Nctid:
NCT00001344
Payload:
{"FullStudy"=>{"Rank"=>498025, "Study"=>{"DerivedSection"=>{"MiscInfoModule"=>{"VersionHolder"=>"June 24, 2024"}, "ConditionBrowseModule"=>{"ConditionMeshList"=>{"ConditionMesh"=>[{"ConditionMeshId"=>"D000006562", "ConditionMeshTerm"=>"Herpes Zoster"}, {"ConditionMeshId"=>"D000009437", "ConditionMeshTerm"=>"Neuralgia"}, {"ConditionMeshId"=>"D000003929", "ConditionMeshTerm"=>"Diabetic Neuropathies"}]}, "ConditionAncestorList"=>{"ConditionAncestor"=>[{"ConditionAncestorId"=>"D000010523", "ConditionAncestorTerm"=>"Peripheral Nervous System Diseases"}, {"ConditionAncestorId"=>"D000009468", "ConditionAncestorTerm"=>"Neuromuscular Diseases"}, {"ConditionAncestorId"=>"D000009422", "ConditionAncestorTerm"=>"Nervous System Diseases"}, {"ConditionAncestorId"=>"D000010146", "ConditionAncestorTerm"=>"Pain"}, {"ConditionAncestorId"=>"D000009461", "ConditionAncestorTerm"=>"Neurologic Manifestations"}, {"ConditionAncestorId"=>"D000048909", "ConditionAncestorTerm"=>"Diabetes Complications"}, {"ConditionAncestorId"=>"D000003920", "ConditionAncestorTerm"=>"Diabetes Mellitus"}, {"ConditionAncestorId"=>"D000004700", "ConditionAncestorTerm"=>"Endocrine System Diseases"}, {"ConditionAncestorId"=>"D000073618", "ConditionAncestorTerm"=>"Varicella Zoster Virus Infection"}, {"ConditionAncestorId"=>"D000006566", "ConditionAncestorTerm"=>"Herpesviridae Infections"}, {"ConditionAncestorId"=>"D000004266", "ConditionAncestorTerm"=>"DNA Virus Infections"}, {"ConditionAncestorId"=>"D000014777", "ConditionAncestorTerm"=>"Virus Diseases"}, {"ConditionAncestorId"=>"D000007239", "ConditionAncestorTerm"=>"Infections"}]}, "ConditionBrowseLeafList"=>{"ConditionBrowseLeaf"=>[{"ConditionBrowseLeafId"=>"M7115", "ConditionBrowseLeafName"=>"Diabetes Mellitus", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M7124", "ConditionBrowseLeafName"=>"Diabetic Neuropathies", "ConditionBrowseLeafAsFound"=>"Diabetic Neuropathy", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M12381", "ConditionBrowseLeafName"=>"Neuralgia", "ConditionBrowseLeafAsFound"=>"Neuralgia", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M9639", "ConditionBrowseLeafName"=>"Herpes Simplex", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M9640", "ConditionBrowseLeafName"=>"Herpes Zoster", "ConditionBrowseLeafAsFound"=>"Herpes Zoster", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M13066", "ConditionBrowseLeafName"=>"Pain", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M26725", "ConditionBrowseLeafName"=>"Neuralgia, Postherpetic", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M13432", "ConditionBrowseLeafName"=>"Peripheral Nervous System Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M12411", "ConditionBrowseLeafName"=>"Neuromuscular Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M12404", "ConditionBrowseLeafName"=>"Neurologic Manifestations", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M26004", "ConditionBrowseLeafName"=>"Diabetes Complications", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M7862", "ConditionBrowseLeafName"=>"Endocrine System Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M10283", "ConditionBrowseLeafName"=>"Infections", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M6368", "ConditionBrowseLeafName"=>"Communicable Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M17522", "ConditionBrowseLeafName"=>"Virus Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M5888", "ConditionBrowseLeafName"=>"Chickenpox", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M1200", "ConditionBrowseLeafName"=>"Varicella Zoster Virus Infection", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M9643", "ConditionBrowseLeafName"=>"Herpesviridae Infections", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M7442", "ConditionBrowseLeafName"=>"DNA Virus Infections", "ConditionBrowseLeafRelevance"=>"low"}]}, "ConditionBrowseBranchList"=>{"ConditionBrowseBranch"=>[{"ConditionBrowseBranchName"=>"Nutritional and Metabolic Diseases", "ConditionBrowseBranchAbbrev"=>"BC18"}, {"ConditionBrowseBranchName"=>"Gland and Hormone Related Diseases", "ConditionBrowseBranchAbbrev"=>"BC19"}, {"ConditionBrowseBranchName"=>"All Conditions", "ConditionBrowseBranchAbbrev"=>"All"}, {"ConditionBrowseBranchName"=>"Nervous System Diseases", "ConditionBrowseBranchAbbrev"=>"BC10"}, {"ConditionBrowseBranchName"=>"Symptoms and General Pathology", "ConditionBrowseBranchAbbrev"=>"BC23"}, {"ConditionBrowseBranchName"=>"Infections", "ConditionBrowseBranchAbbrev"=>"BC01"}, {"ConditionBrowseBranchName"=>"Skin and Connective Tissue Diseases", "ConditionBrowseBranchAbbrev"=>"BC17"}]}}, "InterventionBrowseModule"=>{"InterventionMeshList"=>{"InterventionMesh"=>[{"InterventionMeshId"=>"C000728178", "InterventionMeshTerm"=>"Levomethorphan"}, {"InterventionMeshId"=>"D000003915", "InterventionMeshTerm"=>"Dextromethorphan"}]}, "InterventionAncestorList"=>{"InterventionAncestor"=>[{"InterventionAncestorId"=>"D000000996", "InterventionAncestorTerm"=>"Antitussive Agents"}, {"InterventionAncestorId"=>"D000019141", "InterventionAncestorTerm"=>"Respiratory System Agents"}, {"InterventionAncestorId"=>"D000018691", "InterventionAncestorTerm"=>"Excitatory Amino Acid Antagonists"}, {"InterventionAncestorId"=>"D000018683", "InterventionAncestorTerm"=>"Excitatory Amino Acid Agents"}, {"InterventionAncestorId"=>"D000018377", "InterventionAncestorTerm"=>"Neurotransmitter Agents"}, {"InterventionAncestorId"=>"D000045504", "InterventionAncestorTerm"=>"Molecular Mechanisms of Pharmacological Action"}, {"InterventionAncestorId"=>"D000045505", "InterventionAncestorTerm"=>"Physiological Effects of Drugs"}, {"InterventionAncestorId"=>"D000000701", "InterventionAncestorTerm"=>"Analgesics, Opioid"}, {"InterventionAncestorId"=>"D000009294", "InterventionAncestorTerm"=>"Narcotics"}, {"InterventionAncestorId"=>"D000002492", "InterventionAncestorTerm"=>"Central Nervous System Depressants"}, {"InterventionAncestorId"=>"D000000700", "InterventionAncestorTerm"=>"Analgesics"}, {"InterventionAncestorId"=>"D000018689", "InterventionAncestorTerm"=>"Sensory System Agents"}, {"InterventionAncestorId"=>"D000018373", "InterventionAncestorTerm"=>"Peripheral Nervous System Agents"}]}, "InterventionBrowseLeafList"=>{"InterventionBrowseLeaf"=>[{"InterventionBrowseLeafId"=>"M351583", "InterventionBrowseLeafName"=>"Levomethorphan", "InterventionBrowseLeafAsFound"=>"Tele-", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M7110", "InterventionBrowseLeafName"=>"Dextromethorphan", "InterventionBrowseLeafAsFound"=>"Tele-", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M11542", "InterventionBrowseLeafName"=>"Memantine", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M13570", "InterventionBrowseLeafName"=>"Phenylpropanolamine", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M9238", "InterventionBrowseLeafName"=>"Guaifenesin", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M186319", "InterventionBrowseLeafName"=>"Chlorpheniramine, phenylpropanolamine drug combination", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M4312", "InterventionBrowseLeafName"=>"Antitussive Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M21137", "InterventionBrowseLeafName"=>"Respiratory System Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M20771", "InterventionBrowseLeafName"=>"Excitatory Amino Acid Antagonists", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M20504", "InterventionBrowseLeafName"=>"Neurotransmitter Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M4032", "InterventionBrowseLeafName"=>"Analgesics", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M4033", "InterventionBrowseLeafName"=>"Analgesics, Opioid", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M12245", "InterventionBrowseLeafName"=>"Narcotics", "InterventionBrowseLeafRelevance"=>"low"}]}, "InterventionBrowseBranchList"=>{"InterventionBrowseBranch"=>[{"InterventionBrowseBranchName"=>"Analgesics", "InterventionBrowseBranchAbbrev"=>"Analg"}, {"InterventionBrowseBranchName"=>"Central Nervous System Depressants", "InterventionBrowseBranchAbbrev"=>"CNSDep"}, {"InterventionBrowseBranchName"=>"All Drugs and Chemicals", "InterventionBrowseBranchAbbrev"=>"All"}, {"InterventionBrowseBranchName"=>"Antitussive Agents", "InterventionBrowseBranchAbbrev"=>"AnTuAg"}, {"InterventionBrowseBranchName"=>"Respiratory System Agents", "InterventionBrowseBranchAbbrev"=>"Resp"}, {"InterventionBrowseBranchName"=>"Anti-Dyskinesia Agents", "InterventionBrowseBranchAbbrev"=>"AnDyAg"}, {"InterventionBrowseBranchName"=>"Anti-Obesity Agents", "InterventionBrowseBranchAbbrev"=>"AnObAg"}, {"InterventionBrowseBranchName"=>"Vasoconstrictor Agents", "InterventionBrowseBranchAbbrev"=>"VaCoAg"}]}}}, "ProtocolSection"=>{"DesignModule"=>{"PhaseList"=>{"Phase"=>["Phase 2"]}, "StudyType"=>"Interventional", "DesignInfo"=>{"DesignPrimaryPurpose"=>"Treatment"}, "EnrollmentInfo"=>{"EnrollmentCount"=>"129"}}, "StatusModule"=>{"OverallStatus"=>"Completed", "StartDateStruct"=>{"StartDate"=>"March 1993"}, "ExpandedAccessInfo"=>{"HasExpandedAccess"=>"No"}, "StatusVerifiedDate"=>"March 2000", "CompletionDateStruct"=>{"CompletionDate"=>"February 2001"}, "LastUpdateSubmitDate"=>"March 3, 2008", "StudyFirstSubmitDate"=>"November 3, 1999", "StudyFirstSubmitQCDate"=>"December 9, 2002", "LastUpdatePostDateStruct"=>{"LastUpdatePostDate"=>"March 4, 2008", "LastUpdatePostDateType"=>"Estimate"}, "StudyFirstPostDateStruct"=>{"StudyFirstPostDate"=>"December 10, 2002", "StudyFirstPostDateType"=>"Estimate"}}, "OversightModule"=>{}, "ConditionsModule"=>{"KeywordList"=>{"Keyword"=>["Diabetes Mellitus", "Diabetic Neuropathy", "Memantine", "NMDA Receptor Antagonists", "Neuropathic Pain", "Neuropathy", "Post-Herpetic Neuralgia", "Shingles"]}, "ConditionList"=>{"Condition"=>["Diabetic Neuropathies", "Herpes Zoster", "Neuralgia"]}}, "ReferencesModule"=>{"ReferenceList"=>{"Reference"=>[{"ReferencePMID"=>"1866755", "ReferenceType"=>"background", "ReferenceCitation"=>"Albers GW, Saenz RE, Moses JA Jr, Choi DW. Safety and tolerance of oral dextromethorphan in patients at risk for brain ischemia. Stroke. 1991 Aug;22(8):1075-7. doi: 10.1161/01.str.22.8.1075."}, {"ReferencePMID"=>"1967971", "ReferenceType"=>"background", "ReferenceCitation"=>"Bakshi R, Faden AI. Competitive and non-competitive NMDA antagonists limit dynorphin A-induced rat hindlimb paralysis. Brain Res. 1990 Jan 15;507(1):1-5. doi: 10.1016/0006-8993(90)90512-a."}, {"ReferencePMID"=>"2881608", "ReferenceType"=>"background", "ReferenceCitation"=>"Choi DW. Dextrorphan and dextromethorphan attenuate glutamate neurotoxicity. Brain Res. 1987 Feb 17;403(2):333-6. doi: 10.1016/0006-8993(87)90070-9."}]}}, "DescriptionModule"=>{"BriefSummary"=>"In our current clinical trial, we are comparing the effects of two NMDA receptor antagonists to placebo in patients with painful distal symmetrical diabetic neuropathy or post-herpetic neuralgia. The treatments in this three-period crossover study are dextromethorphan, up to 920 mg/day (about 8 times the antitussive dose), memantine, 30-50 mg/day, and placebo. Memantine is an NMDA antagonist used in Europe to treat Parkinson's disease and Alzheimer's disease. The underlying hypothesis, based on studies of painful neuropathies in animal models, is that neuropathic pain is caused largely by sensitization of central nervous system neurons caused by excitatory amino acid neurotransmitters, acting largely through NMDA receptors. A previous small trial of dextromethorphan suggested efficacy in diabetic neuropathy pain. The study requires one visit to the NIH outpatient Pain Research Clinic, and consists of three 9-week treatment periods. Patients who respond to one of the medications will be invited to participate in further controlled studies of the medication followed by up to several years of open-label treatment under continued observation.", "DetailedDescription"=>"In our current clinical trial, we are comparing the effects of two NMDA receptor antagonists to placebo in patients with painful distal symmetrical diabetic neuropathy or post-herpetic neuralgia. The treatments in this three-period crossover study are dextromethorphan, up to 920 mg/day (about 8 times the antitussive dose), memantine, 30-50 mg/day, and placebo. Memantine is an NMDA antagonist used in Europe to treat Parkinson's disease and Alzheimer's disease. The underlying hypothesis, based on studies of painful neuropathies in animal models, is that neuropathic pain is caused largely by sensitization of central nervous system neurons caused by excitatory amino acid neurotransmitters, acting largely through NMDA receptors. A previous small trial of dextromethorphan suggested efficacy in diabetic neuropathy pain. The study requires one visit to the NIH outpatient Pain Research Clinic, and consists of three 9-week treatment periods. Patients who respond to one of the medications will be invited to participate in further controlled studies of the medication followed by up to several years of open-label treatment under continued observation."}, "EligibilityModule"=>{"Gender"=>"All", "StdAgeList"=>{"StdAge"=>["Child", "Adult", "Older Adult"]}, "HealthyVolunteers"=>"No", "EligibilityCriteria"=>"Patients must be over 18 years of age.\n\nPatients must have a definite diagnosis of diabetic neuropathy or post herpetic neuralgia or a diagnosis of neuropathic pain of various etiologies other than diabetic neuropathy or post herpetic neuralgia.\n\nDuration of symptoms must be at least 3 months.\n\nSeverity of pain must be at least mild, if constant; or at least moderate, if intermittent and at least 2 hours duration a day.\n\nPatients using tricyclics, narcotics, or antiseizure medications, must keep the drug dosages constant throughout the study.\n\nNo patients with unstable disease process; i.e., angina pectoris, accelerated hypertension, recent stroke or transient cerebral ischemia, uncontrolled seizures.\n\nNo pregnant or lactating women. Women of child bearing potential must use birth control pills, intrauterine device, or barrier contraceptive devices.\n\nNo history of significant drug abuse or PCP use. No history of IV drug abuse, prescription drug abuse, or alcoholism.\n\nNo significant liver or kidney disease.\n\nNo MAO inhibitors.\n\nNo cognitive impairment or language difficulty as judged by difficulty completing pain diary, medical history, or telephone conversation.\n\nPatients must not have any other chronic pain condition that gives them pain greater than the neuropathy pain."}, "IdentificationModule"=>{"NCTId"=>"NCT00001344", "BriefTitle"=>"Dextromethorphan Versus Placebo for Neuropathic Pain", "Organization"=>{"OrgClass"=>"NIH", "OrgFullName"=>"National Institutes of Health Clinical Center (CC)"}, "OfficialTitle"=>"Dextromethorphan Versus Placebo for Neuropathic Pain", "OrgStudyIdInfo"=>{"OrgStudyId"=>"930114"}, "SecondaryIdInfoList"=>{"SecondaryIdInfo"=>[{"SecondaryId"=>"93-D-0114"}]}}, "ArmsInterventionsModule"=>{"InterventionList"=>{"Intervention"=>[{"InterventionName"=>"dextromethorphan", "InterventionType"=>"Drug"}]}}, "ContactsLocationsModule"=>{"LocationList"=>{"Location"=>[{"LocationZip"=>"20892", "LocationCity"=>"Bethesda", "LocationState"=>"Maryland", "LocationCountry"=>"United States", "LocationFacility"=>"National Institute of Dental And Craniofacial Research (NIDCR)"}]}}, "SponsorCollaboratorsModule"=>{"LeadSponsor"=>{"LeadSponsorName"=>"National Institute of Dental and Craniofacial Research (NIDCR)", "LeadSponsorClass"=>"NIH"}}}}}}
