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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000014595
Receipt No. R000016981
Scientific Title A Randomized, Double-Blind, Placebo-Controlled, Crossover Study of NSAID for the control of Acid-Induced Heartburn Symptom in Healthy Volunteers
Date of disclosure of the study information 2014/07/18
Last modified on 2014/07/18

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Basic information
Public title A Randomized, Double-Blind, Placebo-Controlled, Crossover Study of NSAID
for the control of Acid-Induced Heartburn Symptom in Healthy Volunteers
Acronym Effect of NSAID on heartburn
Scientific Title A Randomized, Double-Blind, Placebo-Controlled, Crossover Study of NSAID
for the control of Acid-Induced Heartburn Symptom in Healthy Volunteers
Scientific Title:Acronym Effect of NSAID on heartburn
Region
Japan

Condition
Condition Gastroesophageal Reflux Disease (GERD)
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate whether NSAID suppressed acid-induced heartburn in healthy participants by inhibiting PGE2 overproduction in the esophagus
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes Change in heartburn symptom score (APSS) during acid perfusion test
Key secondary outcomes 1. Change in the time to first sensation
2. Changes in other upper GI symptoms
3. Change in esophageal PGE2 levels

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Diclofenac sodium is given at 6 h and 2 h before the acid perfusion test -> Placebo is given at 6 h and 2 h before the acid perfusion test
Interventions/Control_2 Placebo is given at 6 h and 2 h before the acid perfusion test -> Diclofenac sodium is given at 6 h and 2 h before the acid perfusion test
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
45 years-old >=
Gender Male
Key inclusion criteria 1. Healthy male subjects
2. Sufficient informed consent is obtained
Key exclusion criteria 1. Subjects who undergo upper gastrointestinal endoscopy and are found to have significant organic diseases (e.g., esophagitis, Barrett's esophagus, hiatus hernia, active peptic ulcer disease, and esophageal/gastric cancer)
2. Subjects with medical history of asthma or allergy to NSAIDs
3. Subjects with history of peptic ulcer or GERD or of upper GI tract surgery
4. Subjects with significant cardiovascular, kidney, liver, neurotic, or psychological disorders
5. Subjects with FSSG total score of >8
6. Subjects taking medications that may affect prostaglandin generation, including NSAIDs, COX-2 inhibitors, or prostaglandin-containing medications
7. Individuals judged by investigators as ineligible for study enrollment.
Target sample size 12

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Hiroto Miwa
Organization Hyogo College of Medicine
Division name Department of Internal Medicine Division of Gastroenterology
Zip code
Address 1-1, Mukogawa-cho Nishinomiya, Hyogo
TEL 0798-45-6665
Email miwa-sec@hyo-med.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Takashi Kondo
Organization Hyogo College of Medicine
Division name Department of Internal Medicine Division of Gastroenterology
Zip code
Address 1-1, Mukogawa-cho Nishinomiya, Hyogo
TEL 0798-45-6662
Homepage URL
Email kondou@hyo-med.ac.jp

Sponsor
Institute Hyogo College of Medicine
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 兵庫医科大学病院

Other administrative information
Date of disclosure of the study information
2014 Year 07 Month 18 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2012 Year 04 Month 20 Day
Date of IRB
Anticipated trial start date
2012 Year 05 Month 16 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 07 Month 18 Day
Last modified on
2014 Year 07 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016981

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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