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A Clinical Study Of XP13512/GSK1838262 In Subjects With Neuropathic Pain From Post-Herpetic Neuralgia (PHN) Who Have Had An Inadequate Response To Gabapentin Treatment
This study is ongoing, but not recruiting participants.
First Received: February 6, 2008   Last Updated: July 30, 2009   History of Changes
Sponsor: GlaxoSmithKline
Information provided by: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00617461
  Purpose

The purpose of this study is evaluate the difference between two doses of XP13512/GSK1838262 on pain associated with post-herpetic neuralgia


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

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Crossover Assignment, Efficacy Study
Official Title: Study PXN110527: The Investigation of the Efficacy and Pharmacokinetics of XP13512 in Subjects With Neuropathic Pain Associated With Post-herpetic Neuralgia (PHN) Who Have Had an Inadequate Response to Gabapentin Treatment.

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • the mean daily average pain intensity score for the last week of each treatment period based on an 11-point PI-NRS (0 = "no pain" and 10 = "pain as bad as you can imagine"). [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 24-hour, Day-time, Night time average pain intensity score; Current pain intensity score;Day-time and Night time worst pain intensity score;Sleepinterference score;and Amount of rescue analgesic consumed. [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]
  • Percent of subjects achieving various levels of reduction in 24 hour average pain intensity score (derived from primary endpoint) [ Time Frame: 4 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: 4 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: 4 Weeks ] [ Designated as safety issue: No ]
  • Current pain intensity score recorded in the morning upon awakening and in the evening before bedtime. [ Time Frame: 4 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: 4 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: 4 Weeks ] [ Designated as safety issue: No ]
  • Sleep interference score recorded in the morning upon awakening [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]
  • Physical functioning (completed in physician's office) [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]
  • Patient and clinician global impression of change (completed in physician's office) [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]
  • Rescue analgesic use recorded in the evening before bedtime [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 98
Study Start Date: March 2008
Estimated Study Completion Date: July 2009
Estimated Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
XP13512: Experimental
1200mg and 3600mg
Drug: XP13512/GSK1838262
1200mg and 3600mg

  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, with a documented medical diagnosis of PHN of ≥3 months in duration prior to screening (i.e. pain present for at least 3 months from the healing of a herpes zoster skin rash).
  • 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 GSK specified highly effective methods for avoiding pregnancy
  • For the purposes of this study, PHN is defined as pain persisting for ≥ 3 months after healing of the shingles rash.

Subjects with the above definition of PHN must satisfy the following criteria to be eligible for the study:

  • Subjects currently on a stable dose of 1800 mg/day of gabapentin for 2 weeks or more since the diagnosis of PHN, with inadequate response;
  • Subjects not currently treated with gabapentin but previously treated with ≥ 1800 mg/day of gabapentin for 4 weeks or more since the diagnosis of PHN with inadequate response.

Subjects may previously have been on >1800 mg/day of gabapentin since diagnosis of PHN.

  • The baseline 24-hour average pain intensity score is >4.0 based on an 11-point PI‑NRS. The baseline score is the calculated mean of the daily scores (based on at least 4 assessments) taken during the 7 days prior to randomization. Subjects are to continue to take gabapentin 1800mg/day provided by GSK during the Baseline Period.
  • Subject is compliant with the gabapentin treatment supplied during the 14-day Baseline Period. Compliant is defined as administering >80% of the total supplied treatment over the 14-day Baseline Period.
  • Subject is 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 drug(s).
  • Medical condition or disorder that would interfere with the action, absorption, distribution, metabolism, or excretion of XP13512, or, in the investigator's judgement:
  • Is considered to be clinically significant and could 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: NCT00617461

  Show 55 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: 110527
Study First Received: February 6, 2008
Last Updated: July 30, 2009
ClinicalTrials.gov Identifier: NCT00617461     History of Changes
Health Authority: United States: Food and Drug Administration;   United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Neuropathic pain
Post-herpetic neuralgia(PHN)

Additional relevant MeSH terms:
Neuralgia, Postherpetic
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Gabapentin
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Psychotropic Drugs
Antiparkinson Agents
Calcium Channel Blockers
Excitatory Amino Acid Agents
Pain
Membrane Transport Modulators
Signs and Symptoms
Neuromuscular Diseases
Sensory System Agents
Therapeutic Uses
Analgesics
Excitatory Amino Acid Antagonists
Tranquilizing Agents
Neuralgia
Nervous System Diseases
Central Nervous System Depressants
Cardiovascular Agents
Antimanic Agents
Pharmacologic Actions
Peripheral Nervous System Diseases
Neurologic Manifestations
Anti-Anxiety Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 27, 2009