Opioid-induced constipation
Conditions
Interventions
Sponsors
Hainan General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Patients aged 18 years or older at the time of informed consent and provide written informed consent; 2. Men and women, be willing and suitable to receive inpatient hospitalization or outpatient treatment in the hospital located in Boao-Lecheng international medical tourism pilot zone; 3. Patients with histologically or cytologically confirmed neoplasm causing pain and receiving opioids treatment; 4. Patients who must have been treated with a stable opioid regimen for at least 7 days prior to the first administration of IMP and received daily opioid treatment >= 80% of the screen period; 5. Patients should be diagnosed with OIC with the frequency of SBMs = 20 weeks; 7. Patients can clearly communicate with HCP about the pain and OIC status and record them; 8. Patients agree to use an appropriate method of contraception (use of a condom and consideration of contraception for partner) if they or their partners are able to become pregnant, from the first day of taking the IMP and to up to 7 days after the last dose of the IMP; 9. Patients who are able to understand and are willing to sign an informed consent form prior to the screening period and comply with all study procedures and requirements.
Exclusion criteria
Exclusion criteria: 1. Patients who have evidence of significant structural abnormalities of the GI tract (such as mechanical ileus), active medical diseases affecting bowel transit (such as paralytic ileus, peritoneal metastasis or peritoneal cancer affecting GI function, uncontrolled hyperthyroidism or hypothyroidism), irritable bowel syndrome (IBS), inflammatory bowel disease (such as ulcerative colitis, Crohn's disease), or active diverticular disease, a pelvic disorder which causes constipation (such as uterine prolapse, rectal prolapse, and uterine fibroids affecting bowel movement), or these diseases which are considered to have obvious effects on the GI functions by the investigator/sub-investigator even if these diseases have recovered now; 2. Patients who are pregnant or lactating women, or who expect own pregnancy or partners pregnancy during the study period; 3. Patients who have evidence of ileus within 1 year prior to the informed consent obtained; 4. Patients with no function of the blood-brain barrier or suspected dysfunction, such as patients with brain tumors, including patients with metastatic tumors; 5. Patients who are known or suspected to have hypersensitivity to Naldemedine, naltrexone, methylnaltrexone, naloxone, or any other opioid antagonist; 6. Other patients who will be considered ineligible for the study by the investigator/sub-investigator on the basis of concomitant therapy and medical findings.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Spontaneous bowel movements (SBM) responders during the first 2 weeks; | — |
Secondary
| Measure | Time frame |
|---|---|
| The safety of Naldemedine;Proportion of subjects with CSBM (Complete Spontaneous Bowel Movement) responders during the first 2 weeks of the Treatment Period.;Proportion of subjects with SBM/CSBM responder for each week during the first 2 weeks of the Treatment Period;Change in the frequency of SBMs/CSBMs per week from baseline during the first 2 weeks of Treatment Period.;Time to the first SBM/CSBM after the first administration of IMP.;Proportion of subjects with at least 1 SBM/CSBM for each observation period within 24 hours after the first administration of IMP.;Change in Patient Assessment of Constipation Symptoms (PAC-SYM) and Patient Assessment of Constipation Quality of Life (PAC-QOL) from baseline to each observation time point.; | — |
Countries
China
Contacts
Public ContactWang Lin
Hainan General Hospital
Outcome results
None listed