Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2025-12-24 @ 10:22 PM
NCT ID:
NCT01493635
Eligibility Criteria:
Inclusion Criteria:
* 18 years of age and over.
* Patient has a cancer diagnosis (based on radiological, histological, cytological, or operative evidence). Those with haematological malignancies are eligible.
* Cancer related pain - which in the opinion of the clinician is caused by the presence of tumour or metastases.
* Average pain score \> 4, on a numerical rating scale from 0-10, requiring step 2 analgesia (weak opioid).
* Patient is able to comply with trial procedures.
Exclusion Criteria:
* Patients who have received radiotherapy in the previous 6 weeks or are planned to receive radiotherapy during the trial period where in either case, it is expected to affect pain during the trial period.
* Pain due to surgery in the preceding 4 weeks.
* Life expectancy less than two months (based on clinical impression).
* Patients with psychotic disorders or cognitive impairment.
* Patients who have received regular doses (scheduled doses - NOT as required dosing) of weak or strong opioids in the preceding two weeks.
* Patients using immediate release opioids \> 2 doses/24 hours, in the previous 24 hours.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01493635
Study Brief:
Protocol Section:
NCT01493635