Background
Disease background
Investigational product
Rationale
Objectives
Methods and design
Overall design
Number of patients and randomization
Study duration
Inclusion criteria and exclusion criteria
Terminations and withdrawals
Study treatment
Description of investigational product and the comparator product
Study drug administration
Packing and labeling
Handling and storage
Product accountability
Treatment compliance
Concomitant therapy
Supplemental analgesics
Study assessments and procedures (see Table 1)
Schedule of assessments
Period | Screening | Study period | ||||||
---|---|---|---|---|---|---|---|---|
Study day | −30 to −1 | −1 | 0 | 1 | 2 | 3–5 | 6 | Discharge |
Informed consent | X | |||||||
Medical history | X | |||||||
Demographic data | X | |||||||
Physical examination | X | X | ||||||
Vital signs | X | X | X | X | X | X | X | Xd |
Injection site evaluation | Xb | Xb | Xb | Xb | Xb | Xb | Xb,d | |
Laboratory tests | X | Xa | X | |||||
12-lead ECG/chest x-ray | X | |||||||
Inclusion/exclusion criteria | X | |||||||
Randomization | X | |||||||
Naldebain® administration | Xb | |||||||
Surgery | X | |||||||
Pain assessment | X | X | X | X | X | X | ||
BPI | X | X | X | |||||
Patient satisfaction | X | |||||||
Concomitant medication | X | X | X | X | X | X | X | Xd |
Adverse event record | X | X | X | X | X | X | Xd | |
Drug accountability for fentanyl | Xe | Xe | Xe | |||||
Discharge | Xc | |||||||
End of study | X |
Rating | Description |
---|---|
1 | Highly satisfied |
2 | Satisfied |
3 | Uncertain |
4 | Dissatisfied |
5 | Very dissatisfied |
Patient background
VAS and patient diary
Short-form BPI
Injection site evaluation (Table 3)
Grade | Definition |
---|---|
0 | No reaction |
1 | Burning/stinging or pain at the site of injection; no swelling or erythema present |
2 | Erythema at the site; no swelling present |
3 | Erythema and swelling present at the site; no treatment required |
4 | Erythema and swelling present; treatment required |
Adverse events
Severity | Description |
---|---|
Mild | Event may be noticeable to patient; does not influence daily activities; usually does not require intervention |
Moderate | Event may be of sufficient severity to make patient uncomfortable; performance of daily activities may be influenced; intervention may be required |
Severe | Event may cause severe discomfort; usually interferes with daily activities; patient may not be able to continue in the study; treatment or other intervention usually required |
Serious | Results in death or life-threatening situation; inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; or congenital anomaly/birth defect or important medical event |
Relationship | Description |
---|---|
Certain | An adverse event, including laboratory test abnormality, occurring in a plausible time relationship to drug administration, which cannot be explained by concurrent disease or other drugs or chemicals |
Probable/likely | An adverse event, including laboratory test abnormality, with a reasonable time sequence to administration of the drug that is unlikely to be attributed to a plausible response on withdrawal |
Possible | An adverse event, including laboratory test abnormality, with a reasonable time sequence to administration of the drug, which could also be explained by concurrent disease or other drugs or chemicals. Information on drug withdrawal may be lacking or unclear |
Unlikely | An adverse event, including laboratory test abnormality, with a temporal relationship to drug administration which makes a causal relationship improbable, in which other drugs, chemicals, or underlying disease provide plausible explanations |
Not related | An adverse event which is judged to be clearly due to extraneous causes (e.g., disease and environment) |