CLINICAL TRIALS PROFILE FOR STERILE WATER FOR IRRIGATION

505(b)(2) Clinical Trials for Sterile Water For Irrigation

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
OTC	NCT06076304 ↗	Nasal Steroids, Irrigation, Oral Antibiotics, and Subgroup Targeting for Effective Management of Sinusitis	Active, not recruiting	Medstar Health Research Institute	Phase 4	2023-11-21	Sinus infections are sometimes treated with antibiotics or nasal sprays, while some patients get better on their own. Some patients may wait a few days or use common over-the-counter remedies to see if their symptoms improve without further treatment. The overall goal of this clinical trial to see which patients with sinus infections are more likely to respond to different treatments, and which improve with supportive care alone.
OTC	NCT06076304 ↗	Nasal Steroids, Irrigation, Oral Antibiotics, and Subgroup Targeting for Effective Management of Sinusitis	Active, not recruiting	Patient-Centered Outcomes Research Institute	Phase 4	2023-11-21	Sinus infections are sometimes treated with antibiotics or nasal sprays, while some patients get better on their own. Some patients may wait a few days or use common over-the-counter remedies to see if their symptoms improve without further treatment. The overall goal of this clinical trial to see which patients with sinus infections are more likely to respond to different treatments, and which improve with supportive care alone.
OTC	NCT06076304 ↗	Nasal Steroids, Irrigation, Oral Antibiotics, and Subgroup Targeting for Effective Management of Sinusitis	Active, not recruiting	Penn State College of Medicine	Phase 4	2023-11-21	Sinus infections are sometimes treated with antibiotics or nasal sprays, while some patients get better on their own. Some patients may wait a few days or use common over-the-counter remedies to see if their symptoms improve without further treatment. The overall goal of this clinical trial to see which patients with sinus infections are more likely to respond to different treatments, and which improve with supportive care alone.
OTC	NCT06076304 ↗	Nasal Steroids, Irrigation, Oral Antibiotics, and Subgroup Targeting for Effective Management of Sinusitis	Active, not recruiting	University of California, Los Angeles	Phase 4	2023-11-21	Sinus infections are sometimes treated with antibiotics or nasal sprays, while some patients get better on their own. Some patients may wait a few days or use common over-the-counter remedies to see if their symptoms improve without further treatment. The overall goal of this clinical trial to see which patients with sinus infections are more likely to respond to different treatments, and which improve with supportive care alone.
OTC	NCT06076304 ↗	Nasal Steroids, Irrigation, Oral Antibiotics, and Subgroup Targeting for Effective Management of Sinusitis	Active, not recruiting	University of Washington	Phase 4	2023-11-21	Sinus infections are sometimes treated with antibiotics or nasal sprays, while some patients get better on their own. Some patients may wait a few days or use common over-the-counter remedies to see if their symptoms improve without further treatment. The overall goal of this clinical trial to see which patients with sinus infections are more likely to respond to different treatments, and which improve with supportive care alone.
OTC	NCT06076304 ↗	Nasal Steroids, Irrigation, Oral Antibiotics, and Subgroup Targeting for Effective Management of Sinusitis	Active, not recruiting	University of Wisconsin, Madison	Phase 4	2023-11-21	Sinus infections are sometimes treated with antibiotics or nasal sprays, while some patients get better on their own. Some patients may wait a few days or use common over-the-counter remedies to see if their symptoms improve without further treatment. The overall goal of this clinical trial to see which patients with sinus infections are more likely to respond to different treatments, and which improve with supportive care alone.
OTC	NCT06076304 ↗	Nasal Steroids, Irrigation, Oral Antibiotics, and Subgroup Targeting for Effective Management of Sinusitis	Active, not recruiting	Virginia Commonwealth University	Phase 4	2023-11-21	Sinus infections are sometimes treated with antibiotics or nasal sprays, while some patients get better on their own. Some patients may wait a few days or use common over-the-counter remedies to see if their symptoms improve without further treatment. The overall goal of this clinical trial to see which patients with sinus infections are more likely to respond to different treatments, and which improve with supportive care alone.

All Clinical Trials for Sterile Water For Irrigation

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00004412 ↗	Phase II Randomized Trial:Arginine Butyrate Plus Standard Local Therapy in Patients With Refractory Sickle Cell Ulcers	Completed	Boston Medical Center	Phase 2	1997-09-01	OBJECTIVES: I. Compare the efficacy of local care alone vs local care plus arginine butyrate in terms of healing rate in patients with refractory sickle cell ulcers. II. Determine the effect of arginine butyrate therapy on tissue factors related to promotion or inhibition of wound healing in these patients. III. Determine whether the regimen used in this study is appropriate for testing in pivotal trials.
NCT00004412 ↗	Phase II Randomized Trial:Arginine Butyrate Plus Standard Local Therapy in Patients With Refractory Sickle Cell Ulcers	Completed	Icahn School of Medicine at Mount Sinai	Phase 2	1997-09-01	OBJECTIVES: I. Compare the efficacy of local care alone vs local care plus arginine butyrate in terms of healing rate in patients with refractory sickle cell ulcers. II. Determine the effect of arginine butyrate therapy on tissue factors related to promotion or inhibition of wound healing in these patients. III. Determine whether the regimen used in this study is appropriate for testing in pivotal trials.
NCT00004412 ↗	Phase II Randomized Trial:Arginine Butyrate Plus Standard Local Therapy in Patients With Refractory Sickle Cell Ulcers	Completed	Schneider Children's Medical Center, Israel	Phase 2	1997-09-01	OBJECTIVES: I. Compare the efficacy of local care alone vs local care plus arginine butyrate in terms of healing rate in patients with refractory sickle cell ulcers. II. Determine the effect of arginine butyrate therapy on tissue factors related to promotion or inhibition of wound healing in these patients. III. Determine whether the regimen used in this study is appropriate for testing in pivotal trials.
NCT00004412 ↗	Phase II Randomized Trial:Arginine Butyrate Plus Standard Local Therapy in Patients With Refractory Sickle Cell Ulcers	Completed	University of Illinois at Chicago	Phase 2	1997-09-01	OBJECTIVES: I. Compare the efficacy of local care alone vs local care plus arginine butyrate in terms of healing rate in patients with refractory sickle cell ulcers. II. Determine the effect of arginine butyrate therapy on tissue factors related to promotion or inhibition of wound healing in these patients. III. Determine whether the regimen used in this study is appropriate for testing in pivotal trials.
NCT00004412 ↗	Phase II Randomized Trial:Arginine Butyrate Plus Standard Local Therapy in Patients With Refractory Sickle Cell Ulcers	Completed	University of Tennessee Health Science Center	Phase 2	1997-09-01	OBJECTIVES: I. Compare the efficacy of local care alone vs local care plus arginine butyrate in terms of healing rate in patients with refractory sickle cell ulcers. II. Determine the effect of arginine butyrate therapy on tissue factors related to promotion or inhibition of wound healing in these patients. III. Determine whether the regimen used in this study is appropriate for testing in pivotal trials.
NCT00004412 ↗	Phase II Randomized Trial:Arginine Butyrate Plus Standard Local Therapy in Patients With Refractory Sickle Cell Ulcers	Completed	Susan P. Perrine	Phase 2	1997-09-01	OBJECTIVES: I. Compare the efficacy of local care alone vs local care plus arginine butyrate in terms of healing rate in patients with refractory sickle cell ulcers. II. Determine the effect of arginine butyrate therapy on tissue factors related to promotion or inhibition of wound healing in these patients. III. Determine whether the regimen used in this study is appropriate for testing in pivotal trials.
NCT00278512 ↗	Hematopoietic Stem Cell Support in Vasculitis	Terminated	Northwestern University	Phase 1	2003-08-01	The systemic vasculitis is a wide-ranging group of diseases that are characterized by the presence of blood vessel inflammation (1). Despite this common feature, each type of vasculitis has a unique variety of clinical manifestations that influences its degree of disease severity and ultimately its management. Immunosuppressive therapy forms the foundation of treatment for almost all forms of systemic vasculitis. The systemic necrotizing vasculitis (SNV) are a subset of vasculitis with significant morbidity and mortality (2). The SNV are Wegener's granulomatosis, allergic angiitis and granulomatosis (AAG) (also known as Churg-Strauss syndrome), polyarteritis nodosum (PAN), microscopic polyangiitis (MPA), and overlap syndrome. In spite of modern therapeutic immune suppressive agents, there remains a not inconsequential morbidity and mortality associated with SNV. The current standard therapy for SNV is chronic oral cyclophosphamide (1-3 mg/kg/day) and corticosteroids (3-6). Transplant doses of cyclophosphamide at 200 mg/kg infused over 4 days is the most common worldwide transplant regimen for systemic lupus erythematosus (SLE) (7). Like SLE, SNV are cyclophosphamide responsive disease. We, therefore, propose a trial of high dose cyclophosphamide with anti-thymocyte globulin (ATG) for patients with SNV.

Clinical Trial Conditions for Sterile Water For Irrigation

Condition Name

Condition Name for Sterile Water For Irrigation
Intervention	Trials
Sinusitis	11
Surgical Site Infection	10
Chronic Rhinosinusitis (Diagnosis)	8
Postoperative Pain	8

Condition MeSH

Condition MeSH for Sterile Water For Irrigation
Intervention	Trials
Infections	34
Sinusitis	30
Infection	27
Pain, Postoperative	23

Clinical Trial Locations for Sterile Water For Irrigation

Trials by Country

Trials by Country for Sterile Water For Irrigation
Location	Trials
United States	193
Egypt	29
Canada	21
Taiwan	10
China	8

Trials by US State

Trials by US State for Sterile Water For Irrigation
Location	Trials
Texas	19
California	17
Missouri	13
Pennsylvania	13
New York	10

Clinical Trial Progress for Sterile Water For Irrigation

Clinical Trial Phase

Clinical Trial Phase for Sterile Water For Irrigation
Clinical Trial Phase	Trials
Phase 4	89
Phase 3	37
Phase 2/Phase 3	14

Clinical Trial Status

Clinical Trial Status for Sterile Water For Irrigation
Clinical Trial Phase	Trials
Completed	127
Not yet recruiting	48
Unknown status	48

Clinical Trial Sponsors for Sterile Water For Irrigation

Sponsor Name

Sponsor Name for Sterile Water For Irrigation
Sponsor	Trials
Cairo University	19
Washington University School of Medicine	8
Ain Shams University	6

Sponsor Type

Sponsor Type for Sterile Water For Irrigation
Sponsor	Trials
Other	407
Industry	37
U.S. Fed	6