Break ThroughCancer Pain
Conditions
Interventions
De veiligheid en bijwerkingen van Nasalfent verder te beoordelen bij gebruik
gedurende een langere periode
To evaluate the safety and the side effects of Nasalfent in long term usage
Sponsors
I3Research
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Subjects will be included in the study if they meet all of the following criteria: 1. Subjects who are able and willing to provide written informed consent. 2. Male or female subjects, 18 years of age and older. 3. If female, and of childbearing potential (not surgically sterile or
Exclusion criteria
Exclusion criteria: Subjects may be excluded from participating in the study if they meet any of the following criteria: 1. Subjects with an opioid or fentanyl intolerance. 2. Subjects with uncontrolled or rapidly escalating pain. 3. Subjects using intrathecal or epidural opioids. 4. Subjects whose condition is unstable or rapidly deteriorating that the effective dose found during the Open, Dose-Titration Phase is unlikely to remain so for the duration of the study. 5. Subjects with sleep apnea or active brain metastases with increased intracranial pressures. 6. Subjects with any respiratory or cardiac condition that, in the opinion of the investigator, may be worsened by opioids. 7. Subjects with any other medical condition that, in the judgment of the investigator, would confound the objectives of the study. 8. Subjects with a recent history of alcohol or substance abuse that would compromise data collection. 9. Subjects with a history of or current neurological or psychiatric impairment, or cognitive dysfunction that, in the opinion of the investigator, would compromise data collection. 10. Subjects with clinically significant renal and hepatic dysfunction test results at Screening outside the following limits: a. Serum creatinine must be =50 mL/min. b. Serum total bilirubin must be
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events. Objective nasal examination. Subjective nasal assessment. Withdrawal due to AEs. Physical examination, including vital signs. Laboratory assessments. Subject acceptability assessments. | — |
Countries
Netherlands
Outcome results
None listed