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

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ClinicalTrials.gov Identifier: NCT01265550
Recruitment Status : Completed
First Posted : December 23, 2010
Results First Posted : February 26, 2018
Last Update Posted : February 26, 2018
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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Medical Treatment Group

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.

Surgical Treatment Group Nissen fundoplication: laparoscopic antireflux surgery
Placebo Medical Treatment Group

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.


Participant Flow:   Overall Study
    Medical Treatment Group   Surgical Treatment Group   Placebo Medical Treatment Group
STARTED   25   27   26 
COMPLETED   10   19   6 
NOT COMPLETED   15   8   20 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Medical Treatment Group

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.

Surgical Treatment Group Nissen fundoplication: laparoscopic antireflux surgery
Placebo Medical Treatment Group

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 Total of all reporting groups

Baseline Measures
   Medical Treatment Group   Surgical Treatment Group   Placebo Medical Treatment Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 25   27   26   78 
Age 
[Units: Years]
Mean (Standard Deviation)
 43.9  (12.2)   44.9  (11.8)   47.2  (11.7)   45.4  (11.8) 
Sex: Female, Male 
[Units: Participants]
Count of 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) 
[Units: Participants]
Count of 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) 
[Units: Participants]
Count of 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% 


  Outcome Measures

1.  Primary:   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   [ Time Frame: 12 months ]

2.  Secondary:   Number of Successful Participants With Anxiety and/or Depression.   [ Time Frame: 12 months ]

3.  Secondary:   Number of Successful Participants With Functional Heartburn   [ Time Frame: 12 months ]

4.  Secondary:   Number of Successful Participants With Functional Chest Pain of Presumed Esophageal Origin   [ Time Frame: 12 months ]

5.  Secondary:   Number of Successful Participants With Functional Dysphagia   [ Time Frame: 12 months ]

6.  Secondary:   Number of Successful Participants With Globus   [ Time Frame: 12 months ]

7.  Secondary:   Number of Successful Participants With Belching Disorders   [ Time Frame: 12 months ]

8.  Secondary:   Number of Successful Participants With Chronic Idiopathic Nausea   [ Time Frame: 12 months ]

9.  Secondary:   Number of Successful Participants With Functional Vomiting   [ Time Frame: 12 months ]

10.  Secondary:   Number of Successful Participants With Cyclic Vomiting Syndrome   [ Time Frame: 12 months ]

11.  Secondary:   Number of Successful Participants With Irritable Bowel Syndrome   [ Time Frame: 12 months ]

12.  Secondary:   Number of Successful Participants With Functional Bloating   [ Time Frame: 12 months ]

13.  Secondary:   Number of Successful Participants With Functional Diarrhea   [ Time Frame: 12 months ]

14.  Secondary:   Number of Successful Participants With Unspecified Functional Bowel Disorder   [ Time Frame: 12 months ]

15.  Secondary:   Number of Successful Participants With Functional Gallbladder Disorder   [ Time Frame: 12 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Stuart Spechler
Organization: Dallas VA Medical Center
e-mail: sjspechler@aol.com



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: February 26, 2018