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Serving leading biopharmaceutical companies globally:

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Generated: November 19, 2017

DrugPatentWatch Database Preview

CLINICAL TRIALS PROFILE FOR
AMITRIPTYLINE HYDROCHLORIDE

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Clinical Trial Listing

Trial ID Title Status Sponsor Phase Summary
NCT00000428 Combining N-of-1 Trials to Assess Fibromyalgia TreatmentsCompletedNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)Phase 4 This study will compare the effectiveness of combination therapy with the drugs amitriptyline and fluoxetine (AM+FL) and amitriptyline (AM) alone in the treatment of people with fibromyalgia. Doctors will treat each study participant with both AM + FL and AM alone for 6 weeks at a time. The study uses a method that combines results from treatment of individual patients to assess overall treatment effectiveness and help individual patients and their physicians with their treatment decisions. This study will also help compare the results of community-based studies (studies involving private doctors) and studies based at clinical research centers.
NCT00000428 Combining N-of-1 Trials to Assess Fibromyalgia TreatmentsCompletedTufts Medical CenterPhase 4 This study will compare the effectiveness of combination therapy with the drugs amitriptyline and fluoxetine (AM+FL) and amitriptyline (AM) alone in the treatment of people with fibromyalgia. Doctors will treat each study participant with both AM + FL and AM alone for 6 weeks at a time. The study uses a method that combines results from treatment of individual patients to assess overall treatment effectiveness and help individual patients and their physicians with their treatment decisions. This study will also help compare the results of community-based studies (studies involving private doctors) and studies based at clinical research centers.
NCT00000793 A Phase II/III Double-Blind Study of Amitriptyline and Mexiletine for Painful Neuropathy in HIV InfectionCompletedBoehringer IngelheimPhase 2 To assess the efficacy, safety, and tolerability of amitriptyline hydrochloride versus mexiletine hydrochloride in reducing pain intensity in patients with HIV-related painful peripheral neuropathy. No large-scale controlled clinical trials of symptomatic therapy for painful HIV-related neuropathy have been attempted. Both amitriptyline and mexiletine have been useful in the management of painful neuropathies; however, both are associated with certain toxicities. In this comparative study of amitriptyline and mexiletine, benztropine mesylate also will be included as an active placebo to mimic the side effects of the study drugs.
NCT00000793 A Phase II/III Double-Blind Study of Amitriptyline and Mexiletine for Painful Neuropathy in HIV InfectionCompletedNational Institute of Allergy and Infectious Diseases (NIAID)Phase 2 To assess the efficacy, safety, and tolerability of amitriptyline hydrochloride versus mexiletine hydrochloride in reducing pain intensity in patients with HIV-related painful peripheral neuropathy. No large-scale controlled clinical trials of symptomatic therapy for painful HIV-related neuropathy have been attempted. Both amitriptyline and mexiletine have been useful in the management of painful neuropathies; however, both are associated with certain toxicities. In this comparative study of amitriptyline and mexiletine, benztropine mesylate also will be included as an active placebo to mimic the side effects of the study drugs.
NCT00000817 The Efficacy of a Standardized Acupuncture Regimen and Amitriptyline Compared With Placebo as a Treatment for Pain Caused by Peripheral Neuropathy in HIV-Infected PatientsCompletedNational Institute of Allergy and Infectious Diseases (NIAID)N/A To evaluate the separate and combined efficacy of a standardized acupuncture regimen and amitriptyline on the relief of pain due to peripheral neuropathy and on the quality of life of HIV-infected patients. Both amitriptyline, an antidepressant, and acupuncture, a Chinese medical approach that uses needles to relieve pain, have been used successfully to reduce pain in some people. It is not known how effectively these approaches relieve or reduce pain in patients with peripheral neuropathy secondary to HIV infection.
NCT00006427 Chronic Pain After AmputationCompletedEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Phase 4 This trial will test the effectiveness of amitriptyline in relieving chronic pain of adults that have had an amputation
NCT00006428 Chronic Pain in Spinal Cord InjuryCompletedEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Phase 4 This trial tests the effectiveness of the drug amitriptyline vs placebo to relieve chronic pain in adults that have had a spinal cord injury.
NCT00029497 Sham Device, Pill Placebo or Treatment For Arm PainCompletedNational Center for Complementary and Integrative Health (NCCIH)Phase 2 This study investigates the role of two active interventions and their placebo effects in randomized control trials. The study conducts two parallel trials of treatments for upper extremity pain secondary to repetitive stress disorder, including carpal tunnel syndrome. The active interventions are amitriptyline and acupuncture. The placebo are sham acupuncture device and placebo pill.
NCT00108550 Chronic Low Back Pain Research ProjectCompletedVA Office of Research and DevelopmentPhase 2 The purpose of this study is to determine whether gabapentin is efficacious as an analgesic for chronic low back pain.
NCT00124306 Efficacy of Amitriptyline for Painful Bladder Syndrome (PBS)CompletedUniversity of PennsylvaniaPhase 3 This is a randomized clinical trial study to test the efficacy and safety of amitriptyline in the treatment of patients newly diagnosed with painful bladder syndrome (PBS). PBS is defined by symptoms--frequent urination day and night and increasing pain as the bladder fills--according to the International Continence Society. The syndrome includes interstitial cystitis (IC), which has been estimated to affect as many as 700,000 people, mostly women. Estimates for PBS vary widely, but as many as 10 million people may suffer from this condition. Although amitriptyline is a Food and Drug Administration (FDA)-approved medication used for depression, the way it works makes it useful for treating the pain of fibromyalgia, multiple sclerosis, and other chronic pain syndromes. Prior small studies in interstitial cystitis (IC) suggested the drug may be a wise choice for this syndrome as well, because it blocks nerve signals that trigger pain and may also decrease muscle spasms in the bladder, helping to relieve the symptoms of pain and frequent urination.
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Conditions

Condition Name

Condition Name for amitriptyline hydrochloride
Intervention Trials
Fibromyalgia 10
Pain 9
Migraine 7
Depression 5
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Condition MeSH

Condition MeSH for amitriptyline hydrochloride
Intervention Trials
Fibromyalgia 10
Neuralgia 10
Myofascial Pain Syndromes 10
Migraine Disorders 9
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Trial Locations

Trials by Country

Trials by Country for amitriptyline hydrochloride
Location Trials
United States 142
Canada 12
Brazil 9
Germany 9
Israel 5
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Trials by US State

Trials by US State for amitriptyline hydrochloride
Location Trials
Washington 9
Ohio 7
New York 7
Illinois 7
Massachusetts 6
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Clinical Trial Progress

Clinical Trial Phase

Clinical Trial Phase for amitriptyline hydrochloride
Clinical Trial Phase Trials
Phase 4 20
Phase 3 20
Phase 2/Phase 3 6
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Clinical Trial Status

Clinical Trial Status for amitriptyline hydrochloride
Clinical Trial Phase Trials
Completed 52
Recruiting 14
Unknown status 12
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Clinical Trial Sponsors

Sponsor Name

Sponsor Name for amitriptyline hydrochloride
Sponsor Trials
Federal University of São Paulo 4
Ortho-McNeil Neurologics, Inc. 3
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) 3
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Sponsor Type

Sponsor Type for amitriptyline hydrochloride
Sponsor Trials
Other 99
Industry 22
NIH 16
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Serving leading biopharmaceutical companies globally:

McKinsey
Teva
Boehringer Ingelheim
US Department of Justice
Harvard Business School
US Army
Deloitte
Express Scripts
McKesson
Queensland Health

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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