Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Efficacy of lansoprazole versus placebo in treatment of dyspepsia symptoms in endoscopy negative patients: a randomised controlled clinical trial
Acronym
Study hypothesis
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
Greater Glasgow Health Board - The West Ethical Committee on 17/061997 (ref: 97/106(2) (AHT/JR))
Study design
Interventional double-blind randomised placebo controlled single centre study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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 names
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 trial start date
01/12/1997
Overall trial end date
30/01/2000
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
105
Participant exclusion criteria
1. Current use of non-steroidal anti-inflammatory drugs or other medication
2. Any recognised cause of upper GI symptoms
Recruitment start date
01/12/1997
Recruitment end date
30/01/2000
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Institute of Cardiovascular and Medical Sciences
Glasgow
G11 6NT
United Kingdom
Sponsor information
Organisation
University of Glasgow (UK)
Sponsor details
University Avenue
Glasgow
G12 8QQ
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Industry
Funder name
Wyeth Laboratories (UK) (ref: PV 214058)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Western Infirmary (UK) - Hospital Endowment Fund (ref: 1116/6)
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
Basic results (scientific)
Publication list
2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21159892
Publication citations
-
Results
Fletcher J, Derakhshan MH, Jones GR, Wirz AA, McColl KE, BMI is superior to symptoms in predicting response to proton pump inhibitor: randomised trial in patients with upper gastrointestinal symptoms and normal endoscopy., Gut, 2011, 60, 4, 442-448, doi: 10.1136/gut.2010.228064.