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

NCT01768988 | Terminated Phase 4

• 1 other identifier: PANPAIN/1
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Cancer; Visceral Pain

Outcome Measures

Primary Outcomes (1)

• Pain intensity (Visual Analogue Scale; VAS Score)

  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.

  From baseline to day 90.

Secondary Outcomes (4)

• Quality of life

  From baseline to day 90.

• Performance status

  From baseline until to day 90.

• Anxiety and depression

  From baseline to day 90.

• Neuropathic Pain

  From baseline to day 90.

Study Arms (2)

Group I

EXPERIMENTAL

Conventional analgesic treatment + pregabalin.

Drug: Pregabalin

Group II

PLACEBO COMPARATOR

Conventional analgesic treatment + placebo.

Drug: Placebo

Interventions

Placebo DRUG

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).

Group II

Pregabalin DRUG

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).

Group I

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \. Patients \> 18 years old recently diagnosed of pancreatic cancer (\<3 months).
• \. Personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the trial.
• \. Patients willing and able to comply with the scheduled visits, treatment plan, laboratory tests and other trial procedures.

You may not qualify if:

• \. Patients with evidence or history of medical or surgical disease of importance for this study as judged by investigator.
• \. Patients with previously diagnosed moderate to severe renal impairment. Those with a Clearance of Creatinine (CLcr) \< 60mL/min should be excluded.
• \. Patients treated with anticonvulsants during the previous 4 months.

Sponsors & Collaborators

• Parc de Salut Mar: lead

Study Sites (1)

Hospital del Mar

Barcelona, 08003, Spain

Location

MeSH Terms

Conditions

Pancreatic Neoplasms; Visceral Pain

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Nociceptive Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: January 14, 2013
• First Posted: January 16, 2013
• Study Start: August 1, 2012
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: October 6, 2017

Record last verified: 2017-10

Locations

ES (1)