Patients who receive colonoscopy
Conditions
Interventions
investigational material(s)
Generic name etc : l-menthol
INN of investigational material : levo menthol
Therapeutic category code : 799 Agents for not mainly purpose of therapeutic, n.e.c.
Dosage and
Sponsors
Nihon Pharmaceutical Co., Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Patients who are between 20 and 85 years at the time of consent (2) Patients who need colonoscopy
Exclusion criteria
Exclusion criteria: (1) Patients with a history of abdominal surgical treatment (including the laparoscopic surgery) including the gynecology operation (2) Patients with contraindication to colonoscopy including the paralytic ileus (3) Patients with a history of shock or hypersensitivity to l-menthol or peppermint oil (mint oil) (4) Patient with contraindication to bowel cleansing preparation (5) Patient with contraindication to pain medicine and sedative medicine (6) Patient with contraindication to butylscopolamine bromide and glucagon (7) Patients on cancer treatment (chemotherapy or radiotherapy) (8) Patient with active inflammatory bowel disease or infectious enteritis (9) Patients who need sedative in colonoscopy (10) Patients who receives a therapeutic colonoscopy (11) Pregnant or lactating women, women of childbearing potential, or women who plan to become pregnant during the study (12) Patients who have received other investigational drugs within four months before consent or who are participating in other clinical studies (13) Patients otherwise ineligible for participation in the study in the investigator's or subinvestigator's opinion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy exploratory Proportion of No or Mild colonic spasm at the all sites of NPO-13 treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy exploratory Proportion of No or Mild colonic spasm at the each site of NPO-13 treatment | — |
Countries
Japan
Outcome results
None listed