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

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ClinicalTrials.gov Identifier: NCT01768988
Recruitment Status : Terminated (Change of PI. Former PI changed from Research Center and Promoter obliged unexpectedly to change the PI.)
First Posted : January 16, 2013
Last Update Posted : October 6, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Visceral Pain Drug: Placebo Drug: Pregabalin Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy Of Pregabalin In The Treatment Of Pancreatic Cancer Pain. A Randomized Controlled Double-Blind, Parallel Group Study
Study Start Date : August 2012
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Pregabalin
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Group I
Conventional analgesic treatment + pregabalin.
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).
Placebo Comparator: Group II
Conventional analgesic treatment + placebo.
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).


Outcome Measures

Primary Outcome Measures :
  1. Pain intensity (Visual Analogue Scale; VAS Score) [ Time Frame: From baseline to day 90. ]
    Analgesic effect of pregabalin therapy in pancreatic cancer patients, assessed using a visual analogue scale (VAS), the Brief Pain Inventory (BPI) and Neuropathic Pain VAS score.


Secondary Outcome Measures :
  1. Quality of life [ Time Frame: From baseline to day 90. ]
    Changes in quality of life compared to baseline level using SF-36 (Short-Form Health Survey) quality of life questionnaire.

  2. Performance status [ Time Frame: From baseline until to day 90. ]
    Performance status (Karnofsky Performance Status Scale).

  3. Anxiety and depression [ Time Frame: From baseline to day 90. ]
    Anxiety and depression will be also assessed, using Hospital Anxiety and Depression Scale (HADS).

  4. Neuropathic Pain [ Time Frame: From baseline to day 90. ]
    Neuropathic pain participation will be measured by a neuropathic pain questionnaire (NPSI).


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01768988


Locations
Spain
Hospital del Mar
Barcelona, Spain, 08003
Sponsors and Collaborators
Parc de Salut Mar
More Information

Responsible Party: CDursteler, MD, PhD, Parc de Salut Mar
ClinicalTrials.gov Identifier: NCT01768988     History of Changes
Other Study ID Numbers: PANPAIN/1
First Posted: January 16, 2013    Key Record Dates
Last Update Posted: October 6, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
Pancreatic Neoplasms
Cancer Pain
Visceral Pain
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Nociceptive Pain
Pregabalin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs