臨床研究等提出・公開システム

Randomized crossover open-label trial to evaluate the swallowability of different formulations (conventional tablets, OD tablets, mini-tablets, and foam formulations) in patients with post-stroke dysphagia.

Study on the ease of swallowing various formulations (tablets and new forms) in patients with post-stroke swallowing difficulties.

Yamamoto Mariko

Department of Pharmacy, Chutoen General Medical Center

1-1 Shobugaike, Kakegawa, Shizuoka, 436-8555, Japan

mariko-y01@chutoen-hp.shizuoka.jp

Yamamoto Mariko

Department of Pharmacy, Chutoen General Medical Center

1-1 Shobugaike, Kakegawa, Shizuoka, 436-8555, Japan

+81-537-21-5555

mariko-y01@chutoen-hp.shizuoka.jp

Recruiting

May. 11, 2026

Interventional

randomized controlled trial

open(masking not used)

no treatment control/standard of care control

crossover assignment

other

1. Post-stroke patients evaluated by a speech-language-hearing therapist as having mild dysphagia.
2. Patients who are able to consume fluids or meals and are scheduled to undergo videoendoscopic evaluation of swallowing.
3. Patients with a Repetitive Saliva Swallowing Test (RSST) score of 1 to 3.
4. Patients with an HDSR score of 21 or higher, or those without a diagnosis of dementia prior to admission.
5. Patients who have provided written informed consent to participate in this study.
6. Patients for whom consent has been obtained from the attending physician of the primary department at the time of admission.

1. Patients who do not meet the criteria for starting oral intake set by the Japanese Society of Dysphagia Rehabilitation.
2. Patients with dementia.
3. Patients aged 80 years or older.
4. Patients with a PAS score of 5 or higher during routine examination (patients with decreased pharyngeal sensation).
5. Patients with an RSST score of 0, or 4 or more.
6. Patients with difficulty in oral transit due to limited tongue range of motion.
7. Patients for whom safe examination cannot be performed based on the Hyodo score during videoendoscopic evaluation of swallowing.
8. Patients with self-reported oral abnormalities such as stomatitis.
9. Patients with a history of allergy to the additives in the formulations.
10. Patients with communication difficulties.
11. Patients judged unable to safely undergo the study based on the results of the videoendoscopic evaluation of swallowing (e.g., those with nasal cavity abnormalities or severe body movements).
12. Patients judged inappropriate for study participation by the principal investigator, sub-investigators, or the attending physician of the primary department at the time of admission.

Both

Dysphagia following stroke

Patients will receive four types of formulations (conventional tablet, orally disintegrating tablet [ODT], mini-tablet, and foam formulation) one by one, placed on the back of the tongue using a spoon. The conventional tablet and mini-tablet will be taken with 3 mL of water. The ODT will be allowed to disintegrate in the oral cavity before being swallowed with 3 mL of water. The foam formulation will be taken without water. If the formulation cannot be swallowed in one attempt, up to two additional swallowing attempts will be allowed. If swallowing is unsuccessful after a total of three attempts, the formulation will be spat out or suctioned. Furthermore, videoendoscopic evaluation of swallowing will be performed for one of the four formulations to observe and record the swallowing process.

Stroke, Dysphagia

Formulation, Swallowability, Foam formulation

D020521, D003680

D26.255

Visual analogue scale (VAS) score for overall ease of swallowing

Number of swallowing attempts to ingest the formulation, Observation of the swallowing process using videoendoscopy

+81-537-21-5555

Mar. 09, 2026

none