Ignite Creation Date:
2024-05-06 @ 12:45 PM
Last Modification Date:
2024-10-26 @ 1:03 PM
Study NCT ID:
NCT03835442
Status:
COMPLETED
Last Update Posted:
2019-02-08
First Post:
2019-02-04
Brief Title:
A Placebo Controlled Trial With Baclofen for the Treatment of GERD Patients With Incomplete PPI Response
Sponsor:
Universitaire Ziekenhuizen KU Leuven
Organization:
Universitaire Ziekenhuizen KU Leuven
Study Overview
Official Title:
A Placebo Controlled Trial With Baclofen for the Treatment of GERD Patients With Incomplete PPI Response
Status:
COMPLETED
Status Verified Date:
2019-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Reflux acid and non-acid mainly occurs during transient LES relaxations TLESRs The gamma-aminobutyric acid GABA receptor type B agonist baclofen was shown to inhibit TLESRs thereby significantly decreasing acid reflux after a meal in healthy controls and in patients with GERD
The primary objective of this study is to assess the efficacy assessed by reflux symptom questionnaire and pH-impedance recordings of baclofen 10mg three times daily vs placebo in GERD patients with an incomplete response to PPI therapy
The secondary objective is to assess the predictive value of reflux assessment by pH-impedance recordings on the primary outcome
The primary objective of this study is to assess the efficacy assessed by reflux symptom questionnaire and pH-impedance recordings of baclofen 10mg three times daily vs placebo in GERD patients with an incomplete response to PPI therapy
The secondary objective is to assess the predictive value of reflux assessment by pH-impedance recordings on the primary outcome
Detailed Description:
This is a randomized parallel double-blind placebo-controlled out-patient single-center study Eligible subjects will be randomly assigned to receive either oral baclofen 10 mg or placebo tid for a period 4 weeks After 4 weeks all patients will be given the standard dose of baclofen 10 mg tid open label for another 4 weeks The bid PPI therapy will be continued for the entire study duration
Approximately 90 evaluable subjects with typical GERD symptoms heartburn andor regurgitation will participate in this study and will be randomized on a 11 basis 45 subjects each will be in the placebo and baclofen 10 mg three times daily group Subjects will be considered to have completed the study if they complete the week 4 visit
Medication will consist of identically-looking capsules of baclofen or placebo Patients will take 1 capsule containing 5 mg baclofen with meals tid for 7 days and then 1 capsule containing 10 mg baclofen with meals tid for the remaining 21 days
Prior to visit 1 all subjects included in the study will undergo a 24 hr pH-impedance study which was requested by the treating physician This investigation is part of the standard clinical work up and will not be part of the study protocol
Informed consent is to be signed and dated by the subject before any study related procedures are performed The date of each visit to the clinic and the date and time of the last dose of test article will be recorded
Throughout the study patients will be asked to complete daily a short questionnaire ReQuest for reflux symptoms
Approximately 90 evaluable subjects with typical GERD symptoms heartburn andor regurgitation will participate in this study and will be randomized on a 11 basis 45 subjects each will be in the placebo and baclofen 10 mg three times daily group Subjects will be considered to have completed the study if they complete the week 4 visit
Medication will consist of identically-looking capsules of baclofen or placebo Patients will take 1 capsule containing 5 mg baclofen with meals tid for 7 days and then 1 capsule containing 10 mg baclofen with meals tid for the remaining 21 days
Prior to visit 1 all subjects included in the study will undergo a 24 hr pH-impedance study which was requested by the treating physician This investigation is part of the standard clinical work up and will not be part of the study protocol
Informed consent is to be signed and dated by the subject before any study related procedures are performed The date of each visit to the clinic and the date and time of the last dose of test article will be recorded
Throughout the study patients will be asked to complete daily a short questionnaire ReQuest for reflux symptoms
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None