Efficacy Of Pregabalin In The Treatment Of Pancreatic Cancer Pain. A Randomized Controlled Double-Blind, Parallel Group Study
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Efficacy Of Pregabalin In The Treatment Of Pancreatic Cancer Pain. A Randomized Controlled Double-Blind, Parallel Group Study|
- Pregabalin Therapy [ Time Frame: From baseline to day 90. ] [ Designated as safety issue: Yes ]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).
- Quality of life [ Time Frame: From baseline to day 90. ] [ Designated as safety issue: Yes ]Changes in quality of life compared to baseline level using SF-12 (Short-Form Health Survey) quality of life questionnaire.
- Performance status [ Time Frame: From baseline until to day 90. ] [ Designated as safety issue: Yes ]Performance status (Karnofsky Performance Status Scale).
- Anxiety and depression [ Time Frame: From baseline to day 90. ] [ Designated as safety issue: Yes ]Anxiety and depression will be also assessed, using Hospital Anxiety and Depression Scale (HADS).
|Study Start Date:||August 2012|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||August 2015 (Final data collection date for primary outcome measure)|
Experimental: Group I
Conventional analgesic treatment + pregabalin.
Treatment during 90 days with pregabalin.
Placebo Comparator: Group II
Conventional analgesic treatment + placebo.
|Contact: Dürsteler Christian, PhD||0034 93 firstname.lastname@example.org|
|Hospital del Mar||Recruiting|
|Barcelona, Spain, 08003|
|Contact: Dürsteler Christian, PhD 0034 93 2483350 email@example.com|