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Neuropathic Pain | Effect of Pregabalin in Patients With Radiotherapy-related Neuropathic Pain

Neuropathic Pain research study

What is the primary objective of this study?

Rationale: Pregabalin is effective on radiotherapy-related neuropathic pain. Purpose: This randomized, double-blind, placebo-controlled trial aims to investigate the effect and safety of pregabalin in treating radiotherapy-related neuropathic pain.

Who is eligible to participate?

Inclusion Criteria: 1. Patients must have received radiation therapy for histologically confirmed head and neck cancer. 2. Clinical evidence support the diagnosis of radiation-related neuropathic pain (confirmed by the Michigan Neuropathy Screening Instrument) and had a daily pain score of 4 or higher based on a numerical rating scale (0-10 points). 3. Neuropathic pain defined according to clinical history, symptoms, physical signs, and a score>= 12 in Chinese version of Leeds Assessment of Neuropathic Symptoms and Signs questionnaire by two neurology specialists. 4. The mean duration of pain is more than 4 weeks. 5. Fertile women who are willing to take contraception during the trial. 6. Routine laboratory studies with bilirubin </=2 * upper limits of normal (ULN), aspartate aminotransferase (AST or SGOT) < 2 * ULN, creatinine <1.0 * ULN, red-cell count >/= 4,000 per cubic millimeter; white-cell count >/=1500 per cubic millimeter, platelets >/= 75,000 per cubic millimeter; Hb >/=9.0. 7. Ability to understand and willingness to sign a written informed consent document. Exclusion Criteria: 1. Current diagnosis of tumor recurrence or metastasis and evidence of tumor associated pain. 2. Evidence of secondary neuropathic pain other than radiation. 3. Treatment with carbamazepine, gabapentin or pregabalin within 30 days before study enrollment. 4. Ongoing treatment for neuropathic pain. 5. History of anaphylactic response to pregabalin. 6. Evidence of sever systematic diseases.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Neuropathic Pain

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:PregabalinAt the 4-week dose-titration phase, will receive one capsule of pregabalin (75 mg) twice daily from Day 1 to Day 7, and two capsules of pregabalin (150 mg) twice daily from Day 8 to Day 14. From Day 15 to Day 28, patients will perform dosage adjustments based on the pain relief and tolerability. At maintenance phase, patients will take the optimized dosage of pregabalin.

Drug:PlaceboAt the 4-week dose-titration phase, will receive one capsule of placebo twice daily from Day 1 to Day 7, and two capsules of placebo twice daily from Day 8 to Day 14. From Day 15 to Day 28, patients will perform dosage adjustments based on the pain relief and tolerability. At maintenance phase, patients will take the optimized dosage of placebo.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

PregabalinArm I:At the 4-week dose-titration phase, will receive one capsule of pregabalin (75 mg) twice daily from Day 1 to Day 7, and two capsules of pregabalin (150 mg) twice daily from Day 8 to Day 14. From Day 15 to Day 28, patients will perform dosage adjustments based on the pain relief and tolerability. At maintenance phase, patients will take the optimized dosage of pregabalin.

PlaceboArm II:At the 4-week dose-titration phase, will receive one capsule of placebo twice daily from Day 1 to Day 7, and two capsules of placebo twice daily from Day 8 to Day 14. From Day 15 to Day 28, patients will perform dosage adjustments based on the pain relief and tolerability. At maintenance phase, patients will take the optimized dosage of placebo.

Study Status

Completed

Start Date: February 2013

Completed Date: January 2017

Phase: Phase 2

Type: Interventional

Design:

Primary Outcome: Numeric Rating Scale (NRS) at week 16

Secondary Outcome: Brief Pain Inventory (BPI)

Study sponsors, principal investigator, and references

Principal Investigator: Yamei Tang, M.D.,PhD.

Lead Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01869569

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