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Trial record 58 of 87 for:    ASPIRIN AND thromboxane

Comparative Effects of Aspirin and NHP-544C

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ClinicalTrials.gov Identifier: NCT02189122
Recruitment Status : Completed
First Posted : July 14, 2014
Results First Posted : June 3, 2016
Last Update Posted : July 12, 2016
Sponsor:
Information provided by (Responsible Party):
Nancy J. Brown, Vanderbilt University

Brief Summary:
The investigators will compare the effects of rapid release aspirin and NHP-544C on the prostacyclin response to intravenous bradykinin.

Condition or disease Intervention/treatment Phase
Healthy Drug: Bradykinin Drug: Aspirin 81 mg Drug: Aspirin 162 mg Drug: NHP544-C 81 mg Drug: NHP544C 162 mg Drug: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Comparative Effects of Rapid-Release Aspirin and NHP-544C on Basal and Bradykinin Stimulated Prostacyclin Production
Study Start Date : July 2014
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin

Arm Intervention/treatment
Active Comparator: Group 1:Aspirin/placebo
Group 1 will be randomized to the order in which they receive rapid-release aspirin (ASA), 81 mg), ASA 162.5 mg, and identical-appearing placebo for 5 days. Bradykinin will be given intravenously in graded doses on the fifth day of each treatment period.
Drug: Bradykinin
Bradykinin will be given intravenously in graded doses. Each dose will be given for 15 minutes.
Other Name: BK

Drug: Aspirin 81 mg
Subjects will take Aspirin 81 mg per day for five days.
Other Name: ASA 81 mg

Drug: Aspirin 162 mg
Subjects will take aspirin 162 mg per day for 5 days.
Other Name: ASA 162 mg

Drug: Placebo
Subjects will take matching placebo for five days.

Active Comparator: Group 2:NHP-544C/placebo
Group 2 will be randomized to the order in which they receive NHP-544C 81 mg, NPH-544C 162.5 mg and identical-appearing placebo for five days. Bradykinin will be given intravenously in graded doses on the fifth day of each treatment period.
Drug: Bradykinin
Bradykinin will be given intravenously in graded doses. Each dose will be given for 15 minutes.
Other Name: BK

Drug: NHP544-C 81 mg
Subjects will take NHP544C 81 mg per day for five days.

Drug: NHP544C 162 mg
Subjects will take NHP544C 162 mg once a day for five days.

Drug: Placebo
Subjects will take matching placebo for five days.




Primary Outcome Measures :
  1. Urine Thromboxane Concentrations at Placebo ASA or Placebo NHP-544C Dose [ Time Frame: 24 hour collection ]
  2. Urine Thromboxane Concentrations at 81mg ASA or NHP-544C Dose [ Time Frame: 24 hour collection ]
  3. Urine Thromboxane Concentrations at 162.5 mg ASA or NHP-544C Dose [ Time Frame: 24 hour collection ]
  4. Urine Prostacyclin Concentrations at Placebo ASA or Placebo NHP-544C Dose [ Time Frame: 24 hour collection ]
  5. Urine Prostacyclin Concentrations at 81 mg ASA or NHP-544C Dose [ Time Frame: 24 hour collection ]
  6. Urine Prostacyclin Concentrations at 162.5 mg ASA or NHP-544C Dose [ Time Frame: 24 hour collection ]


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Ages of 18 and 55 years, inclusive
  2. No significant medical issues without significant abnormal findings at the baseline physical examination
  3. Body mass index (BMI) between 18.0 and 30.0kg/m2 (weight (kg)/[height(m)]2)
  4. For women - negative pregnancy test on Period 1, Day -1, or surgically sterilized, or is at least two years post-menopausal prior to randomization. Females of childbearing potential must be practicing an acceptable method of birth control to be eligible. Acceptable forms of birth control include: condom plus spermicide or condom plus other form of birth control including hormonal method (IUD, patch, ring, implant, or injectable), sterilization of partner, or non-hormonal IUD. The use of oral contraceptives is allowed during the study, but the subject must be on a stable dose for 30 days prior to the trial and throughout all four dosing periods
  5. Ability to understand the requirements of the study and a willingness to comply with all study procedures

Exclusion Criteria:

  1. Clinically significant and relevant medical history (including failure of a major organ system) or current medical illness, and is deemed by the Principal Investigator to be unsuitable to participate in the study
  2. Participation in an investigational drug study within the 30 days prior to CRC admission
  3. Use of aspirin or other NSAID within 14 days of Day 1 of the study. All other medications, prescription (with the exception of contraceptives), over-the-counter (OTC), herbal, and vitamin supplements must be discontinued 7 days prior to Day 1. If subjects are taking prescription medication, or OTC medication at the direction of a health care provider, that provider must confirm that it is acceptable for them to stop dosing for the duration of the study
  4. History of metabolic, renal, hepatic, hemorrhagic stroke, gastrointestinal bleed, cardiovascular disease, central nervous system disorder, or peptic ulcer disease or other chronic bleeding disorder
  5. History of gastrointestinal disorder that could result in incomplete absorption of the study drug
  6. Malignancy, or neurologic or psychiatric disorder
  7. Abnormal laboratory value(s) determined to be clinically significant (in the opinion of the Investigator)
  8. History of illicit drug abuse in the past year or current evidence of such abuse in the opinion of the investigator
  9. Pregnancy or lactation
  10. Acute illness within 1 week of CRC admission
  11. Significant loss of blood or blood or plasma donation within 30 days of drug administration
  12. Hypersensitivity or allergy to NSAIDs, aspirin, ethylcellulose, polyvidone, castor oil, magnesium stearate, tartaric acid, colloidal anhydrous silica, talc, gelatin, titanium dioxide, erythrosine, or indigotin
  13. History of aspirin resistance
  14. History of alcohol abuse within past year. Current alcohol use should not exceed 14 standard alcoholic drinks per week. A drink is defined as 1.5 ounces (oz.) liquor, 12 oz. beer, or 6 oz. wine
  15. Alcohol consumption within 3 days of Day 1
  16. Difficulty swallowing oral medications
  17. Consumption of coffee or caffeine-containing beverages exceeding the equivalent of five 8-oz cups of coffee per day on average

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02189122


Locations
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United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
Investigators
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Principal Investigator: Nancy J Brown, MD Vanderbilt University Medical Center

Publications of Results:
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Responsible Party: Nancy J. Brown, M.D.; Professor of Medicine and Pharmacology, Vanderbilt University
ClinicalTrials.gov Identifier: NCT02189122     History of Changes
Other Study ID Numbers: 140707
First Posted: July 14, 2014    Key Record Dates
Results First Posted: June 3, 2016
Last Update Posted: July 12, 2016
Last Verified: June 2016
Additional relevant MeSH terms:
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Aspirin
Bradykinin
Kininogens
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Vasodilator Agents
Cysteine Proteinase Inhibitors
Protease Inhibitors