzed 18
Measure Type: Count of Participants
Unit of Measure: Participants
18
 100.0%
53.Secondary Outcome
Title Number of Successful Surgery Participants With Fundoplication Secured to Esophagus With at Least Two Sutures Performed.
Hide Description [Not Specified]
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Surgical participants with at least 50% improvement in the baseline GERD-HRQL score at 12 months.
Arm/Group Title Surgical Treatment Group
Hide Arm/Group Description:
Nissen fundoplication: laparoscopic antireflux surgery
Overall Number of Participants Analyzed 18
Measure Type: Count of Participants
Unit of Measure: Participants
18
 100.0%
54.Secondary Outcome
Title Number of Successful Surgery Participants With Fundoplication Floppiness Demonstrated by Passing a Grasper Between Fundoplication and Dilator-filled Esophagus Performed.
Hide Description [Not Specified]
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Surgical participants with at least 50% improvement in the baseline GERD-HRQL score at 12 months.
Arm/Group Title Surgical Treatment Group
Hide Arm/Group Description:
Nissen fundoplication: laparoscopic antireflux surgery
Overall Number of Participants Analyzed 18
Measure Type: Count of Participants
Unit of Measure: Participants
15
  83.3%
Time Frame From consent to subject termination, up to 14 months.
Adverse Event Reporting Description Events reported in the all enrolled column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.
 
Arm/Group Title Medical Treatment Group Surgical Treatment Group Placebo Medical Treatment Group All Enrolled
Hide Arm/Group Description

baclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals.

The dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved.

Desipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit.

Nissen fundoplication: laparoscopic antireflux surgery

baclofen: Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals.

The dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved.

Desipramine: Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit.

All patients consented.
All-Cause Mortality
Medical Treatment Group Surgical Treatment Group Placebo Medical Treatment Group All Enrolled
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)      0/27 (0.00%)      0/26 (0.00%)      0/288 (0.00%)    
Hide Serious Adverse Events
Medical Treatment Group Surgical Treatment Group Placebo Medical Treatment Group All Enrolled
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/25 (16.00%)      4/27 (14.81%)      3/26 (11.54%)      15/366 (4.10%)    
Gastrointestinal disorders         
Pancreatitis   0/25 (0.00%)  0 0/27 (0.00%)  0 0/26 (0.00%)  0 1/366 (0.27%)  1
Diarrhoea haemorrhagic   1/25 (4.00%)  1 0/27 (0.00%)  0 0/26 (0.00%)  0 0/366 (0.00%)  0
Gastrooesophageal reflux disease   0/25 (0.00%)  0 0/27 (0.00%)  0 1/26 (3.85%)  1 0/366 (0.00%)  0
General disorders         
Chest pain   0/25 (0.00%)  0 0/27 (0.00%)  0 0/26 (0.00%)  0 1/366 (0.27%)  1
Non-cardiac chest pain   1/25 (4.00%)  1 0/27 (0.00%)  0 0/26 (0.00%)  0 1/366 (0.27%)  1
Infections and infestations         
Pneumonia   0/25 (0.00%)  0 1/27 (3.70%)  1 0/26 (0.00%)  0 0/366 (0.00%)  0
Injury, poisoning and procedural complications         
Accident   0/25 (0.00%)  0 0/27 (0.00%)  0 0/26 (0.00%)  0 1/366 (0.27%)  1
Fracture of penis   0/25 (0.00%)  0 0/27 (0.00%)  0 0/26 (0.00%)  0 1/366 (0.27%)  1
Post procedural complication   0/25 (0.00%)  0 1/27 (3.70%)  1 0/26 (0.00%)  0 0/366 (0.00%)  0
Procedural pain   0/25 (0.00%)  0 0/27 (0.00%)  0 1/26 (3.85%)  1 0/366 (0.00%)  0
Metabolism and nutrition disorders         
Hyperglycaemia   0/25 (0.00%)  0 0/27 (0.00%)  0 0/26 (0.00%)  0 1/366 (0.27%)  1
Hypoglycaemia   0/25 (0.00%)  0 0/27 (0.00%)  0 0/26 (0.00%)  0 1/366 (0.27%)  1
Musculoskeletal and connective tissue disorders         
Back pain   1/25 (4.00%)  1 0/27 (0.00%)  0 0/26 (0.00%)  0 1/366 (0.27%)  3
Arthritis   0/25 (0.00%)  0 0/27 (0.00%)  0 0/26 (0.00%)  0 1/366 (0.27%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Breast cancer   0/25 (0.00%)  0 0/27 (0.00%)  0 0/26 (0.00%)  0 1/366 (0.27%)  1
Lung neoplasm malignant   0/25 (0.00%)  0 0/27 (0.00%)  0 0/26 (0.00%)  0 1/366 (0.27%)  1
Nervous system disorders         
Migraine   0/25 (0.00%)  0 0/27 (0.00%)  0 0/26 (0.00%)  0 1/366 (0.27%)  1
Transient ischaemic attack   0/25 (0.00%)  0 0/27 (0.00%)  0 0/26 (0.00%)  0 1/366 (0.27%)  1
Psychiatric disorders         
Homicidal ideation   0/25 (0.00%)  0 0/27 (0.00%)  0 0/26 (0.00%)  0 1/366 (0.27%)  1
Depression   0/25 (0.00%)  0 0/27 (0.00%)  0 1/26 (3.85%)  1 0/366 (0.00%)  0
Post-traumatic stress disorder   1/25 (4.00%)  1 0/27 (0.00%)  0 0/26 (0.00%)  0 0/366 (0.00%)  0
Suicidal ideation   0/25 (0.00%)  0 0/27 (0.00%)  0 1/26 (3.85%)  2 0/366 (0.00%)  0
Violence-related symptom   0/25 (0.00%)  0 1/27 (3.70%)  1 0/26 (0.00%)  0 0/366 (0.00%)  0
Renal and urinary disorders         
Urinary incontinence   0/25 (0.00%)  0 0/27 (0.00%)  0 0/26 (0.00%)  0 1/366 (0.27%)  1
Nephrolithiasis   0/25 (0.00%)  0 1/27 (3.70%)  1 0/26 (0.00%)  0 0/366 (0.00%)  0
Reproductive system and breast disorders         
Erectile dysfunction   0/25 (0.00%)  0 0/27 (0.00%)  0 0/26 (0.00%)  0 1/366 (0.27%)  1
Benign prostatic hyperplasia   0/25 (0.00%)  0 1/27 (3.70%)  1 0/26 (0.00%)  0 0/366 (0.00%)  0
Vascular disorders         
Temporal arteritis   0/25 (0.00%)  0 0/27 (0.00%)  0 0/26 (0.00%)  0 1/366 (0.27%)  1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Medical Treatment Group Surgical Treatment Group Placebo Medical Treatment Group All Enrolled
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   18/25 (72.00%)      17/27 (62.96%)      18/26 (69.23%)      79/366 (21.58%)    
Blood and lymphatic system disorders         
Basophilia   1/25 (4.00%)  1 0/27 (0.00%)  0 0/26 (0.00%)  0 0/366 (0.00%)  0
Lymphadenopathy   0/25 (0.00%)  0 1/27 (3.70%)  1 0/26 (0.00%)  0 0/366 (0.00%)  0
Macrocytosis   0/25 (0.00%)  0 0/27 (0.00%)  0 1/26 (3.85%)  1 0/366 (0.00%)  0
Microcytic anaemia   1/25 (4.00%)  1 0/27 (0.00%)  0 0/26 (0.00%)  0 0/366 (0.00%)  0
Cardiac disorders         
Palpitations   0/25 (0.00%)  0 1/27 (3.70%)  1 0/26 (0.00%)  0 0/366 (0.00%)  0
Ear and labyrinth disorders         
Vertigo   1/25 (4.00%)  1 0/27 (0.00%)  0 0/26 (0.00%)  0 0/366 (0.00%)  0
Endocrine disorders         
Hyperparathyroidism   0/25 (0.00%)  0 0/27 (0.00%)  0 0/26 (0.00%)  0 1/366 (0.27%)  1
Thyroid mass   0/25 (0.00%)  0 0/27 (0.00%)  0 0/26 (0.00%)  0 1/366 (0.27%)  1
Eye disorders         
Dacryoadenitis acquired   0/25 (0.00%)  0 1/27 (3.70%)  1 0/26 (0.00%)  0 0/366 (0.00%)  0
Gastrointestinal disorders         
Diarrhoea   3/25 (12.00%)  4 1/27 (3.70%)  1 1/26 (3.85%)  1 9/366 (2.46%)  9
Dyspepsia   2/25 (8.00%)  2 1/27 (3.70%)  1 2/26 (7.69%)  2 8/366 (2.19%)  8
Gastrooesophageal reflux disease   1/25 (4.00%)  1 0/27 (0.00%)  0 1/26 (3.85%)  2 3/366 (0.82%)  3
Vomiting   0/25 (0.00%)  0 1/27 (3.70%)  1 2/26 (7.69%)  2 3/366 (0.82%)  3
Abdominal pain   0/25 (0.00%)  0 1/27 (3.70%)  1 0/26 (0.00%)  0 2/366 (0.55%)  2
Abdominal pain upper   1/25 (4.00%)  1 0/27 (0.00%)  0 1/26 (3.85%)  1 2/366 (0.55%)  2
Flatulence   0/25 (0.00%)  0 2/27 (7.41%)  2 0/26 (0.00%)  0 2/366 (0.55%)  2
Nausea   2/25 (8.00%)  2 0/27 (0.00%)  0 0/26 (0.00%)  0 2/366 (0.55%)  2
Dysphagia   0/25 (0.00%)  0 4/27 (14.81%)  5 1/26 (3.85%)  1 1/366 (0.27%)  1
Faeces hard   0/25 (0.00%)  0 0/27 (0.00%)  0 0/26 (0.00%)  0 1/366 (0.27%)  1
Faeces soft   0/25 (0.00%)  0 0/27 (0.00%)  0 0/26 (0.00%)  0 1/366 (0.27%)  1
Food poisoning   0/25 (0.00%)  0 0/27 (0.00%)  0 0/26 (0.00%)  0 1/366 (0.27%)  1
Gingival swelling   0/25 (0.00%)  0 0/27 (0.00%)  0 0/26 (0.00%)  0 1/366 (0.27%)  1
Haematochezia   0/25 (0.00%)  0 0/27 (0.00%)  0 0/26 (0.00%)  0 1/366 (0.27%)  1
Haemorrhoidal haemorrhage   0/25 (0.00%)  0 0/27 (0.00%)  0 0/26 (0.00%)  0 1/366 (0.27%)  1
Odynophagia   0/25 (0.00%)  0 1/27 (3.70%)  1 0/26 (0.00%)  0 1/366 (0.27%)  1
Tooth loss   0/25 (0.00%)  0 0/27 (0.00%)  0 0/26 (0.00%)  0 1/366 (0.27%)  1
Abdominal discomfort   0/25 (0.00%)  0 0/27 (0.00%)  0 1/26 (3.85%)  1 0/366 (0.00%)  0
Abdominal distension   2/25 (8.00%)  2 2/27 (7.41%)  2 0/26 (0.00%)  0 0/366 (0.00%)  0
Abdominal pain lower   0/25 (0.00%)  0 0/27 (0.00%)  0 1/26 (3.85%)  1 0/366 (0.00%)  0
Constipation   2/25 (8.00%)  2 1/27 (3.70%)  1 3/26 (11.54%)  3 0/366 (0.00%)  0
Cyclic vomiting syndrome   0/25 (0.00%)  0 0/27 (0.00%)  0 1/26 (3.85%)  1 0/366 (0.00%)  0
Impaired gastric emptying   0/25 (0.00%)  0 1/27 (3.70%)  1 0/26 (0.00%)  0 0/366 (0.00%)  0
Irritable bowel syndrome   1/25 (4.00%)  1 0/27 (0.00%)  0 0/26 (0.00%)  0 0/366 (0.00%)  0
Rectal haemorrhage   0/25 (0.00%)  0 1/27 (3.70%)  1 0/26 (0.00%)  0 0/366 (0.00%)  0
Regurgitation   1/25 (4.00%)  1 0/27 (0.00%)  0 0/26 (0.00%)  0 0/366 (0.00%)  0
Toothache   0/25 (0.00%)  0 0/27 (0.00%)  0 1/26 (3.85%)  1 0/366 (0.00%)  0
General disorders         
Chest pain   0/25 (0.00%)  0 1/27 (3.70%)  1 1/26 (3.85%)  2 3/366 (0.82%)  3
Chest discomfort   0/25 (0.00%)  0 0/27 (0.00%)  0 0/26 (0.00%)  0 1/366 (0.27%)  1
Fatigue   2/25 (8.00%)  2 0/27 (0.00%)  0 1/26 (3.85%)  1 1/366 (0.27%)  1
Infusion site pain   0/25 (0.00%)  0 0/27 (0.00%)  0 0/26 (0.00%)  0 1/366 (0.27%)  1
Cyst   0/25 (0.00%)  0 1/27 (3.70%)  1 0/26 (0.00%)  0 0/366 (0.00%)  0
Feeling jittery   1/25 (4.00%)  1 0/27 (0.00%)  0 0/26 (0.00%)  0 0/366 (0.00%)  0
Influenza like illness   1/25 (4.00%)  1 0/27 (0.00%)  0 0/26 (0.00%)  0 0/366 (0.00%)  0
Mucosal pain   1/25 (4.00%)  1 0/27 (0.00%)  0 0/26 (0.00%)  0 0/366 (0.00%)  0
Non-cardiac chest pain   0/25 (0.00%)  0 1/27 (3.70%)  1 0/26 (0.00%)  0 0/366 (0.00%)  0
Hepatobiliary disorders         
Hepatic steatosis   0/25 (0.00%)  0 0/27 (0.00%)  0 0/26 (0.00%)  0 1/366 (0.27%)  1
Immune system disorders         
Seasonal allergy   1/25 (4.00%)  1 0/27 (0.00%)  0 0/26 (0.00%)  0 1/366 (0.27%)  1
Infections and infestations         
Influenza   1/25 (4.00%)  1 2/27 (7.41%)  2 1/26 (3.85%)  1 2/366 (0.55%)  2
Bronchitis   0/25 (0.00%)  0 0/27 (0.00%)  0 0/26 (0.00%)  0 1/366 (0.27%)  1
Diverticulitis   0/25 (0.00%)  0 0/27 (0.00%)  0 0/26 (0.00%)  0 1/366 (0.27%)  1
Nasopharyngitis   0/25 (0.00%)  0 0/27 (0.00%)  0 2/26 (7.69%)  2 1/366 (0.27%)  1
Pharyngitis streptococcal   0/25 (0.00%)  0 0/27 (0.00%)  0 0/26 (0.00%)  0 1/366 (0.27%)  1
Tooth infection   0/25 (0.00%)  0 0/27 (0.00%)  0 0/26 (0.00%)  0 1/366 (0.27%)  1
Upper respiratory tract infection   0/25 (0.00%)  0 0/27 (0.00%)  0 2/26 (7.69%)  2 1/366 (0.27%)  1
Urethritis   0/25 (0.00%)  0 0/27 (0.00%)  0 0/26 (0.00%)  0 1/366 (0.27%)  1
Cellulitis   1/25 (4.00%)  1 0/27 (0.00%)  0 0/26 (0.00%)  0 0/366 (0.00%)  0
Clostridium difficile colitis   0/25 (0.00%)  0 0/27 (0.00%)  0 1/26 (3.85%)  1 0/366 (0.00%)  0
Conjunctivitis   0/25 (0.00%)  0 0/27 (0.00%)  0 1/26 (3.85%)  1 0/366 (0.00%)  0
Gastroenteritis   1/25 (4.00%)  1 0/27 (0.00%)  0 0/26 (0.00%)  0 0/366 (0.00%)  0
Sinusitis   0/25 (0.00%)  0 1/27 (3.70%)  1 1/26 (3.85%)  1 0/366 (0.00%)  0
Subcutaneous abscess   0/25 (0.00%)  0 0/27 (0.00%)  0 1/26 (3.85%)  1 0/366 (0.00%)  0
Urinary tract infection   0/25 (0.00%)  0 1/27 (3.70%)  2 0/26 (0.00%)  0 0/366 (0.00%)  0
Injury, poisoning and procedural complications         
Fall   1/25 (4.00%)  1 1/27 (3.70%)  1 1/26 (3.85%)  1 3/366 (0.82%)  3
Post procedural discomfort   0/25 (0.00%)  0 1/27 (3.70%)  1 1/26 (3.85%)  1 3/366 (0.82%)  3
Procedural pain   0/25 (0.00%)  0 0/27 (0.00%)  0 0/26 (0.00%)  0 3/366 (0.82%)  3
Animal bite   0/25 (0.00%)  0 0/27 (0.00%)  0 0/26 (0.00%)  0 1/366 (0.27%)  1
Arthropod bite   0/25 (0.00%)  0 0/27 (0.00%)  0 0/26 (0.00%)  0 1/366 (0.27%)  1
Injury   0/25 (0.00%)  0 0/27 (0.00%)  0 0/26 (0.00%)  0 1/366 (0.27%)  1
Post procedural complication   0/25 (0.00%)  0 0/27 (0.00%)  0 0/26 (0.00%)  0 1/366 (0.27%)  1
Ankle fracture   0/25 (0.00%)  0 1/27 (3.70%)  1 0/26 (0.00%)  0 0/366 (0.00%)  0
Joint injury   0/25 (0.00%)  0 1/27 (3.70%)  1 1/26 (3.85%)  1 0/366 (0.00%)  0
Investigations         
Laboratory test   0/25 (0.00%)  0 0/27 (0.00%)  0 0/26 (0.00%)  0 1/366 (0.27%)  1
Blood HIV RNA increased   0/25 (0.00%)  0 1/27 (3.70%)  1 0/26 (0.00%)  0 0/366 (0.00%)  0
Blood glucose increased   0/25 (0.00%)  0 0/27 (0.00%)  0 1/26 (3.85%)  1 0/366 (0.00%)  0
Blood magnesium decreased   1/25 (4.00%)  1 0/27 (0.00%)  0 0/26 (0.00%)  0 0/366 (0.00%)  0
Hepatic enzyme increased   0/25 (0.00%)  0 0/27 (0.00%)  0 1/26 (3.85%)  1 0/366 (0.00%)  0
Intraocular pressure increased   1/25 (4.00%)  1 0/27 (0.00%)  0 0/26 (0.00%)  0 0/366 (0.00%)  0
Liver function test abnormal   1/25 (4.00%)  1 0/27 (0.00%)  0 0/26 (0.00%)  0 0/366 (0.00%)  0
Weight increased   1/25 (4.00%)  1 0/27 (0.00%)  0 0/26 (0.00%)  0 0/366 (0.00%)  0
Metabolism and nutrition disorders         
Decreased appetite   1/25 (4.00%)  1 0/27 (0.00%)  0 0/26 (0.00%)  0 0/366 (0.00%)  0
Gout   0/25 (0.00%)  0 1/27 (3.70%)  1 0/26 (0.00%)  0 0/366 (0.00%)  0
Hyperkalaemia   1/25 (4.00%)  1 0/27 (0.00%)  0 0/26 (0.00%)  0 0/366 (0.00%)  0
Increased appetite   1/25 (4.00%)  1 0/27 (0.00%)  0 0/26 (0.00%)  0 0/366 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Back pain   1/25 (4.00%)  1 0/27 (0.00%)  0 0/26 (0.00%)  0 4/366 (1.09%)  6
Costochondritis   0/25 (0.00%)  0 0/27 (0.00%)  0 0/26 (0.00%)  0 1/366 (0.27%)  1
Groin pain   0/25 (0.00%)  0 0/27 (0.00%)  0 0/26 (0.00%)  0 1/366 (0.27%)  1
Musculoskeletal chest pain   0/25 (0.00%)  0 0/27 (0.00%)  0 0/26 (0.00%)  0 1/366 (0.27%)  1
Plantar fasciitis   0/25 (0.00%)  0 1/27 (3.70%)  1 0/26 (0.00%)  0 1/366 (0.27%)  1
Tendonitis   0/25 (0.00%)  0 0/27 (0.00%)  0 0/26 (0.00%)  0 1/366 (0.27%)  1
Muscle spasms   1/25 (4.00%)  1 0/27 (0.00%)  0 0/26 (0.00%)  0 0/366 (0.00%)  0
Musculoskeletal pain   0/25 (0.00%)  0 1/27 (3.70%)  1 0/26 (0.00%)  0 0/366 (0.00%)  0
Myalgia   0/25 (0.00%)  0 1/27 (3.70%)  1 0/26 (0.00%)  0 0/366 (0.00%)  0
Neck pain   0/25 (0.00%)  0 1/27 (3.70%)  1 0/26 (0.00%)  0 0/366 (0.00%)  0
Synovial cyst   1/25 (4.00%)  1 0/27 (0.00%)  0 0/26 (0.00%)  0 0/366 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Lipoma   1/25 (4.00%)  1 0/27 (0.00%)  0 0/26 (0.00%)  0 0/366 (0.00%)  0
Nervous system disorders         
Headache   0/25 (0.00%)  0 0/27 (0.00%)  0 1/26 (3.85%)  1 4/366 (1.09%)  4
Dizziness   1/25 (4.00%)  1 0/27 (0.00%)  0 0/26 (0.00%)  0 3/366 (0.82%)  3
Migraine   0/25 (0.00%)  0 0/27 (0.00%)  0 0/26 (0.00%)  0 1/366 (0.27%)  1
Sciatica   0/25 (0.00%)  0 1/27 (3.70%)  1 0/26 (0.00%)  0 1/366 (0.27%)  1
Amnesia   1/25 (4.00%)  1 0/27 (0.00%)  0 0/26 (0.00%)  0 0/366 (0.00%)  0
Carpal tunnel syndrome   0/25 (0.00%)  0 0/27 (0.00%)  0 1/26 (3.85%)  1 0/366 (0.00%)  0
Essential tremor   0/25 (0.00%)  0 0/27 (0.00%)  0 1/26 (3.85%)  1 0/366 (0.00%)  0
Hypoaesthesia   1/25 (4.00%)  1 0/27 (0.00%)  0 0/26 (0.00%)  0 0/366 (0.00%)  0
Neuropathy peripheral   1/25 (4.00%)  2 0/27 (0.00%)  0 0/26 (0.00%)  0 0/366 (0.00%)  0
Paraesthesia   1/25 (4.00%)  1 0/27 (0.00%)  0 0/26 (0.00%)  0 0/366 (0.00%)  0
Somnolence   4/25 (16.00%)  4 0/27 (0.00%)  0 1/26 (3.85%)  1 0/366 (0.00%)  0
Psychiatric disorders         
Anxiety   1/25 (4.00%)  1 0/27 (0.00%)  0 1/26 (3.85%)  1 0/366 (0.00%)  0
Depression   2/25 (8.00%)  2 0/27 (0.00%)  0 0/26 (0.00%)  0 0/366 (0.00%)  0
Hallucination, visual   1/25 (4.00%)  1 0/27 (0.00%)  0 0/26 (0.00%)  0 0/366 (0.00%)  0
Insomnia   1/25 (4.00%)  1 0/27 (0.00%)  0 1/26 (3.85%)  1 0/366 (0.00%)  0
Mood altered   0/25 (0.00%)  0 0/27 (0.00%)  0 1/26 (3.85%)  1 0/366 (0.00%)  0
Sleep disorder   1/25 (4.00%)  1 0/27 (0.00%)  0 0/26 (0.00%)  0 0/366 (0.00%)  0
Renal and urinary disorders         
Nephrolithiasis   0/25 (0.00%)  0 0/27 (0.00%)  0 0/26 (0.00%)  0 1/366 (0.27%)  1
Urinary retention   0/25 (0.00%)  0 1/27 (3.70%)  1 0/26 (0.00%)  0 0/366 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Cough   0/25 (0.00%)  0 0/27 (0.00%)  0 1/26 (3.85%)  1 3/366 (0.82%)  3
Oropharyngeal pain   0/25 (0.00%)  0 0/27 (0.00%)  0 1/26 (3.85%)  1 2/366 (0.55%)  2
Dyspnoea   0/25 (0.00%)  0 0/27 (0.00%)  0 0/26 (0.00%)  0 1/366 (0.27%)  1
Laryngospasm   0/25 (0.00%)  0 0/27 (0.00%)  0 0/26 (0.00%)  0 1/366 (0.27%)  1
Throat irritation   0/25 (0.00%)  0 0/27 (0.00%)  0 0/26 (0.00%)  0 1/366 (0.27%)  1
Dyspnoea exertional   0/25 (0.00%)  0 1/27 (3.70%)  1 0/26 (0.00%)  0 0/366 (0.00%)  0
Hiccups   0/25 (0.00%)  0 1/27 (3.70%)  1 0/26 (0.00%)  0 0/366 (0.00%)  0
Rhinitis allergic   1/25 (4.00%)  1 0/27 (0.00%)  0 0/26 (0.00%)  0 0/366 (0.00%)  0
Tonsillar disorder   0/25 (0.00%)  0 1/27 (3.70%)  1 0/26 (0.00%)  0 0/366 (0.00%)  0
Upper respiratory tract congestion   0/25 (0.00%)  0 1/27 (3.70%)  1 0/26 (0.00%)  0 0/366 (0.00%)  0
Upper-airway cough syndrome   0/25 (0.00%)  0 1/27 (3.70%)  1 0/26 (0.00%)  0 0/366 (0.00%)  0
Skin and subcutaneous tissue disorders         
Pruritus   0/25 (0.00%)  0 0/27 (0.00%)  0 0/26 (0.00%)  0 2/366 (0.55%)  2
Hyperhidrosis   0/25 (0.00%)  0 1/27 (3.70%)  1 0/26 (0.00%)  0 0/366 (0.00%)  0
Rash   0/25 (0.00%)  0 1/27 (3.70%)  1 0/26 (0.00%)  0 0/366 (0.00%)  0
Skin lesion   0/25 (0.00%)  0 1/27 (3.70%)  1 0/26 (0.00%)  0 0/366 (0.00%)  0
Vascular disorders         
Deep vein thrombosis   0/25 (0.00%)  0 0/27 (0.00%)  0 0/26 (0.00%)  0 1/366 (0.27%)  1
Hot flush   0/25 (0.00%)  0 1/27 (3.70%)  1 0/26 (0.00%)  0 0/366 (0.00%)  0
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Stuart Spechler
Organization: Dallas VA Medical Center
EMail: sjspechler@aol.com
Layout table for additonal information
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01265550    
Other Study ID Numbers: 573
First Submitted: December 21, 2010
First Posted: December 23, 2010
Results First Submitted: December 21, 2017
Results First Posted: February 26, 2018
Last Update Posted: January 22, 2020