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Trial record 28 of 47 for:    DESIPRAMINE

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 : May 1, 2019
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 78
Recruitment Details  
Pre-assignment Details  
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.

Period Title: Overall Study
Started 25 27 26
Completed 10 19 6
Not Completed 15 8 20
Arm/Group Title Medical Treatment Group Surgical Treatment Group Placebo Medical Treatment Group 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.

Total of all reporting groups
Overall Number of Baseline Participants 25 27 26 78
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 25 participants 27 participants 26 participants 78 participants
43.9  (12.2) 44.9  (11.8) 47.2  (11.7) 45.4  (11.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 27 participants 26 participants 78 participants
Female
7
  28.0%
4
  14.8%
3
  11.5%
14
  17.9%
Male
18
  72.0%
23
  85.2%
23
  88.5%
64
  82.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 27 participants 26 participants 78 participants
Hispanic or Latino
4
  16.0%
7
  25.9%
2
   7.7%
13
  16.7%
Not Hispanic or Latino
21
  84.0%
20
  74.1%
23
  88.5%
64
  82.1%
Unknown or Not Reported
0
   0.0%
0
   0.0%
1
   3.8%
1
   1.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 27 participants 26 participants 78 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
1
   3.8%
1
   1.3%
Black or African American
2
   8.0%
2
   7.4%
5
  19.2%
9
  11.5%
White
20
  80.0%
17
  63.0%
17
  65.4%
54
  69.2%
More than one race
2
   8.0%
2
   7.4%
2
   7.7%
6
   7.7%
Unknown or Not Reported
1
   4.0%
6
  22.2%
1
   3.8%
8
  10.3%
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 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%
3.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%
4.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%
5.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%
6.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%
7.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%
8.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%
9.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%
10.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%
11.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%
12.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%
13.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%
14.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%
15.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%
Time Frame From consent to subject termination, up to 14 months.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Medical Treatment Group Surgical Treatment Group Placebo Medical Treatment Group
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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-Cause Mortality
Medical Treatment Group Surgical Treatment Group Placebo Medical Treatment Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)      0/27 (0.00%)      0/26 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Medical Treatment Group Surgical Treatment Group Placebo Medical Treatment Group
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%)    
Gastrointestinal disorders       
Diarrhoea haemorrhagic   1/25 (4.00%)  1 0/27 (0.00%)  0 0/26 (0.00%)  0
Gastrooesophageal reflux disease   0/25 (0.00%)  0 0/27 (0.00%)  0 1/26 (3.85%)  1
General disorders       
Non-cardiac chest pain   1/25 (4.00%)  1 0/27 (0.00%)  0 0/26 (0.00%)  0
Infections and infestations       
Pneumonia   0/25 (0.00%)  0 1/27 (3.70%)  1 0/26 (0.00%)  0
Injury, poisoning and procedural complications       
Post procedural complication   0/25 (0.00%)  0 1/27 (3.70%)  1 0/26 (0.00%)  0
Procedural pain   0/25 (0.00%)  0 0/27 (0.00%)  0 1/26 (3.85%)  1
Musculoskeletal and connective tissue disorders       
Back pain   1/25 (4.00%)  1 0/27 (0.00%)  0 0/26 (0.00%)  0
Psychiatric disorders       
Suicidal ideation   0/25 (0.00%)  0 0/27 (0.00%)  0 1/26 (3.85%)  2
Depression   0/25 (0.00%)  0 0/27 (0.00%)  0 1/26 (3.85%)  1
Post-traumatic stress disorder   1/25 (4.00%)  1 0/27 (0.00%)  0 0/26 (0.00%)  0
Violence-related symptom   0/25 (0.00%)  0 1/27 (3.70%)  1 0/26 (0.00%)  0
Renal and urinary disorders       
Nephrolithiasis   0/25 (0.00%)  0 1/27 (3.70%)  1 0/26 (0.00%)  0
Reproductive system and breast disorders       
Benign prostatic hyperplasia   0/25 (0.00%)  0 1/27 (3.70%)  1 0/26 (0.00%)  0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events 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
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   18/25 (72.00%)      16/27 (59.26%)      18/26 (69.23%)    
Blood and lymphatic system disorders       
Basophilia   1/25 (4.00%)  1 0/27 (0.00%)  0 1/26 (3.85%)  1
Lymphadenopathy   0/25 (0.00%)  0 1/27 (3.70%)  1 0/26 (0.00%)  0
Macrocytosis   0/25 (0.00%)  0 0/27 (0.00%)  0 0/26 (0.00%)  0
Microcytic anaemia   1/25 (4.00%)  1 0/27 (0.00%)  0 1/26 (3.85%)  1
Cardiac disorders       
Palpitations   0/25 (0.00%)  0 1/27 (3.70%)  1 0/26 (0.00%)  0
Ear and labyrinth disorders       
Vertigo   1/25 (4.00%)  1 0/27 (0.00%)  0 1/26 (3.85%)  1
Eye disorders       
Dacryoadenitis acquired   0/25 (0.00%)  0 1/27 (3.70%)  1 0/26 (0.00%)  0
Gastrointestinal disorders       
Diarrhoea   3/25 (12.00%)  4 1/27 (3.70%)  1 3/26 (11.54%)  4
Dysphagia   0/25 (0.00%)  0 4/27 (14.81%)  5 0/26 (0.00%)  0
Constipation   2/25 (8.00%)  2 0/27 (0.00%)  0 2/26 (7.69%)  2
Dyspepsia   2/25 (8.00%)  2 1/27 (3.70%)  1 2/26 (7.69%)  2
Abdominal distension   2/25 (8.00%)  2 2/27 (7.41%)  2 2/26 (7.69%)  2
Gastrooesophageal reflux disease   1/25 (4.00%)  1 0/27 (0.00%)  0 1/26 (3.85%)  1
Vomiting   0/25 (0.00%)  0 1/27 (3.70%)  1 0/26 (0.00%)  0
Abdominal pain upper   1/25 (4.00%)  1 0/27 (0.00%)  0 1/26 (3.85%)  1
Flatulence   0/25 (0.00%)  0 2/27 (7.41%)  2 0/26 (0.00%)  0
Nausea   2/25 (8.00%)  2 0/27 (0.00%)  0 2/26 (7.69%)  2
Abdominal discomfort   0/25 (0.00%)  0 0/27 (0.00%)  0 0/26 (0.00%)  0
Abdominal pain   0/25 (0.00%)  0 1/27 (3.70%)  1 0/26 (0.00%)  0
Abdominal pain lower   0/25 (0.00%)  0 0/27 (0.00%)  0 0/26 (0.00%)  0
Cyclic vomiting syndrome   0/25 (0.00%)  0 0/27 (0.00%)  0 0/26 (0.00%)  0
Impaired gastric emptying   0/25 (0.00%)  0 1/27 (3.70%)  1 0/26 (0.00%)  0
Irritable bowel syndrome   1/25 (4.00%)  1 0/27 (0.00%)  0 1/26 (3.85%)  1
Odynophagia   0/25 (0.00%)  0 1/27 (3.70%)  1 0/26 (0.00%)  0
Rectal haemorrhage   0/25 (0.00%)  0 1/27 (3.70%)  1 0/26 (0.00%)  0
Regurgitation   1/25 (4.00%)  1 0/27 (0.00%)  0 1/26 (3.85%)  1
Toothache   0/25 (0.00%)  0 0/27 (0.00%)  0 0/26 (0.00%)  0
General disorders       
Chest pain   0/25 (0.00%)  0 1/27 (3.70%)  1 0/26 (0.00%)  0
Fatigue   2/25 (8.00%)  2 0/27 (0.00%)  0 2/26 (7.69%)  2
Cyst   0/25 (0.00%)  0 1/27 (3.70%)  1 0/26 (0.00%)  0
Feeling jittery   1/25 (4.00%)  1 0/27 (0.00%)  0 1/26 (3.85%)  1
Influenza like illness   1/25 (4.00%)  1 0/27 (0.00%)  0 1/26 (3.85%)  1
Mucosal pain   1/25 (4.00%)  1 0/27 (0.00%)  0 1/26 (3.85%)  1
Non-cardiac chest pain   0/25 (0.00%)  0 1/27 (3.70%)  1 0/26 (0.00%)  0
Immune system disorders       
Seasonal allergy   1/25 (4.00%)  1 0/27 (0.00%)  0 1/26 (3.85%)  1
Infections and infestations       
Influenza   1/25 (4.00%)  1 2/27 (7.41%)  2 1/26 (3.85%)  1
Nasopharyngitis   0/25 (0.00%)  0 0/27 (0.00%)  0 0/26 (0.00%)  0
Sinusitis   0/25 (0.00%)  0 1/27 (3.70%)  1 0/26 (0.00%)  0
Upper respiratory tract infection   0/25 (0.00%)  0 0/27 (0.00%)  0 0/26 (0.00%)  0
Urinary tract infection   0/25 (0.00%)  0 1/27 (3.70%)  2 0/26 (0.00%)  0
Cellulitis   1/25 (4.00%)  1 0/27 (0.00%)  0 1/26 (3.85%)  1
Clostridium difficile colitis   0/25 (0.00%)  0 0/27 (0.00%)  0 0/26 (0.00%)  0
Conjunctivitis   0/25 (0.00%)  0 0/27 (0.00%)  0 0/26 (0.00%)  0
Gastroenteritis   1/25 (4.00%)  1 0/27 (0.00%)  0 1/26 (3.85%)  1
Subcutaneous abscess   0/25 (0.00%)  0 0/27 (0.00%)  0 0/26 (0.00%)  0
Injury, poisoning and procedural complications       
Fall   1/25 (4.00%)  1 1/27 (3.70%)  1 1/26 (3.85%)  1
Joint injury   0/25 (0.00%)  0 1/27 (3.70%)  1 0/26 (0.00%)  0
Post procedural discomfort   0/25 (0.00%)  0 1/27 (3.70%)  1 0/26 (0.00%)  0
Ankle fracture   0/25 (0.00%)  0 1/27 (3.70%)  1 0/26 (0.00%)  0
Investigations       
Blood HIV RNA increased   0/25 (0.00%)  0 1/27 (3.70%)  1 0/26 (0.00%)  0
Blood glucose increased   0/25 (0.00%)  0 0/27 (0.00%)  0 0/26 (0.00%)  0
Blood magnesium decreased   1/25 (4.00%)  1 0/27 (0.00%)  0 1/26 (3.85%)  1
Hepatic enzyme increased   0/25 (0.00%)  0 0/27 (0.00%)  0 0/26 (0.00%)  0
Intraocular pressure increased   1/25 (4.00%)  1 0/27 (0.00%)  0 1/26 (3.85%)  1
Liver function test abnormal   1/25 (4.00%)  1 0/27 (0.00%)  0 1/26 (3.85%)  1
Weight increased   1/25 (4.00%)  1 0/27 (0.00%)  0 1/26 (3.85%)  1
Metabolism and nutrition disorders       
Decreased appetite   1/25 (4.00%)  1 0/27 (0.00%)  0 1/26 (3.85%)  1
Gout   0/25 (0.00%)  0 1/27 (3.70%)  1 0/26 (0.00%)  0
Hyperkalaemia   1/25 (4.00%)  1 0/27 (0.00%)  0 1/26 (3.85%)  1
Increased appetite   1/25 (4.00%)  1 0/27 (0.00%)  0 1/26 (3.85%)  1
Musculoskeletal and connective tissue disorders       
Back pain   1/25 (4.00%)  1 0/27 (0.00%)  0 1/26 (3.85%)  1
Muscle spasms   1/25 (4.00%)  1 0/27 (0.00%)  0 1/26 (3.85%)  1
Musculoskeletal pain   0/25 (0.00%)  0 1/27 (3.70%)  1 0/26 (0.00%)  0
Myalgia   0/25 (0.00%)  0 1/27 (3.70%)  1 0/26 (0.00%)  0
Neck pain   0/25 (0.00%)  0 1/27 (3.70%)  1 0/26 (0.00%)  0
Plantar fasciitis   0/25 (0.00%)  0 1/27 (3.70%)  1 0/26 (0.00%)  0
Synovial cyst   1/25 (4.00%)  1 0/27 (0.00%)  0 1/26 (3.85%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Lipoma   1/25 (4.00%)  1 0/27 (0.00%)  0 1/26 (3.85%)  1
Nervous system disorders       
Somnolence   4/25 (16.00%)  4 0/27 (0.00%)  0 4/26 (15.38%)  4
Amnesia   1/25 (4.00%)  1 0/27 (0.00%)  0 1/26 (3.85%)  1
Carpal tunnel syndrome   0/25 (0.00%)  0 0/27 (0.00%)  0 0/26 (0.00%)  0
Dizziness   1/25 (4.00%)  1 0/27 (0.00%)  0 1/26 (3.85%)  1
Essential tremor   0/25 (0.00%)  0 0/27 (0.00%)  0 0/26 (0.00%)  0
Headache   0/25 (0.00%)  0 0/27 (0.00%)  0 0/26 (0.00%)  0
Hypoaesthesia   1/25 (4.00%)  1 0/27 (0.00%)  0 1/26 (3.85%)  1
Neuropathy peripheral   1/25 (4.00%)  1 0/27 (0.00%)  0 1/26 (3.85%)  1
Paraesthesia   1/25 (4.00%)  1 0/27 (0.00%)  0 1/26 (3.85%)  1
Sciatica   0/25 (0.00%)  0 1/27 (3.70%)  1 0/26 (0.00%)  0
Psychiatric disorders       
Anxiety   1/25 (4.00%)  1 0/27 (0.00%)  0 1/26 (3.85%)  1
Depression   2/25 (8.00%)  2 0/27 (0.00%)  0 2/26 (7.69%)  2
Insomnia   1/25 (4.00%)  1 0/27 (0.00%)  0 1/26 (3.85%)  1
Hallucination, visual   1/25 (4.00%)  1 0/27 (0.00%)  0 1/26 (3.85%)  1
Mood altered   0/25 (0.00%)  0 0/27 (0.00%)  0 0/26 (0.00%)  0
Sleep disorder   1/25 (4.00%)  1 0/27 (0.00%)  0 1/26 (3.85%)  1
Renal and urinary disorders       
Urinary retention   0/25 (0.00%)  0 1/27 (3.70%)  1 0/26 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Cough   0/25 (0.00%)  0 0/27 (0.00%)  0 0/26 (0.00%)  0
Dyspnoea exertional   0/25 (0.00%)  0 1/27 (3.70%)  1 0/26 (0.00%)  0
Oropharyngeal pain   0/25 (0.00%)  0 0/27 (0.00%)  0 0/26 (0.00%)  0
Rhinitis allergic   1/25 (4.00%)  1 0/27 (0.00%)  0 1/26 (3.85%)  1
Tonsillar disorder   0/25 (0.00%)  0 1/27 (3.70%)  1 0/26 (0.00%)  0
Upper respiratory tract congestion   0/25 (0.00%)  0 1/27 (3.70%)  1 0/26 (0.00%)  0
Upper-airway cough syndrome   0/25 (0.00%)  0 1/27 (3.70%)  1 0/26 (0.00%)  0
Skin and subcutaneous tissue disorders       
Hyperhidrosis   0/25 (0.00%)  0 1/27 (3.70%)  1 0/26 (0.00%)  0
Rash   0/25 (0.00%)  0 1/27 (3.70%)  1 0/26 (0.00%)  0
Skin lesion   0/25 (0.00%)  0 1/27 (3.70%)  1 0/26 (0.00%)  0
Vascular disorders       
Hot flush   0/25 (0.00%)  0 1/27 (3.70%)  1 0/26 (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     History of Changes
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: May 1, 2019