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

ISRCTN	ISRCTN32863375
DOI	https://doi.org/10.1186/ISRCTN32863375
Secondary identifying numbers	N/A

Submission date: 07/09/2010
Registration date: 08/09/2010
Last edited: 21/06/2011

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Digestive System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Kenneth E.L. McColl
Scientific

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

Study information

Study design	Interventional double-blind randomised placebo controlled single centre study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient 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
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Lansoprazole
Primary outcome measure	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 outcome measures	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.
Overall study start date	01/12/1997
Completion date	30/01/2000

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	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

Locations

Countries of recruitment

Scotland
United Kingdom

Study participating centre

Institute of Cardiovascular and Medical Sciences

Glasgow
G11 6NT
United Kingdom

Sponsor information

University of Glasgow (UK)
University/education

University Avenue
Glasgow
G12 8QQ
Scotland
United Kingdom

Website	http://www.gla.ac.uk/
"ROR"	https://ror.org/00vtgdb53

Funders

Funder type

Industry

Wyeth Laboratories (UK) (ref: PV 214058)

No information available

Western Infirmary (UK) - Hospital Endowment Fund (ref: 1116/6)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

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