NCT01768988

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

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Parc de Salut Mar · Academic / Other
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pancreatic Cancer
• Visceral Pain

Interventions

Type	Name	Description
DRUG	Placebo	Conventional treatment + placebo (during 90 days). Conventional treatment comprises a WHO step ladder approach and comprises in most cases: 1. Paracetamol 1g/8h 2. Weak opioid (tramadol at maximal doses of 400 mg/24h) 3. Strong opioid in substitution of weak opioid if not efficient (e. g. morphine, oxycodone, fentanyl patch, hidromorphone), at the needed doses to control pain (VAS \< 3).
DRUG	Pregabalin	Treatment during 90 days with conventional treatment + pregabalin. Pregabalin doses were reached until the maximal doses (300 mg/12h) depending on patient tolerability. An escalating dose scheme were desigened as follows, to avoid tolerability problems: Week 1 75-0-75 Week 2 75-0-150 Week 3 150-0-150 Week 4 150-0-300 Week 5 300-0-300 (until the end of study) Conventional treatment comprises a WHO step ladder approach and comprises in most cases: 1. Paracetamol 1g/8h 2. Weak opioid (tramadol at maximal doses of 400 mg/24h) 3. Strong opioid in substitution of weak opioid if not efficient (e. g. morphine, oxycodone, fentanyl patch, hidromorphone), at the needed doses to control pain (VAS \< 3).

Timeline

• Start date: 2012-08-01
• Primary completion: 2017-12-01
• Completion: 2017-12-01
• First posted: 2013-01-16
• Last updated: 2017-10-06

Locations

1 site across 1 country: Spain