Effectiveness of therapy with acotinamide hydrochloride and Trimebutine Maleateon gastro-oesophagial disease in systemic sclerosis

Effectiveness of therapy with acotinamide hydrochloride and Trimebutine Maleateon gastro-oesophagial disease in systemic sclerosis - Therapy with acotinamide hydrochloride and Trimebutine Maleateon gastro-oesophagial disease in SSC

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000026859

Enrollment

Registered

2017-04-05

Start date

2017-04-10

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

systemic sclerosis

Interventions

acotinamaide hydrpchloride 100 mg tablets, 3 times/day, 28 days trimebutine maleateon 100 mg tablets, 3 times/day, 28 days

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: The patients with systemic sclerosis (both lc-SSc and dc-SSc) who have symptoms esophgial dysfunction. The patients satisfied the SSc criteria 2007 by the Specified Disease Treatment Research Program based on the Health Service Bureau of the Ministry of Health, Labour and Welfare.

Exclusion criteria

Exclusion criteria: 1) the patients who have taken proton pomp inhibitor or vonoprazan within 2 months. 2) the patients who have sensitivity against acotinamide hydrochloride or trimebutine maleateon

Design outcomes

Primary

Measure	Time frame
tally a questionnaire survey; general assessment of the degree of improvement or deterioration of gastro-esophageal symptom at 4W and 8W	—

Secondary

Measure	Time frame
assessment of each question in a questionnaire.	—

Countries

Japan

Contacts

Public ContactMayuko Moriyama

Shimane University Hospital Department of Rheumatology

mmayuko@med.shimane-u.ac.jp0853-20-2197

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026