PPI-Rebound-Trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-006731-45-DK

Enrollment

Unknown

Registered

2007-03-30

Start date

2007-04-26

Completion date

Unknown

Last updated

2017-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

This is a healthy volunteer trial designed to investigate if long-term treatment with nexium is the cause of a clinically significant acid rebound phenomenon. The intended indication for nexium is treatment of gastrooesophageal reflux disease, gastric and duodenal ulcers.

Interventions

Trade Name: Nexium Pharmaceutical Form: Tablet Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 18 years + 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: Dyspepsia within the preceeding 4 weeks Heartburn or acid regurgitation within the last 4 weeks Previous treatment with PPI or H2-blockers Previous contact to a doctor or hospital because of dyspepsia or reflux Previous abdominal surgery Use of NSAID, antacids, antidepressives and other analgesics on a regulary basis Potential language problems in understanding information and registering symp-toms Pregnancy or breast feeding Other diseases which can affect the symptom registration

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate the clinical relevance of the acid rebound phenomenon by comparing the occurence of refluxsymptoms in the actively treated group versus the placebogroup.;Secondary Objective: Analysis of the significance of helicobacter pylori infection. Comparison of the consumption of escape medication. Comparison of symptom scores in GSRS in week 9, 10, 11 and 12 in the active treated group versus the placebo group. Time to first reflux symptom defined as score > 1 in one of the questions or a to-tal score > 2 in the reflux part of GSRS. The impact of symptoms related to the acid rebound phenomena on QOL. The correlation between symptoms and s-gastrin and s-chromogranin A.;Primary end point(s): Comparison of the symptom scores in the reflux part of the GSRS in weeks 9,10,11 and 12 in the actively treated group versus the placebo group.	—

Measure

Time frame

Main Objective: To investigate the clinical relevance of the acid rebound phenomenon by comparing the occurence of refluxsymptoms in the actively treated group versus the placebogroup.;Secondary Objective: Analysis of the significance of helicobacter pylori infection. Comparison of the consumption of escape medication. Comparison of symptom scores in GSRS in week 9, 10, 11 and 12 in the active treated group versus the placebo group. Time to first reflux symptom defined as score > 1 in one of the questions or a to-tal score > 2 in the reflux part of GSRS. The impact of symptoms related to the acid rebound phenomena on QOL. The correlation between symptoms and s-gastrin and s-chromogranin A.;Primary end point(s): Comparison of the symptom scores in the reflux part of the GSRS in weeks 9,10,11 and 12 in the actively treated group versus the placebo group.

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Countries

Denmark

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026