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Symptomatic response to proton pump inhibitor (PPI) in patients with non-ulcer dyspepsia

Efficacy of lansoprazole versus placebo in treatment of dyspepsia symptoms in endoscopy negative patients: a randomised controlled clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN32863375
Enrollment
105
Registered
2010-09-08
Start date
1997-12-01
Completion date
Unknown
Last updated
2015-01-13

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

Conditions

Dyspepsia, upper gastrointestinal tract disease Digestive System Dyspepsia

Interventions

Active: Lansoprazole 30 mg per day, once per day, per oral, for 14 days. Follow up for 14 days. Control: Placebo, once per day, per oral, for 14 days. Follow up for 14 days.

Sponsors

University of Glasgow (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Upper gastrointestinal (GI) symptoms of more than 3 months duration 2. No evidence of peptic ulcer disease, erosive oesophagitis or hiatus hernia in endoscopy 3. H. pylori negative on histology and urease test 4. Aged 24 - 72 years, either sex

Exclusion criteria

Exclusion criteria: 1. Current use of non-steroidal anti-inflammatory drugs or other medication 2. Any recognised cause of upper GI symptoms

Design outcomes

Primary

MeasureTime frame
Change in overall symptom score measured by modified Glasgow Dyspepsia Severity Score. All these measurements will be taken on baseline and at the end of 2 weeks.

Secondary

MeasureTime frame
Predictors of response to lansoprazole including symptom severity score, symptom characteristics, oesophageal 24h pH metry and oesophageal manometry profiles and body mass index (BMI). All these measurements will be taken on baseline.

Countries

United Kingdom

Outcome results

None listed

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