A Phase II Study to Determine the Efficacy and Safety of Sivelestat in Subjects With Acute Lung Injury

Sponsor

Eli Lilly and Company (Industry)

Overall Status

Completed

CT.gov ID

NCT00036062

Collaborator

(none)

600

Enrollment

110

Locations

Duration (Months)

5.5

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine whether sivelestat will reduce the amount of time a patient must spend on a ventilator and/or increase the chance of survival of patients with acute lung injury.

Condition or Disease	Intervention/Treatment	Phase
Respiratory Distress Syndrome, Adult Acute Lung Injury	Drug: Sivelestat	Phase 1/Phase 2

Detailed Description

Acute lung injury often develops as a result of severe infection, sepsis, severe injuries, inhalation of foreign substances into the lungs, or pneumonia. The tissues and blood vessels in the lungs become inflamed, and the body does not receive enough oxygen. Patients with this condition are placed on a ventilator to assist with breathing.

Patients entered into this study will be randomly assigned to one of two treatment groups: a sivelestat group or a placebo group. Once entered into the study, patients are monitored for up to 6 months.

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

A Phase II Study to Determine the Efficacy and Safety of Sivelestat in Subjects With Acute Lung Injury

Study Start Date :

Aug 1, 2001

Study Completion Date :

Dec 1, 2002

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria

show evidence of acute lung injury
be on mechanical ventilation

Exclusion Criteria

have undergone certain organ transplants
have severe underlying medical problems
be unlikely to survive
be pregnant or breast-feeding

Contacts and Locations

Locations

	City	State	Country
1	Birmingham	Alabama	United States
2	Phoenix	Arizona	United States
3	Tucson	Arizona	United States
4	Orange	California	United States
5	Sacramento	California	United States
6	San Diego	California	United States
7	Denver	Colorado	United States
8	Englewood	Colorado	United States
9	New Haven	Connecticut	United States
10	Washington	District of Columbia	United States
11	Bay Pines	Florida	United States
12	Clearwater	Florida	United States
13	Ft. Lauderdale	Florida	United States
14	Augusta	Georgia	United States
15	Austell	Georgia	United States
16	Chicago	Illinois	United States
17	Elk Grove Village	Illinois	United States
18	Maywood	Illinois	United States
19	North Chicago	Illinois	United States
20	Indianapolis	Indiana	United States
21	Des Moines	Iowa	United States
22	Kansas City	Kansas	United States
23	Lexington	Kentucky	United States
24	Louisville	Kentucky	United States
25	Baton Rouge	Louisiana	United States
26	Lake Charles	Louisiana	United States
27	Shreveport	Louisiana	United States
28	Portland	Maine	United States
29	Baltimore	Maryland	United States
30	Silver Spring	Maryland	United States
31	Towson	Maryland	United States
32	Boston	Massachusetts	United States
33	Detroit	Michigan	United States
34	Kalamazoo	Michigan	United States
35	St. Louis	Missouri	United States
36	Camden	New Jersey	United States
37	Hackensack	New Jersey	United States
38	Holmdel	New Jersey	United States
39	Bronx	New York	United States
40	Buffalo	New York	United States
41	Elmhurst	New York	United States
42	Manhasset	New York	United States
43	Mineola	New York	United States
44	New York	New York	United States
45	Rochester	New York	United States
46	Greensboro	North Carolina	United States
47	Winston-Salem	North Carolina	United States
48	Akron	Ohio	United States
49	Cincinnati	Ohio	United States
50	Toledo	Ohio	United States
51	Portland	Oregon	United States
52	Allentown	Pennsylvania	United States
53	Hershey	Pennsylvania	United States
54	Philadelphia	Pennsylvania	United States
55	Pittsburgh	Pennsylvania	United States
56	Providence	Rhode Island	United States
57	Sioux Falls	South Dakota	United States
58	Memphis	Tennessee	United States
59	Nashville	Tennessee	United States
60	Houston	Texas	United States
61	Irving	Texas	United States
62	Lubbock	Texas	United States
63	San Antonio	Texas	United States
64	Newport News	Virginia	United States
65	Morgantown	West Virginia	United States
66	Garran	Australian Capital Territory	Australia
67	Camperdown	New South Wales	Australia
68	Kingswood	New South Wales	Australia
69	Kogarah	New South Wales	Australia
70	St. Leonards	New South Wales	Australia
71	Wentworthville	New South Wales	Australia
72	SouthPort	Queensland	Australia
73	Adelaide	South Australia	Australia
74	Bedford Park	South Australia	Australia
75	Woodville	South Australia	Australia
76	Heidelberg	Victoria	Australia
77	Parkville	Victoria	Australia
78	Prahran	Victoria	Australia
79	Fremantle	Western Australia	Australia
80	Perth	Western Australia	Australia
81	Aaist		Belgium
82	Antwerpen		Belgium
83	Arion		Belgium
84	Braine L' Alleud		Belgium
85	Brugge		Belgium
86	Brussels		Belgium
87	Gent		Belgium
88	Liege		Belgium
89	Edmonton	Alberta	Canada
90	Vancouver	British Columbia	Canada
91	Winnipeg	Manitoba	Canada
92	Halifax	Nova Scotia	Canada
93	Hamilton	Ontario	Canada
94	Toronto	Ontario	Canada
95	Windsor	Ontario	Canada
96	Montreal	Quebec	Canada
97	Sherbrooke	Quebec	Canada
98	Christchurch	Canterbury	New Zealand
99	Auckland		New Zealand
100	Hastings		New Zealand
101	Wellington		New Zealand
102	Manresa	Barcelona	Spain
103	Sabadell	Barcelona	Spain
104	Getafe	Madrid	Spain
105	El Palmar	Murcia	Spain
106	Badajoz		Spain
107	Barcelona		Spain
108	Madrid		Spain
109	Murcia		Spain
110	Palma De Mallorca		Spain