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Trial record 11 of 424 for:    Pregabalin

Effect of Pregabalin in Patients With Radiotherapy-related Neuropathic Pain

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ClinicalTrials.gov Identifier: NCT01869569
Recruitment Status : Completed
First Posted : June 5, 2013
Last Update Posted : May 25, 2018
Sponsor:
Information provided by (Responsible Party):
Yamei Tang, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Neuropathic Pain Drug: Pregabalin Drug: Placebo Phase 2

Detailed Description:

Radiotherapy for cancer is associated with peripheral neuropathies, especially with brachial plexus neuropathy and trigeminal neuralgia, which included painful sensation that are described as burning, aching, spasm, or tingling. Though there is some recommendation about neuropathic pain, there is no definite drug which is recommended for radiotherapy-related neuropathic pain.

Pregabalin, a central nervous system(CNS)-active compound, is an analog of the neurotransmitter gamma-aminobutyric acid. It has been proved an effective treatment for diabetic peripheral neuropathy and postherpetic neuralgia in previous clinical trials. This study plans to evaluate the efficacy of pregabalin versus placebo for relieving radiotherapy-related peripheral neuropathic pain, and assessed its safety.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 137 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Pregabalin in Patients With Radiotherapy-Related Neuropathic Pain: a Randomized, Double-blind, Placebo-controlled Trial
Actual Study Start Date : February 2013
Actual Primary Completion Date : October 2016
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Pregabalin

Arm Intervention/treatment
Active Comparator: Pregabalin
Arm 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.
Drug: Pregabalin
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.
Other Name: Lyrica

Placebo Comparator: Placebo
Arm 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.
Drug: Placebo
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.




Primary Outcome Measures :
  1. Numeric Rating Scale (NRS) at week 16 [ Time Frame: week 16 ]
    The primary efficacy measure is the reduction of NRS from baseline to week 16.


Secondary Outcome Measures :
  1. Brief Pain Inventory (BPI) [ Time Frame: week 16 ]
    The investigators compare the BPI scores at week 16 with those at baseline.

  2. the Profile of Mood States-Short Form (POMS-SF) [ Time Frame: week 16 ]
    The investigators compare the POMS-SF scores at week 16 with those at baseline.

  3. the World Health Organization Quality of Life-BREF (WHOQOL-BREF) [ Time Frame: week 16 ]
    The investigators compare the WHOQOL-BREF scores at week 16 with those at baseline.

  4. Patient Global Impression of Change (PGIC) [ Time Frame: week 16 ]
    Number of Participants With Treatment Success at the End of Therapy as Measured by the Patient Global Impression of Change (PGIC). A treatment success is defined as Much or Very Much Improved at the Week 16. The PGIC is a 7-point Likert Scale, ranging from very much worse to very much improved

  5. Clinical Global Impression of Change (CGIC) [ Time Frame: week 16 ]
    Number of Participants With Treatment Success at the End of Therapy Based on Clinical Global Impression of Change (CGIC) . A treatment success is defined as Much or Very Much Improved at the Week 16. The PGIC is a 7-point Likert Scale, ranging from very much worse to very much improve.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT01869569


Locations
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China, Guangdong
Cancer Center of Sun Yat-sen University
Guangzhou, Guangdong, China, 510060
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, China, 510120
Guangzhou Huiai Hospital
Guangzhou, Guangdong, China, 510450
Zengcheng People's Hospital
Guangzhou, Guangdong, China, 511300
Sponsors and Collaborators
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Investigators
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Principal Investigator: Yamei Tang, M.D.,PhD. Department of Neurology, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University

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Responsible Party: Yamei Tang, Professor, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT01869569     History of Changes
Other Study ID Numbers: 2012026
SYSN002 ( Other Identifier: Sun Yat-sen Memorial Hospital, Neurology department )
First Posted: June 5, 2013    Key Record Dates
Last Update Posted: May 25, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Yamei Tang, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University:
Radiation
Neuropathic Pain
Pregabalin

Additional relevant MeSH terms:
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Pregabalin
Neuralgia
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs