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A Study In Patients With Neuropathic Pain From Post-Herpetic Neuralgia (PHN)
This study is ongoing, but not recruiting participants.
First Received: February 7, 2008   Last Updated: April 30, 2009   History of Changes
Sponsored by: GlaxoSmithKline
Information provided by: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00619476
  Purpose

The purpose of this study is to determine whether XP13512/GSK1838262 is effective in the treatment of neuropathic pain associated with post-herpetic neuralgia (PHN)


Condition Intervention Phase
Neuropathic Pain Associated With Post-Herpetic Neuralgia
Drug: XP13512/GSK1838262
Phase II

MedlinePlus related topics: Shingles
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Official Title: Study PXN110748: An Efficacy and Safety Study of XP13512 Compared With a Concurrent Placebo Control in Subjects With Neuropathic Pain Associated With Post-Herpetic Neuralgia (PHN)

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • The change from baseline to end of treatment with respect to the mean 24-hour average pain intensity score based on an 11-point PI-NRS (0 = "no pain" and10 = "pain as bad as you can imagine"). [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percent of subjects achieving various levels of reduction in 24 hour average pain intensity score (derived from primary endpoint) [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • 24-hour, Day-time, Night time average pain intensity score; Current pain intensity score;Day-time and Night time worst pain intensity score;Sleep interference score;and Amount of rescue analgesic consumed. [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Time to onset of sustained improvement in the 24-hour average pain intensity score (sustained improvement is defined as a reduction of ≥2 points from baseline for ≥2 consecutive days) [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Day-time average pain intensity score recorded in the evening before bedtime. Day-time is defined as the time between rising in the morning and going to bed at night [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Night-time average pain intensity score recorded in the morning upon awakening. Night-time is defined as the time between going to bed at night and rising in the morning [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Current pain intensity score recorded in the morning upon awakening and in the evening before bedtime [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Day-time worst pain intensity score recorded in the evening before bedtime. Day-time is defined as the time between rising in the morning and going to bed at night [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Night-time worst pain intensity score recorded in the morning upon awakening. Night-time is defined as the time between going to bed at night and rising in the morning [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Sleep interference score recorded in the morning upon awakening. The sleep interference score is the subject's assessment of sleep interference due to pain [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Pain quality (completed in physician's office) [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Patient and clinician global impression of change (completed in physician's office) [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Dynamic allodynia (response to a standardized light touch stimulus, a foam brush applied with light pressure to the site of maximum pain) [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Rescue analgesic use [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Physical functioning (completed in physician's office) [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Quality of life (completed in physician's office) [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Emotional functioning (completed in physician's office) [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 368
Study Start Date: February 2008
Estimated Study Completion Date: July 2009
Estimated Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo: Placebo Comparator
placebo
Drug: XP13512/GSK1838262
Investigational product

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Prior to randomization, subjects eligible for enrollment in the study must meet all of the following criteria:

  • Outpatient subjects aged 18 years or older.
  • A female subject is eligible to enter and participate in the study if she:
  • Is of non-childbearing potential ; or
  • Is of child-bearing potential, is not lactating and has a negative pregnancy test ≤7 days prior to study treatment initiation and agrees to use one of the GlaxoSmithKine (GSK)-specified highly effective methods for avoiding pregnancy;
  • A documented medical diagnosis of PHN of at least three months duration prior to screening (i.e. pain present for at least three months from the healing of a herpes zoster skin rash).
  • A baseline 24-hour average pain intensity score ≥ 4.0 based on an 11-point PI-NRS. The baseline score is the calculated mean of the daily scores during the 7 days prior to randomization (Note: at least four assessments of the daily 24-hour average pain intensity score must have been recorded during the seven-day Baseline Period.)
  • Able to provide written informed consent prior to participation in the study. The contents and process of obtaining informed consent will be in accordance with all applicable regulatory requirements.

Exclusion Criteria:

Subjects meeting any of the following criteria must not be enrolled in the study:

  • Has other chronic pain conditions not associated with PHN. However, the subject will not be excluded if ALL the following criteria apply:
  • The pain is located at a different region of the body;
  • The pain intensity is not greater than the pain intensity of the PHN; and
  • The subject can assess PHN pain independently of the other pain condition.
  • Is unable to discontinue:
  • Prohibited medications, or
  • Non-drug therapies or procedures (i.e. nerve blocks, trans-cutaneous electrical nerve stimulation [TENS]) for the relief of pain of PHN for the required washout period and throughout the duration of the study.
  • Has any of the following medical conditions, laboratory abnormalities or disorders:
  • Hepatic impairment defined as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2x upper limit of normal (ULN), or alkaline phosphatase or bilirubin > 1.5x ULN.
  • Chronic hepatitis B or C with a positive Hepatitis B surface antigen (HBsAg) or Hepatitis C Core Antigen Antibody (Hep C antibody).
  • Impaired renal function defined as either creatinine clearance <60 mL/min (estimation of creatinine clearance by Cockroft and Gault Method) or renal dysfunction requiring hemodialysis.
  • Corrected QT (QTc) interval ≥ 450 msec (based on single or average QTc value of triplicate electrocardiograms (ECGs) obtained over a brief recording period).
  • QTc interval ≥480 msec for patients with Bundle Branch Block.
  • Uncontrolled hypertension at screen (sitting systolic blood pressure [SBP] >160 mmHg and/or sitting diastolic blood pressure [DBP] >90 mmHg).
  • Current diagnosis of active epilepsy or any active seizure disorder requiring chronic therapy with antiepileptic drugs.
  • Medical condition or disorder that would interfere with the action, absorption, distribution, metabolism, or excretion of XP13512, or, in the investigator's judgment.
  • Is considered to be clinically significant and may pose a safety concern, or,
  • Could interfere with the accurate assessment of safety or efficacy, or,
  • Could potentially affect a subject's safety or study outcome.

Examples of such medical conditions include:

  • Skin conditions at the site of the neuropathy.
  • Active infection at the site of the neuropathy.
  • Current or chronic history of liver disease (including acute viral hepatitis), or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
  • Meets criteria as defined by the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) for a major depressive episode or for active significant psychiatric disorders within last year, including dementia, general anxiety disorder, psychosis or bipolar disorder.
  • Subjects with a history of depression that is in remission, with or without antidepressant treatment, may participate, unless a stable antidepressant regimen includes a prohibited medication.
  • Antidepressant medication may not be changed or discontinued to meet entry criteria and must be stable for at least three months prior to the start of the Baseline Period.
  • Has a history of clinically significant drug or alcohol abuse as defined by DSM‑IV‑TR or is unable to refrain from substance abuse throughout the study. Benzodiazepines or atypical benzodiazepines prescribed as hypnotic sleep agents are permitted.
  • Is currently participating in another clinical study in which the subject is, or will be exposed to an investigational or non-investigational drug or device.
  • Has participated in a clinical study in which the subject was exposed to an investigational or non‑investigational drug or device:
  • Within the preceding month for studies unrelated to the current illness, or
  • Within the preceding six months for studies related to the current illness.
  • Has been treated previously with XP13512.
  • Has a history of an allergic reaction, or a medically significant adverse reaction to any of the following:
  • The investigational products (including gabapentin), or
  • Their excipients, or
  • Acetaminophen, or
  • Compounds closely related to acetaminophen.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00619476

  Show 86 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GSK ( Study Director )
Study ID Numbers: 110748
Study First Received: February 7, 2008
Last Updated: April 30, 2009
ClinicalTrials.gov Identifier: NCT00619476     History of Changes
Health Authority: United States: Food and Drug Administration;   Canada: Health Canada

Keywords provided by GlaxoSmithKline:
Neuropathic pain
Post-herpetic neuralgia

Study placed in the following topic categories:
Neuralgia, Postherpetic
Signs and Symptoms
Neuromuscular Diseases
Neuralgia
Peripheral Nervous System Diseases
Neurologic Manifestations
Pain

Additional relevant MeSH terms:
Neuralgia, Postherpetic
Signs and Symptoms
Neuromuscular Diseases
Neuralgia
Peripheral Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Pain

ClinicalTrials.gov processed this record on May 07, 2009