臨床研究等提出・公開システム

Date of registration	April. 28, 2026
Last modified on	Sept. 02, 2026
Trial ID	jRCT2031260060

Scientific Title	A Phase 2, randomized, double-blind, placebo-controlled, parallel-group study of naldemedine in adult participants with constipation associated with Parkinson's disease
Public Title	A Phase 2 study of naldemedine in participants with constipation associated with Parkinson's disease

Contact for Scientific Queries	Name	Gomez - Juan Carlos
	Affiliation	Shionogi & Co., Ltd.
	Address	1-8, Doshomachi 3-chome, Chuo-ku, Osaka, Osaka
	Telephone	+81-6-6209-7885
	E-mail	shionogiclintrials-admin@shionogi.co.jp
Contact for Public Queries	Name	Corporate Communications Department - -
	Affiliation	Shionogi & Co., Ltd.
	Address	GRAND GREEN OSAKA South Building Park Tower, 5-54 Ofuka-cho, Kita-ku, Osaka, Osaka
	Telephone	+81-6-6209-7885
	E-mail	shionogiclintrials-admin@shionogi.co.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		May. 01, 2026
Actual date of first enrollment		May. 15, 2026
Target sample size		40
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	double blind
	control	placebo control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	Patients aged 18 to under 80 at the time of obtaining the informed consent form (ICF). Patients diagnosed with Parkinson's disease with a Hoehn-Yahr severity classification of grade 1 to 3. Patients with no significant changes in bowel movements (frequency, etc.) during the 3 months prior to obtaining informed consent, and who rarely experience diarrhea unrelated to laxative use. Patients who experienced 5 or fewer spontaneous bowel movements (SBM ; a bowel movement without the use of a rescue laxative within the previous 24 hours) in the 2 weeks prior to the start of investigational drug administration, and who experienced straining, a feeling of incomplete evacuation, hard stools, or rabbit-pellet-like stools in 25% or more of their bowel movements during that period.
	Exclusion Criteria	Patients whose primary cause of constipation is determined by the principal investigator (or co-investigator) to be other than Parkinson's disease. Patients who have not had a bowel movement in the week prior to obtaining informed consent or in the week prior to the start of investigational drug administration. Patients with gastrointestinal obstruction or suspected gastrointestinal obstruction, or patients with a history of gastrointestinal obstruction and a high risk of recurrence. Patients whose Parkinson's disease treatment has been changed within the 4 weeks prior to obtaining informed consent.
	Age Minimum	18age old over
	Age Maximum	80age old not
	Gender	Both
Health Condition(s) or Problem(s) Studied		Constipation associated with Parkinson's disease
Intervention(s)		Oral administration of naldemedine or placebo
Primary Outcome(s)		Change from baseline in the number of SBMs within 24 hours after the first administration.

Primary Sponsor	Shionogi & Co., Ltd.

Name of Certified Review Board	IRB of Nishiniigata Chuo Hospital
Address	1-14-1 Masago, Nishi-ku, Niigata-shi, Niigata
Telephone	+81-25-265-3171
E-Mail	224-Trial-question@mail.hosp.go.jp
Approval Status	Approval
Date of approval	April. 09, 2026

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
2	Sept. 02, 2026	(this page)	Changes
1	April. 28, 2026	Detail

List of change history