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

- candidate number3818
- NTR NumberNTR1401
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR10-aug-2008
- Secondary IDsMEC 06/183  
- Public TitleDoes the presence of a hiatal hernia affects the efficacy of the reflux inhibitor baclofen?
- Scientific TitleDoes the presence of a hiatal hernia affects the efficacy of the reflux inhibitor baclofen?
- hypothesisThe efficacy of reflux inhibitors, which block transient lower esophageal sphincter relaxations (TLESRs), to reduce acid and non-acid exposure may be hampered in the presence of a hiatal hernia, as other mechanisms of reflux become more important.
- Healt Condition(s) or Problem(s) studiedGastroesophageal reflux Disease (GERD), Baclofen, Hiatal hernia
- Inclusion criteria1. 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 < 3 cm
5. Hiatus hernia > or = 3 cm
- Exclusion criteria1. 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
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mrt-2007
- planned closingdate1-mrt-2008
- Target number of participants30
- InterventionsTwice 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.
- Primary outcome- The number of reflux episodes (acid and non acid) measured over 24 hours
- Secondary outcome- Total acid exposure time, the composition of the refluxate and the proximal extent of the refluxate
- TimepointsThe ambulatory impedance/ pH metry will be performed twice, at day 11 after the start of baclofen / placebo and with at least a 7 days wash out period between both study periods.
- Trial web siteN/A
- statusstopped: trial finished
- Sponsor/Initiator Academic Medical Center (AMC), Department of Hepato- and Gastroenterology
- Funding
(Source(s) of Monetary or Material Support)
AstraZeneca R&D Mölndal, Sweden
- PublicationsN/A
- Brief summaryThe presence of a hiatal hernia may hamper the efficacy of anti-TLESR therapy in the treatment of gastroesophageal reflux disease (GERD) as other mechanisms for reflux to occur become more important. Therefore, a randomized, placebo controlled double blind crossover studywill be performed, whereby the effect of baclofen on the rate of reflux episodes will be evaluated in GERD patient with (¡Ý 3cm) and without hiatal hernia. Patients will undergo twice a combined ambulatory 24 hours impedance pH metry measurement while on PPI¡¯s and 3x20mg baclofen or placebo. Acid and non-acid reflux rate, acid exposure time and acid clearance will be analysed for both studydays and compared between both patientgroups.
- Main changes (audit trail)
- RECORD10-aug-2008 - 22-aug-2008

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