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Generated: December 9, 2018

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CLINICAL TRIALS PROFILE FOR CAPSAICIN

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Clinical Trials for Capsaicin

Trial ID Title Status Sponsor Phase Summary
NCT00001307 Positron Emission Tomography to Measure Pain and Pain Control Completed National Institute of Dental and Craniofacial Research (NIDCR) N/A This study will examine how the brain processes pain signals and how the different parts of the brain work with each other in response to painful stimuli. A better understanding of how people experience pain may be helpful in developing more effective treatments. Healthy normal volunteers, patients requiring third molar (wisdom tooth) extraction, and patients with persistent pain due to disease, injury or other reason may be eligible for this study. Participants will receive one or more of the following sensory stimuli, which may cause brief discomfort or pain: - Heat/Cold - applied by an electronically controlled device that touches the skin, or by temperature-controlled water baths, or by a thermally controlled brass cylinder the subject grasps - Capsaicin (active ingredient in hot chili peppers) - injected in a small volume of fluid under the skin or into a muscle - Mechanical stimulation - brushings or vibrations that do not normally cause pain - Ischemic stimulation - inflation of a blood pressure cuff on the arm or leg for up to 30 minutes These stimuli will be applied both before and during positron emission tomography (PET) scanning. This test shows which parts of the brain are active and which are not and is important for studying how different parts of the brain work together to feel and react to specific sensations. For this procedure, the subject lies on a table in the PET scanner while a series of scans are taken during different sensory conditions. At the beginning of each scan, radioactive water is injected into an arm vein through a catheter (a thin plastic tube). A special camera records the arrival and disappearance of the radiation in various brain areas, creating a picture of the brain's activity in various regions. Oral surgery patients may have PET scans both before and after their wisdom tooth extraction. Alfentanil, a commonly used narcotic pain reliever, will also be given during the PET procedure to determine how the brain responds to sensory stimuli while under the effects of a pain killer. Participants will also have a magnetic resonance imaging (MRI) scan of the brain to help interpret the PET results. MRI uses a magnetic field and radio waves to show structural and chemical changes in tissues. During the scan, the subject lies on a table in a cylindrical machine (the scanner). He or she can speak with a staff member via an intercom system. Some sensory studies may require placing an arterial and/or intravenous line. Following injection of a local anesthetic, a catheter is placed in an artery in the arm. At regular intervals during various sensory stimuli, small blood samples are drawn from the artery to measure blood gases and other substances. Samples may also be drawn from a catheter placed in a vein. Subjects may also have ultrasound monitoring to evaluate blood flow in the arteries, veins and brain. A gel is spread over the skin above the blood vessel and a hand-foot-and-mouth device is placed on the gel. The device emits high-frequency sound waves to produce a picture of the speed of blood flow in the artery and the diameter of the vessel.
NCT00004316 Phase I/II Randomized, Placebo-Controlled Study of Capsaicin for Interstitial Cystitis and Vulvar Vestibulitis Completed University of Pittsburgh Phase 1/Phase 2 OBJECTIVES: I. Estimate the optimal safe dose of intravesical capsaicin in patients with interstitial cystitis. II. Evaluate the efficacy of 0.025% topical capsaicin in relieving chronic burning pain in patients with vulvar vestibulitis. III. Evaluate the effect of capsaicin on type C nerve fibers in bladder mucosa and vulvar skin. IV. Evaluate the effect of C fiber depletion on urinary levels of histamine and prostaglandin.
NCT00004316 Phase I/II Randomized, Placebo-Controlled Study of Capsaicin for Interstitial Cystitis and Vulvar Vestibulitis Completed National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Phase 1/Phase 2 OBJECTIVES: I. Estimate the optimal safe dose of intravesical capsaicin in patients with interstitial cystitis. II. Evaluate the efficacy of 0.025% topical capsaicin in relieving chronic burning pain in patients with vulvar vestibulitis. III. Evaluate the effect of capsaicin on type C nerve fibers in bladder mucosa and vulvar skin. IV. Evaluate the effect of C fiber depletion on urinary levels of histamine and prostaglandin.
NCT00008476 Capsaicin to Control Pain Following Third Molar Extraction Completed National Institute of Dental and Craniofacial Research (NIDCR) Phase 2 This study will test the effectiveness of the drug capsaicin in controlling pain after third molar (wisdom tooth) extraction. Capsaicin, the ingredient in chili peppers that makes them "hot," belongs to a class of drugs called vanilloids, which have been found to temporarily inactivate pain-sensing nerves. Healthy normal volunteers between 16 and 40 years of age who require third molar (wisdom tooth) extraction may be eligible for this study. Participants will undergo the following procedures in three visits: Visit 1: Patients will have touch (sensory) testing by the following three methods: 1) a warm sensor applied to the gums and the patient will rate when they first feel heat and when the heat feels painful; 2) the bristles of a small paint brush will be gently stroked across the gums, and the patient will say whether it feels painful; 3) a light touch will be applied to the gums with a small needle, and the patient will rate the pain intensity following the touch. After testing, patients will be numbed with a local anesthetic (bupivacaine) and then capsaicin or placebo (an inactive solution) will be injected next to the tooth. The tooth then will be extracted one day later. Visit 2: Patients will return to the clinic after 24 hours to repeat the same type of sensory testing. After testing, patients will be sedated and numbed with a local anesthetic (lidocaine) and given an intravenous injection of either saline or ketorolac (30 mg). After the extraction, pain ratings will be recorded every 20 minutes, for up to 6 hours. During this time, patients will be monitored for numbness, pain, side effects and vital signs (heart rate, blood pressure, respiration, etc.). Those who request pain medicine will receive acetaminophen and codeine. Patients will be required to stay for up to 3 more hours after this and then they will then be discharged with pain medicine. Visit 3: Patients will return to the clinic after another 48 hours to repeat the same sensory testing. Remaining wisdom teeth will be removed "off-study" at least three weeks following the first visit.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Capsaicin

Condition Name

Condition Name for Capsaicin
Intervention Trials
Pain 28
Healthy 14
Neuropathic Pain 10
Hyperalgesia 9
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Condition MeSH

Condition MeSH for Capsaicin
Intervention Trials
Neuralgia 22
Cough 13
Osteoarthritis 12
Osteoarthritis, Knee 11
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Clinical Trial Locations for Capsaicin

Trials by Country

Trials by Country for Capsaicin
Location Trials
United States 156
United Kingdom 21
Denmark 13
Belgium 9
Italy 7
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Trials by US State

Trials by US State for Capsaicin
Location Trials
Florida 20
New York 13
California 12
North Carolina 11
Texas 9
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Clinical Trial Progress for Capsaicin

Clinical Trial Phase

Clinical Trial Phase for Capsaicin
Clinical Trial Phase Trials
Phase 4 22
Phase 3 10
Phase 2/Phase 3 8
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Clinical Trial Status

Clinical Trial Status for Capsaicin
Clinical Trial Phase Trials
Completed 85
Recruiting 27
Not yet recruiting 13
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Clinical Trial Sponsors for Capsaicin

Sponsor Name

Sponsor Name for Capsaicin
Sponsor Trials
NeurogesX 12
University of Florida 10
GlaxoSmithKline 6
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Sponsor Type

Sponsor Type for Capsaicin
Sponsor Trials
Other 119
Industry 72
NIH 15
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