Efficacy Of Pregabalin In The Treatment Of Pancreatic Cancer Pain. A Randomized Controlled Double-Blind, Parallel Group Study (PANPAIN/1)

Parc de Salut Mar

Status and phase

Terminated

Phase 4

Conditions

Visceral Pain

Pancreatic Cancer

Treatments

Drug: Pregabalin

Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT01768988

PANPAIN/1

Details and patient eligibility

About

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.

Enrollment

20 patients

Sex

All

Ages

18 to 64 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

1. Patients > 18 years old recently diagnosed of pancreatic cancer (<3 months).
1. Personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the trial.
1. 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.
1. Patients with previously diagnosed moderate to severe renal impairment. Those with a Clearance of Creatinine (CLcr) < 60mL/min should be excluded.
1. Patients treated with anticonvulsants during the previous 4 months.