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

PHASE3CompletedINTERVENTIONAL
Enrollment

366

Participants

Timeline

Start Date

August 13, 2012

Primary Completion Date

December 30, 2016

Study Completion Date

December 30, 2016

Conditions
GERD
Interventions
DEVICE

Nissen fundoplication

laparoscopic antireflux surgery

DRUG

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."

DRUG

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.

Trial Locations (15)

13210

Syracuse VA Medical Center, Syracuse, NY, Syracuse

21201

Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD, Baltimore

27705

Durham VA Medical Center, Durham, NC, Durham

28144

Salisbury W.G. (Bill) Hefner VA Medical Center, Salisbury, NC, Salisbury

35233

Birmingham VA Medical Center, Birmingham, AL, Birmingham

48105

VA Ann Arbor Healthcare System, Ann Arbor, MI, Ann Arbor

64128

Kansas City VA Medical Center, Kansas City, MO, Kansas City

75216

VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX, Dallas

77030

Michael E. DeBakey VA Medical Center, Houston, TX, Houston

85723

Southern Arizona VA Health Care System, Tucson, AZ, Tucson

90822

VA Long Beach Healthcare System, Long Beach, CA, Long Beach

92357

VA Loma Linda Healthcare System, Loma Linda, CA, Loma Linda

98108

VA Puget Sound Health Care System Seattle Division, Seattle, WA, Seattle

06516

VA Connecticut Healthcare System West Haven Campus, West Haven, CT, West Haven

02130

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA, Boston

All Listed Sponsors
lead

VA Office of Research and Development

FED

NCT01265550 - A Randomized Trial of Medical and Surgical Treatments for Patients With GERD Symptoms That Are Refractory to Proton Pump Inhibitors | Biotech Hunter | Biotech Hunter