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Does the presence of a hiatal hernia affects the efficacy of the reflux inhibitor baclofen?

Does the presence of a hiatal hernia affects the efficacy of the reflux inhibitor baclofen?

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON23260
Enrollment
30
Registered
2008-08-10
Start date
2007-03-01
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Gastroesophageal reflux disease (GERD), hiatal hernia

Interventions

Twice a 24 hours ambulatory combined impedance measurement and pH metry (transnasally). A dose of 3x20mg baclofen and a dose of 3xplacebo
the initial dose consisted of 3 x 5 mg baclofen. Every fourth day, the dose was increased by 5 mg three times daily until a dose of 20 mg three times daily was reached after 10 days.

Sponsors

Academic Medical Center (AMC), Department of Gastroenterology and Hepatology
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. GERD patients (M/F) with typical heartburn symptoms at least 3 times weekly during the last 3months 2. Daily use of PPIs 3. 18-70 years 4. Hiatal hernia or = 3 cm

Exclusion criteria

Exclusion criteria: 1. Thoracal or upper abdominal surgery 2. Use of drugs which influence gastrointestinal motility 3. Systemical illness which influence esophageal motility 4. Epilepsy 5. Renal function disorder 6. Pregnancy

Design outcomes

Secondary

MeasureTime frame
- Total acid exposure time, the composition of the refluxate and the proximal extent of the refluxate

Primary

MeasureTime frame
- The number of reflux episodes (acid and non acid) measured over 24 hours

Contacts

Public ContactH. Beaumont

Academic Medical Center Meibergdreef 9

h.beaumont@amc.uva.nl+31 (0)20 5668708

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)