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

NCT ID: NCT01768988

Last Updated: 2017-10-06

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2017-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group I

Conventional analgesic treatment + pregabalin.

Group Type: EXPERIMENTAL

Pregabalin

Intervention Type: 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 II

Conventional analgesic treatment + placebo.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: 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).

Interventions

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).

Intervention Type: 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).

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Parc de Salut Mar

OTHER

Sponsor Role: lead

Responsible Party

CDursteler

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hospital del Mar

Barcelona, , Spain

Countries

Spain

Other Identifiers

PANPAIN/1

Identifier Type: -

Identifier Source: org_study_id