Trial Information
Efficacy Of Pregabalin In The Treatment Of Pancreatic Cancer Pain. A Randomized Controlled Double-Blind, Parallel Group Study
Inclusion Criteria:
- 1. Patients > 18 years old recently diagnosed of pancreatic cancer (<3 months).
- 2. Personally signed and dated informed consent document indicating that the patient
has been informed of all pertinent aspects of the trial.
- 3. Patients willing and able to comply with the scheduled visits, treatment plan,
laboratory tests and other trial procedures.
Exclusion Criteria:
- 1. Patients with evidence or history of medical or surgical disease of importance for
this study as judged by investigator.
- 2. Patients with previously diagnosed moderate to severe renal impairment. Those with
a Clearance of Creatinine (CLcr) < 60mL/min should be excluded.
- 3. Patients treated with anticonvulsants during the previous 4 months.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Outcome Measure:
Pregabalin Therapy
Outcome Description:
Analgesic effect of pregabalin therapy in pancreatic cancer patients, assessed using a visual analogue scale (VAS), the Brief Pain Inventory (BPI) and Neuropathic Pain Symptom Inventory (NPSI).
Outcome Time Frame:
From baseline to day 90.
Safety Issue:
Yes
Authority:
Spain: Spanish Agency of Medicines
Study ID:
PANPAIN/1
NCT ID:
NCT01768988
Start Date:
August 2012
Completion Date:
December 2015
Related Keywords:
- Pancreatic Cancer.
- Pancreatic Neoplasms