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


Phase 4
18 Years
64 Years
Open (Enrolling)
Both
Pancreatic Cancer.

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Pregabalin Therapy

Outcome Description:

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).

Outcome Time Frame:

From baseline to day 90.

Safety Issue:

Yes

Authority:

Spain: Spanish Agency of Medicines

Study ID:

PANPAIN/1

NCT ID:

NCT01768988

Start Date:

August 2012

Completion Date:

December 2015

Related Keywords:

  • Pancreatic Cancer.
  • Pancreatic Neoplasms

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