Contact information
Type
Scientific
Primary contact
Dr P J F de Jonge
ORCID ID
Contact details
's-Gravendijkwal 230
Rotterdam
3015 CE
Netherlands
+31 (0)10 463 5528
p.dejonge@erasmusmc.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
PIP study
Study hypothesis
1. To determine subgroups of patients with gastro-oesophageal reflux symptoms according to endoscopy and pH monitoring
2. To evaluate the differences in the subgroups of patients with Gastro-oEsophageal Reflux Disease (GERD) symptoms in:
a. duration of Proton Pump Inhibitor (PPI) treatment (four versus eight weeks)
b. inflammatory reaction
c. prevalence of Helicobacter pylori
d. occurrence of symptoms
3. To evaluate treatment of GERD patients with PPIs for four or eight weeks in order to determine the effectiveness of the PPI treatment
4. To evaluate the effect of PPI treatment on:
a. symptom relief
b. inflammatory reaction in the oesophagus
Ethics approval
Approval received from the Medical Ethics Committee (Medisch Ethische Toetsings Commissie Erasmus MC) (ref: MEC-2005-141).
Study design
Randomised multicentre trial
Primary study design
Interventional
Secondary study design
Multi-centre
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Gastro-oesophageal reflux disease
Intervention
All patients will undergo a baseline endoscopy and follow up endoscopy with biopsies, then they all will undergo a wireless oesophageal 48 hour pH monitoring study, and finally these patients will be randomised to either four weeks or eight weeks of 20 mg once daily rabeprazole treatment.
Intervention type
Drug
Phase
Not Specified
Drug names
Rabeprazole
Primary outcome measures
Differences in the subgroups of patients with GERD symptoms in:
1. Duration of PPI treatment (four versus eight weeks)
2. Inflammatory reaction
3. Prevalence of H. pylori
4. Occurrence of symptoms
Secondary outcome measures
Effect of PPI treatment on:
1. Symptom relief
2. Inflammatory reaction in the oesophagus
Overall trial start date
01/10/2005
Overall trial end date
01/10/2008
Reason abandoned
Eligibility
Participant inclusion criteria
1. Aged 18 years or older
2. Symptoms of GERD as determined by the GERD-Health Related Quality of Life (HRQL) questionnaire (score more than or equal to 12)
3. Informed consent
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
415
Participant exclusion criteria
1. Aged under 18 years
2. Unable to fill out questionnaire
3. Previous history of upper Gastro-Intestinal (GI) tract cancer
4. Previous history of achalasia
5. Previous surgery to the oesophagus or stomach
6. Endoscopically demonstrated and histologically proven complicated reflux disease (ulcer, stricture, Barretts esophagus)
7. Coagulation disorder if uncorrected at the time of endoscopy
8. Use of warfarin or other anti-coagulant medication if uncorrected at the time of endoscopy
9. Liver cirrhosis
10. Pregnancy and lactation
11. Contraindications to the study medication
Recruitment start date
01/10/2005
Recruitment end date
01/10/2008
Locations
Countries of recruitment
Netherlands
Trial participating centre
's-Gravendijkwal 230
Rotterdam
3015 CE
Netherlands
Sponsor information
Organisation
Erasmus Medical Center (The Netherlands)
Sponsor details
University Medical Center Rotterdam
s-Gravendijkwal 230
Rotterdam
3015 CE
Netherlands
+31 (0)10 463 55 28
p.dejonge@erasmusmc.nl
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Industry
Funder name
Janssen & Cilag B.V. (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary