CLINICAL TRIALS PROFILE FOR NAPRELAN

All Clinical Trials for NAPRELAN

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00778193 ↗	Effect of Naproxen, Aspirin, Celecoxib, or Clopidogrel on the Healing of Stomach and Intestinal Ulcers	Completed	Research Associates of New York, LLP	Phase 4	2007-10-01	Gastroduodenal ulcers are extremely common in the community today. Though much has been written and observed concerning how ulcers form, not much has been described in the human model concerning how these ulcers heal. As numerous patients already suffer from gastrointestinal ulcers, further clarification of ulcer healing would be valuable in the treatment and management of these patients. The goal of this study is to investigate the effects of naproxen, aspirin, celecoxib, and clopidogrel on biopsy-induced gastroduodenal lesions in order to elucidate the mechanisms of ulcer healing. This single site, single-blind, randomized, placebo-controlled, one-week prospective study will examine ulcer healing through endoscopic, immunohistologic, and molecular PCR modalities.
NCT00969449 ↗	Pharmacokinetics Study Comparing Naproxen Sodium Extended Release and Naprelan	Completed	Bayer	Phase 1	2009-04-01	To compare the pharmacokinetic profile of the proposed extended- release tablet of naproxen sodium 660 mg relative to two tablets of Naprelan 500 mg following single dose administration for 36 hours under fasted conditions
NCT01442428 ↗	Paradoxical Tuberculosis Immune Reconstitution Inflammatory Syndrome (TB-IRIS) Treatment Trial	Withdrawn	Minnesota Medical Foundation	Phase 2/Phase 3	2014-01-01	Tuberculosis is the most common opportunistic infection (OI) in HIV-infected persons worldwide, including in South East Asia. Significant numbers of patients experience tuberculosis-related paradoxical immune reconstitution inflammatory syndrome (TB-IRIS) after ART initiation, yet the optimal treatment of TB-IRIS is unknown. A recent randomized-controlled trial showed the benefit of prednisone over placebo in reduction of days of hospitalization and invasive procedures. The investigators hypothesize that nonsteroidal anti-inflammatory drugs (NSAIDs) are as effective as corticosteroids for treatment of non-life threatening TB-IRIS in HIV-infected patients and hypothesize that adjunctive treatment with 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors (Statins) may improve the outcomes. This is a randomized controlled trial with a 2x2 factorial design to test the relative benefit of corticosteroids, NSAIDS, and Statins for the symptomatic and immunologic control of TB-IRIS.
NCT01442428 ↗	Paradoxical Tuberculosis Immune Reconstitution Inflammatory Syndrome (TB-IRIS) Treatment Trial	Withdrawn	Pfizer	Phase 2/Phase 3	2014-01-01	Tuberculosis is the most common opportunistic infection (OI) in HIV-infected persons worldwide, including in South East Asia. Significant numbers of patients experience tuberculosis-related paradoxical immune reconstitution inflammatory syndrome (TB-IRIS) after ART initiation, yet the optimal treatment of TB-IRIS is unknown. A recent randomized-controlled trial showed the benefit of prednisone over placebo in reduction of days of hospitalization and invasive procedures. The investigators hypothesize that nonsteroidal anti-inflammatory drugs (NSAIDs) are as effective as corticosteroids for treatment of non-life threatening TB-IRIS in HIV-infected patients and hypothesize that adjunctive treatment with 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors (Statins) may improve the outcomes. This is a randomized controlled trial with a 2x2 factorial design to test the relative benefit of corticosteroids, NSAIDS, and Statins for the symptomatic and immunologic control of TB-IRIS.
NCT01442428 ↗	Paradoxical Tuberculosis Immune Reconstitution Inflammatory Syndrome (TB-IRIS) Treatment Trial	Withdrawn	University of Minnesota	Phase 2/Phase 3	2014-01-01	Tuberculosis is the most common opportunistic infection (OI) in HIV-infected persons worldwide, including in South East Asia. Significant numbers of patients experience tuberculosis-related paradoxical immune reconstitution inflammatory syndrome (TB-IRIS) after ART initiation, yet the optimal treatment of TB-IRIS is unknown. A recent randomized-controlled trial showed the benefit of prednisone over placebo in reduction of days of hospitalization and invasive procedures. The investigators hypothesize that nonsteroidal anti-inflammatory drugs (NSAIDs) are as effective as corticosteroids for treatment of non-life threatening TB-IRIS in HIV-infected patients and hypothesize that adjunctive treatment with 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors (Statins) may improve the outcomes. This is a randomized controlled trial with a 2x2 factorial design to test the relative benefit of corticosteroids, NSAIDS, and Statins for the symptomatic and immunologic control of TB-IRIS.
NCT01442428 ↗	Paradoxical Tuberculosis Immune Reconstitution Inflammatory Syndrome (TB-IRIS) Treatment Trial	Withdrawn	University of Minnesota - Clinical and Translational Science Institute	Phase 2/Phase 3	2014-01-01	Tuberculosis is the most common opportunistic infection (OI) in HIV-infected persons worldwide, including in South East Asia. Significant numbers of patients experience tuberculosis-related paradoxical immune reconstitution inflammatory syndrome (TB-IRIS) after ART initiation, yet the optimal treatment of TB-IRIS is unknown. A recent randomized-controlled trial showed the benefit of prednisone over placebo in reduction of days of hospitalization and invasive procedures. The investigators hypothesize that nonsteroidal anti-inflammatory drugs (NSAIDs) are as effective as corticosteroids for treatment of non-life threatening TB-IRIS in HIV-infected patients and hypothesize that adjunctive treatment with 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors (Statins) may improve the outcomes. This is a randomized controlled trial with a 2x2 factorial design to test the relative benefit of corticosteroids, NSAIDS, and Statins for the symptomatic and immunologic control of TB-IRIS.
NCT01951105 ↗	Effect of L-dopa In Subacute Back Pain Population	Completed	National Institute of Dental and Craniofacial Research (NIDCR)	Phase 4	2015-02-24	This study aims to determine if early treatment with Carbidopa/Levodopa and Naproxen in individuals with sub-acute back pain (SBP) is associated with changes in blocking transition to chronic back pain (CBP).

Clinical Trial Conditions for NAPRELAN

Condition Name

Condition Name for NAPRELAN
Intervention	Trials
Acute Pain	2
Chronic Low Back Pain	2
Sub-acute Back Pain	1
Toe Fusion	1

Condition MeSH

Condition MeSH for NAPRELAN
Intervention	Trials
Back Pain	3
Low Back Pain	2
Acute Pain	2
Acquired Immunodeficiency Syndrome	1

Clinical Trial Locations for NAPRELAN

Trials by Country

Trials by Country for NAPRELAN
Location	Trials
United States	6
Thailand	1

Trials by US State

Trials by US State for NAPRELAN
Location	Trials
Illinois	4
Texas	1
New York	1

Clinical Trial Progress for NAPRELAN

Clinical Trial Phase

Clinical Trial Phase for NAPRELAN
Clinical Trial Phase	Trials
Phase 4	4
Phase 2/Phase 3	1
Phase 2	2

Clinical Trial Status

Clinical Trial Status for NAPRELAN
Clinical Trial Phase	Trials
Completed	4
Withdrawn	2
Not yet recruiting	1

Clinical Trial Sponsors for NAPRELAN

Sponsor Name

Sponsor Name for NAPRELAN
Sponsor	Trials
National Institutes of Health (NIH)	5
Northwestern University	4
National Center for Complementary and Integrative Health (NCCIH)	2

Sponsor Type

Sponsor Type for NAPRELAN
Sponsor	Trials
Other	10
NIH	9
Industry	2