Gastroesophageal reflux disease
Conditions
Interventions
Trade Name: lioresal
Pharmaceutical Form: Capsule*
INN or Proposed INN: BACLOFEN
CAS Number: 1134-47-0
Current Sponsor code: Baclofen2009
Other descriptive name: baclofen2009
Concentration unit: mg mi
Sponsors
UZleuven
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 18 to 75 years old. 2. History of GERD symptoms during PPI treatment, at least 3 times per week for 12 weeks. 3. Daily intake of PPI treatment 12 weeks prior to inclusion, with at least 8 weeks of b.i.d. therapy (2*20mg of omeprazole or equivalent). 4. Sexually active women of child bearing potential participating in the study must use a medically acceptable form of contraception. Medically acceptable forms of contraception include oral contraceptives, injectable or implantable methods, intrauterine devices, or properly used barrier contraception. 5. Subjects must be capable of understanding and be willing to provide signed and dated written voluntary informed consent before any protocol-specific screening procedures are performed. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Endoscopic signs of severe erosive esophagitis (= grade C, Los Angeles classification) on endoscopy performed during PPI treatment in the 6 months prior to screening. 2. Systemic diseases, known to affect esophageal motility. 3. Surgery in thorax or in the upper part of the abdomen. 4. Treatment with baclofen prior to the start of the study. 5. Regular use of medications such as: anticholinergics, tricycle antidepressants. 6. Significant neurological, respiratory, hepatic, renal, haematological, cardiovascular, metabolic or gastroinestinal cerebrovascular disease as judged by the investigator 7. Absence of PPI intake for at least 2 consecutive days in the 2 weeks prior to the screening. 8. Pregnancy or breast feeding. 9. History of poor compliance. History of/or current psychiatric illness that would interfere with ability to comply with protocol requirements or give informed consent. (well-compensated depression is allowed). 10. History of alcohol or drug abuse that would interfere with ability to comply with protocol requirements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The Primary objective of this study is to assess the efficacy (assessed by reflux symptom questionnaire and pH-impedance recordings) of baclofen (lioresal®) 10mg three times daily vs. placebo in GERD patients with an incomplete response to PPI therapy.;Secondary Objective: The secondary objective is to assess the predictive value of reflux assessment (by pH-impedance recordings) on the primary outcome.;Primary end point(s): The primary efficacy endpoint will be symptom severity assessed by a validated reflux questionnaire (ReQuest). The secondary efficacy endpoint will be improvement of reflux parameters on 24hr impedance-pH recordings. | — |
Countries
Belgium
Outcome results
None listed