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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Parc de Salut Mar
Sponsor:
Information provided by (Responsible Party):
Parc de Salut Mar
ClinicalTrials.gov Identifier:
NCT01768988
First received: January 14, 2013
Last updated: January 15, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Pancreatic Cancer.
Drug: Placebo
Drug: Pregabalin
Phase 4

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Parc de Salut Mar:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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).


Estimated Enrollment: 72
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)
Arms Assigned Interventions
Experimental: Group I
Conventional analgesic treatment + pregabalin.
Drug: Pregabalin
Treatment during 90 days with pregabalin.
Placebo Comparator: Group II
Conventional analgesic treatment + placebo.
Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01768988

Contacts
Contact: Dürsteler Christian, PhD 0034 93 2483350 cdursteler@parcdesalutmar.cat

Locations
Spain
Hospital del Mar Recruiting
Barcelona, Spain, 08003
Contact: Dürsteler Christian, PhD    0034 93 2483350    cdursteler@parcdesalutmar.cat   
Sponsors and Collaborators
Parc de Salut Mar
  More Information

No publications provided

Responsible Party: Parc de Salut Mar
ClinicalTrials.gov Identifier: NCT01768988     History of Changes
Other Study ID Numbers: PANPAIN/1
Study First Received: January 14, 2013
Last Updated: January 15, 2013
Health Authority: Spain: Spanish Agency of Medicines

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Pregabalin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on September 30, 2014