A study to compare whether there is a difference in the improvement of swallowing function between two types of anti-gastric ulcer drugs for elderly people with a history of gastric ulcer and dysphagia.

JRCT ID: jRCT1021230018

Registered date:29/07/2023

Basic Information

• Recruitment status: Pending

Health condition(s) or Problem(s) studied

Swallowing dysfunction
Gastric ulcer

• Date of first enrollment: 29/07/2023
• Target sample size: 88
• Study type: Interventional
• Intervention(s): Institutional elderly people aged 65 and over with a history of gastric ulcer who have dysphagia are divided into two groups, and each group received 150 mg/day of polaprezinc tablet or 300 mg/day of rebamipide tablet for two months. After that, the gastric ulcer therapeutic agents in both groups is exchanged, and the subjects are asked to take it again for two months.

Outcome(s)

• Primary Outcome: Improvement of swallowing reflex induction rate by taking a zinc-containing gastric ulcer drug or a non-zinc-containing gastric ulcer drug.

Secondary Outcome

1. Including cases that dropped out without performing 3 measurements of the simple swallowing provocation test, comparison of the amount of change in swallowing reflex induction time.
2.Comparison of the number of cases with improved swallowing reflex induction time.
3. Improvement of ADL and sarcopenia, gait status, score, and muscle mass.
4. Improvement of nutritional items in blood and biochemical tests.
5. Difference in increase in serum zinc concentration due to concomitant drugs, difference in the number of people who improved.
6. Difference in serum zinc concentration increase due to comorbidities, difference in the number of people who improved.
7. Changes in serum zinc concentration and substance P in blood and saliva.
8. Confirmation of the safety of administration of two gastric ulcer drugs to patients with dysphagia.

Key inclusion & exclusion criteria

• Age minimum: >= 65age old
• Age maximum: Not applicable
• Gender: Both
• Include criteria: Elderly people aged 65 years or older with a history of gastric ulcer who have subjective symptoms of swallowing dysfunction or who have been diagnosed with swallowing dysfunction, and who are taking antacids.

Exclude criteria

1.Difficult to take gastric ulcer drugs due to severe dementia or deterioration of consciousness.
2.Patients with a history of limb amputation near the wrist or ankle.
3.Continuously taking test drugs (polaprezinc, rebamipide) for more than 1 week within 2 weeks before informed consent.
4.Have been hospitalized for more than 1 week within 2 weeks before informed consent.
5.Patients who are judged to be unsuitable to participate in this study by the principal investigator or co-investigator.
6.Patients who are allergic to test drugs (polaprezinc, rebamipide) .
7.Patients who are judged to be difficult to participate in the study due to complication of psychosis or psychiatric symptoms.
8.Patients who are judged to be unable to perform the test due to severe dementia, etc.

Related Information

• Primary Sponsor: Seki Yumika