NCT00750243

Brief Summary

The purpose of this study is to compare naproxen plasma levels and gastroduodenal mucosal injury after administration of LT-NS001 as compared to Naprosyn in subjects age 45-70.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Sep 2008

Typical duration for phase_1 healthy

Geographic Reach
1 country

1 active site

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

September 1, 2008

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

September 8, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 10, 2008

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
Last Updated

October 6, 2010

Status Verified

October 1, 2010

Enrollment Period

5 months

First QC Date

September 8, 2008

Last Update Submit

October 4, 2010

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Assessment of GI mucosal injury by endoscopy

    7 days

Secondary Outcomes (1)

  • Comparison of naproxen PK at steady state

    7.5 days

Study Arms (2)

A

EXPERIMENTAL
Drug: LT-NS001

B

ACTIVE COMPARATOR
Drug: Naprosyn®

Interventions

LT-NS001DRUG

1200 mg b.i.d. p.o. for 7.5 days

A
Naprosyn®DRUG

500 mg b.i.d. p.o. for 7.5 days

B

Eligibility Criteria

Age45 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI 18-30 kg/m2
  • No NSAID's for 14 days prior to baseline endoscopy

You may not qualify if:

  • Pregnant/Nursing women
  • History of documented gastroduodenal ulcer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

Related Publications (1)

  • Goldstein JL, Jungwirthova A, David J, Spindel E, Bouchner L, Pesek F, Searle S, Skopek J, Grim J, Ulc I, Sewell KL. Clinical trial: endoscopic evaluation of naproxen etemesil, a naproxen prodrug, vs. naproxen - a proof-of-concept, randomized, double-blind, active-comparator study. Aliment Pharmacol Ther. 2010 Nov;32(9):1091-101. doi: 10.1111/j.1365-2036.2010.04442.x. Epub 2010 Aug 23.

    PMID: 20804454DERIVED

MeSH Terms

Interventions

Naproxen

Intervention Hierarchy (Ancestors)

Naphthaleneacetic AcidsNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 8, 2008

First Posted

September 10, 2008

Study Start

September 1, 2008

Primary Completion

February 1, 2009

Study Completion

April 1, 2009

Last Updated

October 6, 2010

Record last verified: 2010-10

Locations

US(1)