EUCTR2009-017351-96-BE
Active, Not Recruiting
N/A
A placebo controlled trial with Baclofen for the treatment of GERD patients with incomplete PPI response
Zleuven0 sitesDecember 3, 2009
ConditionsGastroesophageal reflux disease
Drugslioresal
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Gastroesophageal reflux disease
- Sponsor
- Zleuven
- Status
- Active, Not Recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
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.
Outcomes
Primary Outcomes
Not specified
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