Effect of sustained release baclofen on alleviation of gastro-esophageal reflux disease symptoms

Effect of Baclofen sustained release vs placebo on alleviation of reflux symptoms in patients with Gastroesophageal reflux disease

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12613000910707

Enrollment

Registered

2013-08-15

Start date

2013-06-14

Completion date

2014-01-10

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Proton Pump Inhibitors(PPIs) such as omeprazole are primary treatment for gastroesophageal reflux disease(GERD). Some patients do not cure adequetly with using PPIs. So we want to try effect of addition baclofen sustained release 10 mg twice daily vs placebo in addition to omeprazole 20 mg/d in both groups in alleviation of gastroesophageal reflux symptoms.

Interventions

Addition of oral tablet baclofen sustained release 10 mg twice daily or placebo twice daily for 1 months to the selective treatment of Gastroesophageal reflux disease in Iranian clinics(oral omeprazole 20 mg/d for 2 months). Baclofen/placebo and omeprazole will be start at the same time. Adherence monitoring by pill count

Study design

Allocation

Randomised controlled trial

Primary purpose

Treatment

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Healthy volunteers

Inclusion criteria

patients with diagnosis of Gastroesophageal reflux disease on the basis of Rome 3 criteria

Exclusion criteria

1.history of Hypersensivity to baclofen 2.renal or hepatic failure 3.Neurological diseases 4.pregnant women 5.breastfeeding women

Outcome results