Efficacy Of Pregabalin In The Treatment Of Pancreatic Cancer Pain. A Randomized Controlled Double-Blind, Parallel Group Study
Conditions
Pancreatic Cancer.
Conditions: official terms
Pancreatic Neoplasms
Study Type
Interventional
Study Phase
Phase 4
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Intervention
Name: Placebo Type: Drug
Name: Pregabalin Type: Drug
Overall Status
Recruiting
Summary
This is a randomized, double blind controlled, parallel arms trial, aimed to assess the efficacy of pregabalin on pancreatic cancer induced abdominal pain. The goals of this study include (1) assessing the analgesic effect of pregabalin in comparison to placebo; assessing the presence of central sensitization and its potential reversion by Pregabalin; (3) assessing quality of life of patients treated with pregabalin in comparison to placebo; (4) to compare adverse effects in patients treated with Pregabalin in comparison to placebo; (5) to compare anxiety and depression in patients treated with pregabalin in comparison to placebo.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 64 Years
Minimum Age: 18 Years
Gender: Both
Criteria: 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.
Location
Hospital del Mar
Barcelona, Spain
Status: Recruiting
Contact: Dürsteler Christian, PhD - 0034 93 2483350 - cdursteler@parcdesalutmar.cat
Start Date
August 2012
Completion Date
December 2015
Sponsors
Parc de Salut Mar
Source
Parc de Salut Mar
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page