Opioid Induced Constipation
Conditions
Interventions
Dosage and administration method:
The start date of administration of tramadol and naldemedine is defined as Day 1, and naldemedine and tramadol will be administered to patients who are deemed eligibl
Sponsors
Matsuyama Yukihiro
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who meet all of the following criteria at the time of obtaining consent for Visit 1 will be included in this study. 1) Patients who can obtain written consent to participate in the study of their own free will 2) Patients who are 18 years of age or older at the time of obtaining consent for Visit 1 3) Patients with chronic pain who have been diagnosed with non-cancer pain and have been experiencing pain for more than 3 months 4) Patients who plan to start or continue treatment for chronic non-cancer pain with the initial dose (100 mg/day) indicated on the package insert for tramadol for 14 days or more 5) Patients who can take oral medications, food, and beverages 6) Patients who can be evaluated using a patient diary (only when the patient is able to evaluate themselves, proxy recording in the patient diary is permitted)
Exclusion criteria
Exclusion criteria: Patients who meet any of the following criteria will be excluded from this study. 1) Patients who have used opioid analgesics within one month prior to the date of consent for Visit 1 2) Patients who have taken naldemedine in the past as of the date of consent for Visit 1 3) Patients who are undergoing treatment for malignant tumors as of the date of consent for Visit 1 4) Patients who meet two or more of the following criteria (Rome IV diagnostic criteria) within one week prior to the date of consent for Visit 1 a. More than 25% of bowel movements have straining b. More than 25% of bowel movements have rabbit feces or hard stools (Bristol scale 1-2) c. More than 25% of bowel movements have a feeling of residual evacuation d. More than 25% of bowel movements have a feeling of rectal blockage or congestion e. More than 25% of bowel movements have been manually promoted to promote bowel movement (e.g., fecal disimpaction, pelvic floor compression) f.SBM less than 3 times a week 5) Patients who have used laxatives within 1 month prior to the date of consent acquisition for Visit 1 (Laxatives taken as needed less than twice a week, including over-the-counter drugs, are acceptable) 6) Patients who are hospitalized or scheduled for hospitalization or surgery during the observation period 7) Patients participating or scheduled to participate in clinical trials or other interventional studies 8) Patients who are unable to walk independently 9) Patients with contraindications listed in the package inserts for naldemedine and tramadol 10) Patients with significant gastrointestinal structural abnormalities (e.g., mechanical ileus), diseases affecting gastrointestinal transit (e.g., paralytic ileus, uncontrolled hyperthyroidism/hypothyroidism), irritable bowel syndrome, inflammatory bowel disease (e.g., ulcerative colitis, Crohn's disease), active diverticular disease, or pelvic disorders that cause constipation (e.g., uterine prolapse, rectal prolapse, uterine fibroids affecting defecation, etc.). Or, even if the above diseases are currently cured, patients who are judged by a doctor to have an effect on gastrointestinal function (e.g., difficulty in oral intake). 11) Patients who have undergone surgery or treatment (e.g., nerve block [excluding upper limbs and lower limbs below the knee]) that affects gastrointestinal function, or radiation therapy that affects gastrointestinal function within 60 days prior to the date of consent acquisition, or patients who are scheduled to undergo such treatment during the observation period. 12) Patients with an artificial anus. 13) Patients with a dysfunctional or suspected dysfunctional blood-brain barrier. 14) Patients with significant cardiovascular risk factors, such as coronary artery disease, myocardial infarction, or stroke. 15) Patients with significant respiratory, hepatic, or renal dysfunction. 16) Pregnant women or women who may be pregnant, and nursing mothers. 17) Patients for whom it is difficult to explain the contents of the study or obtain consent due to cognitive impairment or psychiatric illness. 18) Patients who are judged by the principal investigator (subinvestigator) to be inappropriate to participate in this study based on other concomitant therapies or medical findings.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence rate of OIC during the 14-day observation period (the proportion of study subjects who were diagnosed with OIC at least once according to the Rome IV diagnostic criteria during the 14-day observation period) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Incidence rate of each constipation symptom (Rome IV criteria) during the 7-day and the 14-day observation period (proportion of study subjects who met the Rome IV criteria during the 14-day observation period) 2) Number of SBMs every 7 days during the 7-day and the 14-day observation period 3) Number of CSBMs every 7 days during the 7-day and the 14-day observation period 4) Change in PAC-SYM from baseline (Visit 1) to the 14th day of observation 5) BFI on the 7th and 14th days of observation 6) Change in pain intensity score (NRS) from baseline on the 7th and 14th days of observation 7) Number of times rescue laxatives were used concomitantly during the 7-day and the 14-day observation period and proportion of study subjects who used rescue laxatives concomitantly | — |
Contacts
Public ContactTomohiro Banno
Hamamatsu University Hospital
Outcome results
None listed