UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014595 |
|---|---|
| Receipt number | 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 22:51:58 |
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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
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
miwa-sec@hyo-med.ac.jp
Public contact
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
kondou@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo College of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016981
