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A 17-Week Trial To Assess Pregabalin For The Treatment Of Nerve Pain Due To Spinal Cord Injury

Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Neuralgia; Spinal Cord Injuries

Intervention: placebo (Drug); pregabalin (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Summary

The purpose of this study is to evaluate if pregabalin relieves nerve pain associated with spinal cord injury compared to placebo (pill that contains no active medicine). This study will also evaluate the safety of pregabalin in this patient population.

Clinical Details

Official title: A 17-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Trial Of Pregabalin For The Treatment Of Chronic Central Neuropathic Pain After Spinal Cord Injury

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

Primary outcome: Duration Adjusted Average Change (DAAC) of Mean Pain Score

Secondary outcome:

Change From Baseline in Weekly Mean Pain Score

Number of Participants With >=30% Reduction in Weekly Mean Pain Score From Baseline

Number of Participants With Categorical Scores on the Patient Global Impression of Change (PGIC) (Full Scale)

Change From Baseline in Weekly Mean Sleep Interference Score

Change From Baseline in Weekly Mean Pain Score by Week

Number of Participants With >=50% Reduction in Weekly Mean Pain Score From Baseline

Change From Baseline in Modified Brief Pain Inventory Interference Scale (10-Item) (mBPI-10) Total Score

Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP) - Static Mechanical Allodynia

Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP) - Dynamic Mechanical Allodynia

Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP)- Punctata Hyperalgesia

Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP)- Temporal Summation to Tactile Stimuli

Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP)- Cold Allodynia

Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP)- Cold Hyperalgesia Subscales

Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - 12 Items Total Intensity Score

Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Burning Spontaneous Pain

Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Pressing Spontaneous Pain

Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Paroxysmal Pain

Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Evoked Pain

Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Paresthesia/Dysesthesia

Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Individual Item (1, 2, 3, 5, 6, 8, 9, 10, 11, 12) Score

Number of Participants With Improved Duration of Brief Pain Attacks Based on NPSI - Duration (Item 4)

Number of Participants With Improvement in the Number of Attacks Based on NPSI - Number of Attacks (Item 7)

Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS)- 9-Item Overall Sleep Problems Index

Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Sleep Disturbance

Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Sleep Adequacy

Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Snoring

Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Awaken Short of Breath or With a Headache

Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Sleep Quantity

Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Somnolence

Number of Participants Having Optimal Sleep Based on Medical Outcomes Study Sleep Scale (MOS-SS)

Change From Baseline in Hospital and Anxiety Depression Scale (HADS) - Anxiety

Change From Baseline in Hospital and Anxiety Depression Scale (HADS) - Depression

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Subjects with nerve pain after Spinal cord injury (traumatic, diving, ischemic and

after removal of benign tumors (except meningioma and fibromas)

- Pain has to be chronic(continuous for at least 3 months or intermittent for at least

6 months

- Pain score at least 4 in 4 of 7 days prior to receive treatment.

Exclusion Criteria:

- Pregabalin use in the last 60 days, prior intolerance to pregabalin

- Creatinine clearance <60 mL/min.

- White blood cell count <2500/mm3; neutrophil count <1500/mm3; platelet count <100 x

103/ mm3.

- Abuse of drugs or alcohol

- Unstable medial conditions

- Clinically significant abnormal electrocardiogram (ECG).

- Presence of severe pain associated with conditions other than spinal cord injury that

could confound the assessment or self-evaluation of pain due to spinal cord injury.

Locations and Contacts

Pfizer Investigational Site, Beijing 100068, China

Pfizer Investigational Site, Brno 66250, Czech Republic

Pfizer Investigational Site, Liberec 1 46063, Czech Republic

Pfizer Investigational Site, Praha 5 15006, Czech Republic

Pfizer Investigational Site, Hong Kong, Hong Kong

Pfizer Investigational Site, New Delhi 110 070, India

Pfizer Investigational Site, Chiba, Japan

Pfizer Investigational Site, Tokushima, Japan

Pfizer Investigational Site, Yamagata, Japan

Pfizer Investigational Site, Cebu City, Philippines

Pfizer Investigational Site, Manila, Philippines

Pfizer Investigational Site, Quezon City 1100, Philippines

Pfizer Investigational Site, Moscow 105203, Russian Federation

Pfizer Investigational Site, St.Petersburg 197706, Russian Federation

Pfizer Investigational Site, Nagoya, Aichi, Japan

Pfizer Investigational Site, Daisen, Akita, Japan

Pfizer Investigational Site, Secunderabad, Andhra Pradesh 500 003, India

Pfizer Investigational Site, MedellĂ­n, Antioquia, Colombia

Pfizer Investigational Site, Phoenix, Arizona 85016, United States

Pfizer Investigational Site, Phoenix, Arizona 85027, United States

Pfizer Investigational Site, Phoenix, Arizona 85050, United States

Pfizer Investigational Site, Beijing, Beijing 100053, China

Pfizer Investigational Site, Fresno, California 93710, United States

Pfizer Investigational Site, Napa, California 94558, United States

Pfizer Investigational Site, Northridge, California 91324, United States

Pfizer Investigational Site, Pasadena, California 91105, United States

Pfizer Investigational Site, Miami, Florida 33136, United States

Pfizer Investigational Site, Miami, Florida 33125, United States

Pfizer Investigational Site, Orlando, Florida 32806, United States

Pfizer Investigational Site, Iizuka, Fukuoka, Japan

Pfizer Investigational Site, Fukuyama, Hiroshima, Japan

Pfizer Investigational Site, Bibai, Hokkaido, Japan

Pfizer Investigational Site, Hakodate, Hokkaido, Japan

Pfizer Investigational Site, Sapporo, Hokkaido, Japan

Pfizer Investigational Site, Kobe, Hyogo, Japan

Pfizer Investigational Site, Sasima-gun, Ibaraki, Japan

Pfizer Investigational Site, Indianapolis, Indiana 46250, United States

Pfizer Investigational Site, Kawasaki, Kanagawa, Japan

Pfizer Investigational Site, Overland Park, Kansas 66211, United States

Pfizer Investigational Site, Bangalore, Karnataka 560 034, India

Pfizer Investigational Site, Bangalore, Karnataka 560 052, India

Pfizer Investigational Site, Mangalore, Karnataka 575002, India

Pfizer Investigational Site, Kikuchi-gun, Kumamoto, Japan

Pfizer Investigational Site, Espana, Manila 1008, Philippines

Pfizer Investigational Site, Detroit, Michigan 48201, United States

Pfizer Investigational Site, Sendai, Miyagi, Japan

Pfizer Investigational Site, New York, New York 10029, United States

Pfizer Investigational Site, White Plains, New York 10605, United States

Pfizer Investigational Site, Kashiwazaki, Niigata, Japan

Pfizer Investigational Site, Winston-Salem, North Carolina 27103, United States

Pfizer Investigational Site, Bellevue, Ohio 44811, United States

Pfizer Investigational Site, Beppu, Oita, Japan

Pfizer Investigational Site, Johnstown, Pennsylvania 15904, United States

Pfizer Investigational Site, Philadelphia, Pennsylvania 19107, United States

Pfizer Investigational Site, Hanyu, Saitama, Japan

Pfizer Investigational Site, Kitamoto, Saitama, Japan

Pfizer Investigational Site, Hamamatsu, Shizuoka, Japan

Pfizer Investigational Site, Chengdu, Sichuan 610041, China

Pfizer Investigational Site, Dallas, Texas 75246, United States

Pfizer Investigational Site, Kanuma, Tochigi, Japan

Pfizer Investigational Site, Kotoku, Tokyo, Japan

Pfizer Investigational Site, Musashimurayama-shi, Tokyo, Japan

Pfizer Investigational Site, Lucknow, Uttar Pradesh 226 018, India

Pfizer Investigational Site, Vina del Mar, V Region 2520024, Chile

Pfizer Investigational Site, Charleston, West Virginia 25301, United States

Pfizer Investigational Site, Charleston, West Virginia 25304, United States

Pfizer Investigational Site, Higashiokitama-gun, Yamagata, Japan

Additional Information

To obtain contact information for a study center near you, click here.

Starting date: January 2007
Last updated: February 23, 2012

Page last updated: August 23, 2015

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