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Effect of Repeated Dosing of Naproxcinod on Renal Hemodynamic and on Sodium Balance in Healthy Volunteers Before and After a Single Dose of Furosemide

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00909519
Recruitment Status : Completed
First Posted : May 28, 2009
Last Update Posted : June 17, 2011
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Brief Summary:
This phase 1 study is an 8-day treatment period, randomized, controlled, double-blind, 3 parallel-groups, monocentric study. The primary objective is to evaluate the effect of naproxcinod on the renal function when co-administered with furosemide in comparison to naproxen and placebo.

Condition or disease Intervention/treatment Phase
Renal Hemodynamics Drug: naproxcinod Drug: Naproxen Drug: placebo Drug: furosemide Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: A Phase 1, Single-Center, Randomized, Parallel-group, Placebo- and Naproxen- Controlled, Double-blind Study to Evaluate the Effect of Naproxcinod 750 mg Bid Administered for 8 Days on the Renal Hemodynamics, Natriuretic and Renin Responses to a Single Bolus IV Dose of Furosemide 40 mg in Male Healthy Normotensive Volunteers
Study Start Date : January 2009
Actual Primary Completion Date : April 2009
Actual Study Completion Date : April 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: naproxen Drug: Naproxen
Naproxen 500 mg bid

Experimental: naproxcinod Drug: naproxcinod
naproxcinod 750 mg bid

Drug: furosemide

Placebo Comparator: placebo Drug: placebo

Primary Outcome Measures :
  1. To evaluate the effect of naproxcinod on the renal function when co-administered with furosemide in comparison to naproxen and placebo [ Time Frame: Day 8, between H3 and H9 ]

Secondary Outcome Measures :
  1. to assess the effect of naproxcinod on blood pressure (BP) in comparison with naproxen and placebo over 1 week and when co-administered with furosemide + to assess the general safety and tolerability [ Time Frame: for over 1 week ]
  2. To evaluate the effect of naproxcinod when administered alone on renal function, after a week of administration, in comparison with naproxen and placebo. [ Time Frame: Day 8 at H4 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. Healthy, non smoker male subjects aged 18 and 35 years (inclusive), at the Screening visit.
  2. Body Mass Index (BMI) strictly between 18 and 30 kg/m² (inclusive) with body weight≥ 50 kg at the Screening visit.
  3. Normal physical examination at the Screening visit.
  4. Normal ECG (12-lead) at the Screening visit, as judged by the Investigator.
  5. At Screening and run-in period visits , Systolic Blood Pressure (SBP) between 100 and 139 mmHg (inclusive) and Diastolic Blood Pressure (DBP) between 50 and 89 mmHg (inclusive).
  6. At Screening and run-in period visits, HR between 45 and 90 bpm (inclusive).
  7. Subjects must be able to understand the written information sheet and informed consent and comply with all study requirements.
  8. Subjects must provide a written, dated and signed informed consent prior to any study procedure.

Exclusion Criteria:

  1. A history of hypersensitivity reactions (such as asthma, rhinitis, or urticaria) to aspirin, naproxen or any other NSAIDs; or hypersensitivity or contraindications to organic nitrate drugs or hypersensitivity to furosemide or to sinistrine or PAH.
  2. Family history of hypertension which may disqualify the subject, as judged by the investigator..
  3. History of any clinically relevant gastrointestinal (such as gastritis or gastric ulcer), respiratory, psychiatric, neurologic, kidney, liver, cardiac disease, bleeding disorder, other disease/condition or abnormal physical finding which may interfere with the study objectives. The investigator may disqualify any subject for a sound medical or psychiatric reason.
  4. History or presence of ASAT >40UI/L, ALAT >40UI/L, serum bilirubin 3 times above the Upper Limit of Normal range at the Screening visit.
  5. Creatinine clearance inferior/equal to 80 ml/min as calculated with the Cockcroft-Gault formula (Appendix 5 of the protocol) at the Screening visit.
  6. Plasmatic potassium <3.5 mmole/L at the Screening visit.
  7. Seropositivity for HBs, HBc, HIV 1 or HIV 2 at the Screening visit.
  8. Donations of blood, plasma or platelets within 3 months prior to the Screening visit or donation planned during the 3 months following Day 8.
  9. Any clinically significant abnormal laboratory values at the Screening visit.
  10. At the Screening visit, after 1 minute in a standing position, a drop of more than 20 mmHg in SBP or 10 mmHg in DBP or a clinical manifestation of postural hypotension.
  11. Chronic use of any drugs (prescription or OTC) within 4 weeks prior to Visit 2 (single use of medication such as paracetamol for headache will be tolerated at the lowest possible dose).
  12. Intake of any Nitric Oxide Synthase Inhibitor within 1 month before Screening visit.
  13. History of drug addiction or alcohol abuse as defined by DSM IVR, diagnostic criteria for drug and alcohol abuse or drug addiction.
  14. Positive drug screening (opiates, cannabinoids, cocaine, benzodiazepines, amphetamines, barbiturates) at the Screening visit.
  15. Current participation or participation within 60 days prior to the Screening visit, in another investigational study, including the present study or any previous enrolment in a naproxcinod study.
  16. In custody due to an administrative or a legal decision, or under tutelage, or being admitted to a sanitary or social institution.
  17. Any direct or indirect involvement with the study conduct or staff at site or any family link with study site staff.
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Responsible Party: NicOx Identifier: NCT00909519    
Other Study ID Numbers: HCT3012-X-113
First Posted: May 28, 2009    Key Record Dates
Last Update Posted: June 17, 2011
Last Verified: June 2011
Additional relevant MeSH terms:
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Naproxen-n-butyl nitrate
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Natriuretic Agents
Sodium Potassium Chloride Symporter Inhibitors
Membrane Transport Modulators
Nitric Oxide Donors