opioid-induced constipation
Conditions
Interventions
Sponsors
Eligibility
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
| Measure | Time 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
| Measure | Time frame |
|---|---|
| 1) Change amount of NRS score 2) Change in rescue usage 3) Survey of senses by questionnaire | — |
Countries
Japan
Contacts
Takasaki General Medical Center, National Hospital Organization Department of pharmaceutical services