Unique ID issued by UMIN | UMIN000014595 |
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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 |
A Randomized, Double-Blind, Placebo-Controlled, Crossover Study of NSAID
for the control of Acid-Induced Heartburn Symptom in Healthy Volunteers
Effect of NSAID on heartburn
A Randomized, Double-Blind, Placebo-Controlled, Crossover Study of NSAID
for the control of Acid-Induced Heartburn Symptom in Healthy Volunteers
Effect of NSAID on heartburn
Japan |
Gastroesophageal Reflux Disease (GERD)
Gastroenterology |
Others
NO
To investigate whether NSAID suppressed acid-induced heartburn in healthy participants by inhibiting PGE2 overproduction in the esophagus
Efficacy
Exploratory
Pragmatic
Phase IV
Change in heartburn symptom score (APSS) during acid perfusion test
1. Change in the time to first sensation
2. Changes in other upper GI symptoms
3. Change in esophageal PGE2 levels
Interventional
Cross-over
Randomized
Individual
Double blind -all involved are blinded
Placebo
NO
NO
No need to know
2
Treatment
Medicine |
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
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
20 | years-old | <= |
45 | years-old | >= |
Male
1. Healthy male subjects
2. Sufficient informed consent is obtained
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.
12
1st name | |
Middle name | |
Last name | Hiroto Miwa |
Hyogo College of Medicine
Department of Internal Medicine Division of Gastroenterology
1-1, Mukogawa-cho Nishinomiya, Hyogo
0798-45-6665
miwa-sec@hyo-med.ac.jp
1st name | |
Middle name | |
Last name | Takashi Kondo |
Hyogo College of Medicine
Department of Internal Medicine Division of Gastroenterology
1-1, Mukogawa-cho Nishinomiya, Hyogo
0798-45-6662
kondou@hyo-med.ac.jp
Hyogo College of Medicine
none
Self funding
NO
兵庫医科大学病院
2014 | Year | 07 | Month | 18 | Day |
Unpublished
No longer recruiting
2012 | Year | 04 | Month | 20 | Day |
2012 | Year | 05 | Month | 16 | Day |
2014 | Year | 07 | Month | 18 | Day |
2014 | Year | 07 | Month | 18 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016981
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