No registrations found.
ID
Source
Brief title
Health condition
Gastroesophageal reflux disease (GERD), hiatal hernia
Sponsors and support
Intervention
Outcome measures
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
Background summary
The 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.
Study objective
The 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.
Study design
The 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.
Intervention
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.
Meibergdreef 9
H. Beaumont
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 5668708
h.beaumont@amc.uva.nl
Meibergdreef 9
H. Beaumont
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 5668708
h.beaumont@amc.uva.nl
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 < 3 cm
5. Hiatus hernia > or = 3 cm
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
NTR-new | NL1340 |
NTR-old | NTR1401 |
Other | : MEC 06/183 |
ISRCTN | ISRCTN wordt niet meer aangevraagd |