NCT00674856

Brief Summary

To study the pharmacokinetics and safety of naproxcinod in patients with impaired renal function

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started May 2008

Shorter than P25 for phase_1

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2008

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

May 6, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 8, 2008

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
Last Updated

January 28, 2009

Status Verified

January 1, 2009

Enrollment Period

4 months

First QC Date

May 6, 2008

Last Update Submit

January 27, 2009

Conditions

Renal Failure

Outcome Measures

Primary Outcomes (1)

  • To assess differences in the plasma pharmacokinetics profile of naproxcinod and naproxen (total and unbound) between renal impaired patients and healthy subjects.

    8 days

Secondary Outcomes (2)

  • To assess differences in the plasma and urinary pharmacokinetic profile of naproxcinod metabolites between renal impaired patients and healthy subjects.

    8 days

  • To assess the general safety of naproxcinod in renal impaired patients and in healthy subjects as shown by the biological tolerance and the adverse events (AE) profile.

    8 days

Study Arms (1)

naproxcinod

EXPERIMENTAL

naproxcinod 750mg(375mg caps x2), administered twice a day.

Drug: naproxcinod

Interventions

naproxcinodDRUG

750mg

naproxcinod

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female aged 18 to 75 years with stable mild to moderate renal insufficiency.
  • Male or female aged 18 to 75 years with similar distribution of age, weight, gender, smoking habits, and race, and in general good health

You may not qualify if:

  • Any significant acute or chronic disease (except renal impairment) which may interfere with study evaluations.
  • A history of alcohol or drug abuse.
  • Diagnosis of gastric or duodenal ulceration and/or history of significant gastro-duodenal bleeding within the last 6 months
  • Clinically relevant abnormal ECG
  • Current or expected use of anticoagulants or analgesic, anti-inflammatory therapies except low dose aspirin (less than or equal to 325mg per day).
  • Participation within 30 days prior to screening in another investigational study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Unknown Facility

Orlando, Florida, United States

Location

Unknown Facility

Minneapolis, Minnesota, United States

Location

Unknown Facility

Saint Paul, Minnesota, United States

Location

MeSH Terms

Conditions

Renal Insufficiency

Interventions

naproxen-n-butyl nitrate

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 6, 2008

First Posted

May 8, 2008

Study Start

May 1, 2008

Primary Completion

September 1, 2008

Study Completion

October 1, 2008

Last Updated

January 28, 2009

Record last verified: 2009-01

Locations

US(3)