Condition category
Digestive System
Date applied
24/10/2006
Date assigned
24/04/2007
Last edited
24/04/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 PPI’s 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, Barrett’s 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

http://www.erasmusmc.nl/content/englishindex.htm

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

Publication citations

Additional files

Editorial Notes