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

ISRCTN	ISRCTN32863375
DOI	https://doi.org/10.1186/ISRCTN32863375
Protocol serial number	N/A
Sponsor	University of Glasgow (UK)
Funders	Wyeth Laboratories (UK) (ref: PV 214058), Western Infirmary (UK) - Hospital Endowment Fund (ref: 1116/6)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof Kenneth E.L. McColl
Scientific

Institute of Cardiovascular and Medical Sciences
44 Church Street
Glasgow
G11 6NT
United Kingdom

Primary study design	Interventional
Study design	Interventional double-blind randomised placebo controlled single centre study
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Efficacy of lansoprazole versus placebo in treatment of dyspepsia symptoms in endoscopy negative patients: a randomised controlled clinical trial
Study objectives	Proton pump inhibitor therapy is superior to placebo in treatment of symptoms of dyspeptic patients with normal endoscopy and negative for H. pylori.
Ethics approval(s)	Greater Glasgow Health Board - The West Ethical Committee on 17/061997 (ref: 97/106(2) (AHT/JR))
Health condition(s) or problem(s) studied	Dyspepsia, upper gastrointestinal tract disease
Intervention	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.
Intervention type	Drug
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Lansoprazole
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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.
Completion date	30/01/2000

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	105
Key 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
Key exclusion criteria	1. Current use of non-steroidal anti-inflammatory drugs or other medication 2. Any recognised cause of upper GI symptoms
Date of first enrolment	01/12/1997
Date of final enrolment	30/01/2000

Institute of Cardiovascular and Medical Sciences

Glasgow
G11 6NT
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/04/2011		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes