A Double-Blind, Double-Dummy, Randomized, Active-Comparator, Arthritis Non-Inferiority Study of LT-NS001 versus Naprosyn® for Twelve Weeks in Osteoarthritis Patients to Compare Endoscopic Gastric Ulcer Rates - Nature Trial

Start Date26 Apr 2010

Sponsor / Collaborator

Logical Therapeutics, Inc.

NCT01063920 / CompletedPhase 2/3

A Double-Blind, Double-Dummy, Randomized, Active-Comparator, Non-Inferiority Study of LT-NS001 Versus Naprosyn® for Twelve Weeks in Osteoarthritis Patients to Compare Endoscopic Gastric Ulcer Rates

LT-NS001 is a prodrug of Naproxen, which is inactive as a cox inhibitor while intact and is rapidly metabolized to Naproxen once absorbed. This trial will compare the rate of gastric ulcer by endoscopy over three months in patients with knee osteoarthritis, with patients receiving either LT-NS001 at a dose which provides comparable dose levels of Naproxen, or Naprosyn® 500mg (an approved treatment for OA).

Start Date01 Feb 2010

Sponsor / Collaborator

Logical Therapeutics, Inc.

[+1]

NCT00750243 / CompletedPhase 1

A Double-Blind, Randomized, Active Comparator Study of LT-NS001 Versus Naprosyn for Seven Days in Healthy Subjects With Endoscopic Evaluation

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.

Start Date01 Sep 2008

Sponsor / Collaborator

Logical Therapeutics, Inc.

100 Clinical Results associated with Naproxen Etemesil

100 Translational Medicine associated with Naproxen Etemesil

100 Patents (Medical) associated with Naproxen Etemesil

Literatures (Medical) associated with Naproxen Etemesil

01 Nov 2010·Alimentary Pharmacology & TherapeuticsQ1 · MEDICINE

Clinical trial: endoscopic evaluation of naproxen etemesil, a naproxen prodrug, vs. naproxen – a proof‐of‐concept, randomized, double‐blind, active‐comparator study

Q1 · MEDICINE

Article

Author: E. Spindel ; F. Pešek ; J. Grim ; A. Jungwirthová ; K. L. Sewell ; J. Škopek ; L. Bouchner ; J. L. Goldstein ; S. Searle ; I. Ulč ; J. David

Aliment Pharmacol Ther 2010; 32: 1091–1101SummaryBackground Nonsteroidal anti‐inflammatory drugs are associated with upper gastrointestinal mucosal injury. Naproxen etemesil is a lipophilic, non‐acidic, inactive prodrug of naproxen that is hydrolysed to pharmacologically active naproxen once absorbed. We hypothesized that with lesser topical exposure to naproxen from the prodrug, there would be reduced gastroduodenal mucosal injury compared with naproxen.Aim To compare the degree of endoscopic mucosal damage of naproxen etemesil vs. naproxen.Methods This multicentre, randomized, double‐blind, double‐dummy trial compared oral naproxen etemesil 1200 mg twice daily (n = 61) with naproxen 500 mg twice daily (n = 59) for 7.5 days in 120 healthy subjects (45–70 years; mean 51 years; 58% female) with baseline total modified gastroduodenal Lanza score ≤2 (no erosions/ulcers) on endoscopy. The primary endpoint was mean total modified gastroduodenal Lanza score on day 7. A secondary endpoint was incidence of gastric ulcers.Results The day 7 mean total modified gastroduodenal Lanza score was 2.8 ± 1.7 for naproxen etemesil vs. 3.5 ± 2.0 for naproxen (P = 0.03), and significantly fewer naproxen etemesil‐treated subjects (3.3%) developed gastric ulcers compared with naproxen‐treated subjects (15.8%) (P = 0.02).Conclusion In this first proof‐of‐concept study, naproxen etemesil was associated with significantly lower gastroduodenal mucosal injury compared with naproxen after 7 days of exposure (Clinical trial number: NCT00750243).

100 Deals associated with Naproxen Etemesil

External Link

KEGG	Wiki	ATC	Drug Bank
D10017	Naproxen Etemesil	-	DB12398

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Ankylosing Spondylitis	Phase 3	US	Logical Therapeutics, Inc.	10 Aug 2010
Rheumatoid Arthritis	Phase 3	US	Logical Therapeutics, Inc.	10 Aug 2010
Osteoarthritis	Phase 3	US	Logical Therapeutics, Inc.	01 Feb 2010
Osteoarthritis, Knee	Phase 3	US	Logical Therapeutics, Inc.	01 Feb 2010
Stomach Ulcer	Phase 3	US	Logical Therapeutics, Inc.	01 Feb 2010
Gastric mucosal lesion	Phase 3	US	Logical Therapeutics, Inc.	01 Sep 2008

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT00750243 (Pubmed \| Aliment Pharmacol Ther)	Phase 1	Gastric mucosal lesion	120	Naproxen etemesil 1200 mg	aruqxynsae(txuheybftv) = zirmypqjkw btwmyjzfiv (kcnrmlbptt )	Positive	01 Nov 2010
				Naproxen 500 mg	aruqxynsae(txuheybftv) = saugijeuna btwmyjzfiv (kcnrmlbptt )

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