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Study on the effect of Naldemedine Tosilate by diet

Study on the effect of Naldemedine Tosilate by diet - Survey on the effect of Naldemedine Tosilate

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000029459
Enrollment
14
Registered
2017-10-10
Start date
2017-09-21
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

opioid-induced constipation

Interventions

Take Naldemedine Tosilate after breakfast for 1 week and wake up the next week Take Naldemedine Tosilate wake up for 1 week and after breakfast the next week

Sponsors

National Hospital Organization Takasaki General Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)OIC patients 1.1week SBM less than 3 times 2.one or more of the following items a)constipation with straining b)a feeling of incomplete evacuation c)Pain at defecation 2)Men and women of ages 20 to 75 years old 3)Performance status(0-2) 4)Patients taking Boiled rice as staple food. 5)A written agreement is provided.

Exclusion criteria

Exclusion criteria: 1.Performance status(3-4) 2.artificial anus 3.ileus of intestine 4.patients taking specific dietary form (for example,liquid diet,etc) 5.Having regular use of Itraconazole,Fluconazole, Rifampicin,Ciclosporin 6.Patients who do not obtain written consent 7.Patients judged inappropriate by the research director

Design outcomes

Primary

MeasureTime frame
Comparison of the change amount from the baseline of the number of SBM per week due to the difference in usage and the time from oral administration to the first SBM

Secondary

MeasureTime frame
1) Change amount of NRS score 2) Change in rescue usage 3) Survey of senses by questionnaire

Countries

Japan

Contacts

Public Contacttakamitsu kanai

Takasaki General Medical Center, National Hospital Organization Department of pharmaceutical services

t-kanai3352@takasaki-hosp.jp027-322-5901

Outcome results

None listed

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