A Study Comparing the Efficacy and Safety of Valdecoxib Plus Parecoxib Versus Valdecoxib Plus Placebo for the Treatment of Pain After Coronary Artery Bypass Surgery

Sponsor

Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT00636064

Collaborator

(none)

1,671

Enrollment

207

Locations

Arms

Duration (Months)

8.1

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of parecoxib/valdecoxib therapy and placebo/valdecoxib therapy for the treatment of pain after coronary artery bypass surgery

Condition or Disease	Intervention/Treatment	Phase
Pain	Drug: Parecoxib Sodium/Valdecoxib Drug: Placebo/Valdecoxib Other: Placebo/Placebo	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

1671 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

A Double-Blind Multicenter Study of the Safety and Efficacy of Parecoxib Sodium/Valdecoxib and Placebo/Valdecoxib Compared to Placebo for Treatment of Post-Surgical Pain in Patients Who Have Coronary Bypass Graft Via Median Sternotomy

Study Start Date :

Jan 1, 2003

Actual Study Completion Date :

Jan 1, 2004

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: A	Drug: Parecoxib Sodium/Valdecoxib Parecoxib sodium 40 mg intravenous (IV) on the day after surgery (Day 1) following recovery from anesthesia, contingent on an acceptable postoperative status, verification of baseline eligibility, and lack of perioperative complications. A second dose of parecoxib sodium 20 mg IV was administered on Day 1. On the day following surgery, patients received parecoxib 20 mg IV at 8 am and each subsequent dose was administered at 12-hour intervals. After receiving at least 6 doses of IV parecoxib sodium, patients were transitioned to oral valdecoxib 20 mg taken at 12-hour intervals until the total treatment duration of 10 days had been completed.
Experimental: B	Drug: Placebo/Valdecoxib Patients received placebo matched to parecoxib sodium 40 mg IV on Day 1 following recovery from anesthesia, contingent on an acceptable postoperative status, verification of baseline eligibility, and lack of perioperative complications. A second dose of placebo matched to parecoxib sodium 20 mg IV was administered on Day 1. On the day following surgery, patients received placebo matched to parecoxib sodium 20 mg IV at 8 am and each subsequent dose was administered at 12-hour intervals. After receiving at least 6 doses of IV placebo, patients were transitioned to oral valdecoxib 20 mg taken at 12-hour intervals until the total treatment duration of 10 days had been completed.
Experimental: C	Other: Placebo/Placebo Patients received placebo matched to parecoxib sodium 40 mg IV on Day 1 following recovery from anesthesia, contingent on an acceptable postoperative status, verification of baseline eligibility, and lack of perioperative complications. A second dose of placebo matched to parecoxib sodium 20 mg IV was administered on Day 1. On the day following surgery, patients received placebo matched to parecoxib sodium 20 mg IV at 8 am and each subsequent dose was administered at 12-hour intervals. After receiving at least 6 doses of IV placebo, patients were transitioned to oral placebo matched to valdecoxib 20 mg taken at 12-hour intervals until the total treatment duration of 10 days had been completed.

Arm

Intervention/Treatment

Placebo Comparator: A

Drug: Parecoxib Sodium/Valdecoxib

Parecoxib sodium 40 mg intravenous (IV) on the day after surgery (Day 1) following recovery from anesthesia, contingent on an acceptable postoperative status, verification of baseline eligibility, and lack of perioperative complications. A second dose of parecoxib sodium 20 mg IV was administered on Day 1. On the day following surgery, patients received parecoxib 20 mg IV at 8 am and each subsequent dose was administered at 12-hour intervals. After receiving at least 6 doses of IV parecoxib sodium, patients were transitioned to oral valdecoxib 20 mg taken at 12-hour intervals until the total treatment duration of 10 days had been completed.

Experimental: B

Drug: Placebo/Valdecoxib

Patients received placebo matched to parecoxib sodium 40 mg IV on Day 1 following recovery from anesthesia, contingent on an acceptable postoperative status, verification of baseline eligibility, and lack of perioperative complications. A second dose of placebo matched to parecoxib sodium 20 mg IV was administered on Day 1. On the day following surgery, patients received placebo matched to parecoxib sodium 20 mg IV at 8 am and each subsequent dose was administered at 12-hour intervals. After receiving at least 6 doses of IV placebo, patients were transitioned to oral valdecoxib 20 mg taken at 12-hour intervals until the total treatment duration of 10 days had been completed.

Experimental: C

Other: Placebo/Placebo

Patients received placebo matched to parecoxib sodium 40 mg IV on Day 1 following recovery from anesthesia, contingent on an acceptable postoperative status, verification of baseline eligibility, and lack of perioperative complications. A second dose of placebo matched to parecoxib sodium 20 mg IV was administered on Day 1. On the day following surgery, patients received placebo matched to parecoxib sodium 20 mg IV at 8 am and each subsequent dose was administered at 12-hour intervals. After receiving at least 6 doses of IV placebo, patients were transitioned to oral placebo matched to valdecoxib 20 mg taken at 12-hour intervals until the total treatment duration of 10 days had been completed.

Outcome Measures

Primary Outcome Measures

Combined incidence of the number of patients with at least 1 confirmed clinically relevant adverse event (CRAE) [Day 30]

Secondary Outcome Measures

Combined incidence of the number of patients with at least 1 reported CRAE and the combined incidence of the number of patients with specific reported CRAEs summarized according to the categories listed above [Day 30]
Rate of supplemental analgesia consumed [Days 1-10]
Vital signs [Day 30]
Summed Pain Intensity (SPI) of sternotomy alone and overall body pain over 8 hours (SPI 8) [Day 1]
Opioid-related Symptoms Distress Scale (OR-SDS) [Days 1-10]
Time to last Patient Controlled Analgesia (PCA) dose []
Recovery measures (length of stay, intensive care unit/hospital recovery and eligibility for discharge) []
Combined incidence of the number of patients with specific confirmed CRAEs in categories of cardiovascular thromboembolic CRAEs, renal CRAEs, upper gastrointestinal ulcer CRAEs, and wound healing complication CRAEs [Day 30]
Adverse events [Day 30]
Serious adverse events [Day 30]
Clinical laboratory assessments [Day 30]
Peak Pain Intensity (PPI) of sternotomy alone and overall body pain [Days 1-10]
Patient's and Physician's Global Evaluation of Study Medication [At time of transition from intravenous to oral medication and final visit/early termination]
Modified Brief Pain Inventory-short form (mBPI-sf) [Days 1-10]
SPI of sternotomy alone and overall body pain over 12 hours (SPI 12) and 24 hours (SPI 24) [Days 1-10]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion criteria:

Patients expected to receive in-hospital pain medication for pain after coronary artery bypass graft surgery for at least 3 full days and pain medication over a 10-day period
New York Heart Association Class I to III or cardiac ejection fraction of at least 35% before surgery
Body mass index of less than or equal to 40 kg/m2 and weight of >55 kg
Patients scheduled to undergo an isolated (bypass grafting only without valve replacement, significant aortic reconstruction, or ventriculoplasty) primary CABG surgery via median sternotomy, using cardiopulmonary bypass

Exclusion criteria:

Patient has undergone or is going to have emergency coronary artery bypass graft surgery or surgery without cardiopulmonary bypass procedure
Symptomatic peripheral vascular disease
Heart attack within 48 hours of surgery

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Fairhope	Alabama	United States	36532
2	Pfizer Investigational Site	Mobile	Alabama	United States	36602
3	Pfizer Investigational Site	Mobile	Alabama	United States	36604
4	Pfizer Investigational Site	Mobile	Alabama	United States	36607
5	Pfizer Investigational Site	Mobile	Alabama	United States	36608
6	Pfizer Investigational Site	Tucson	Arizona	United States	85724
7	Pfizer Investigational Site	Fayetteville	Arkansas	United States	72703
8	Pfizer Investigational Site	Springdale	Arkansas	United States	72764
9	Pfizer Investigational Site	Anaheim	California	United States	92801
10	Pfizer Investigational Site	Anaheim	California	United States	92805
11	Pfizer Investigational Site	Los Angeles	California	United States	90033
12	Pfizer Investigational Site	Los Angeles	California	United States	90095-1778
13	Pfizer Investigational Site	Orange	California	United States	92868
14	Pfizer Investigational Site	Sacramento	California	United States	95819
15	Pfizer Investigational Site	Sacramento	California	United States	95825
16	Pfizer Investigational Site	San Francisco	California	United States	94115
17	Pfizer Investigational Site	San Francisco	California	United States	94118-3110
18	Pfizer Investigational Site	San Francisco	California	United States	94143-0648
19	Pfizer Investigational Site	Santa Rosa	California	United States	95403
20	Pfizer Investigational Site	Santa Rosa	California	United States	95404
21	Pfizer Investigational Site	Stanford	California	United States	94305
22	Pfizer Investigational Site	Fort Collins	Colorado	United States	80524
23	Pfizer Investigational Site	Fort Collins	Colorado	United States	80528
24	Pfizer Investigational Site	New Haven	Connecticut	United States	06504
25	Pfizer Investigational Site	New Haven	Connecticut	United States	06520
26	Pfizer Investigational Site	Washington	District of Columbia	United States	20010
27	Pfizer Investigational Site	Brandon	Florida	United States	33511
28	Pfizer Investigational Site	Clearwater	Florida	United States	33756
29	Pfizer Investigational Site	Hudson	Florida	United States	34667
30	Pfizer Investigational Site	Jacksonville	Florida	United States	32216
31	Pfizer Investigational Site	Melbourne	Florida	United States	32901-3276
32	Pfizer Investigational Site	Melbourne	Florida	United States	32901
33	Pfizer Investigational Site	Pensacola	Florida	United States	32504
34	Pfizer Investigational Site	Pensacola	Florida	United States	32514
35	Pfizer Investigational Site	Sarasota	Florida	United States	34239
36	Pfizer Investigational Site	St. Petersburg	Florida	United States	33709
37	Pfizer Investigational Site	Tampa	Florida	United States	33613
38	Pfizer Investigational Site	Atlanta	Georgia	United States	30322
39	Pfizer Investigational Site	Augusta	Georgia	United States	30901
40	Pfizer Investigational Site	Fort Wayne	Indiana	United States	46804
41	Pfizer Investigational Site	Iowa City	Iowa	United States	52242
42	Pfizer Investigational Site	Kansas City	Kansas	United States	66160
43	Pfizer Investigational Site	Baltimore	Maryland	United States	21215
44	Pfizer Investigational Site	Salisbury	Maryland	United States	21801
45	Pfizer Investigational Site	Takoma Park	Maryland	United States	20912
46	Pfizer Investigational Site	Towson	Maryland	United States	21204
47	Pfizer Investigational Site	Boston	Massachusetts	United States	02215
48	Pfizer Investigational Site	Cambridge	Massachusetts	United States	02138
49	Pfizer Investigational Site	Detroit	Michigan	United States	48202
50	Pfizer Investigational Site	Livonia	Michigan	United States	48150
51	Pfizer Investigational Site	Muskegon	Michigan	United States	49444
52	Pfizer Investigational Site	Royal Oak	Michigan	United States	48073
53	Pfizer Investigational Site	New York	New York	United States	10029
54	Pfizer Investigational Site	Rochester	New York	United States	14621
55	Pfizer Investigational Site	Cincinnati	Ohio	United States	45219
56	Pfizer Investigational Site	Cincinnati	Ohio	United States	45236
57	Pfizer Investigational Site	Dayton	Ohio	United States	45408
58	Pfizer Investigational Site	Dayton	Ohio	United States	45414
59	Pfizer Investigational Site	Sandusky	Ohio	United States	44870
60	Pfizer Investigational Site	Oklahoma City	Oklahoma	United States	73112
61	Pfizer Investigational Site	Tulsa	Oklahoma	United States	74104
62	Pfizer Investigational Site	Portland	Oregon	United States	97210
63	Pfizer Investigational Site	Altoona	Pennsylvania	United States	16601
64	Pfizer Investigational Site	Pittsburgh	Pennsylvania	United States	15212
65	Pfizer Investigational Site	Pittsburgh	Pennsylvania	United States	15224
66	Pfizer Investigational Site	Charleston	South Carolina	United States	29401
67	Pfizer Investigational Site	Charleston	South Carolina	United States	29406
68	Pfizer Investigational Site	Charleston	South Carolina	United States	29424
69	Pfizer Investigational Site	Charleston	South Carolina	United States	29425
70	Pfizer Investigational Site	Memphis	Tennessee	United States	38120
71	Pfizer Investigational Site	Amarillo	Texas	United States	79106
72	Pfizer Investigational Site	Fort Worth	Texas	United States	76107-2699
73	Pfizer Investigational Site	Fort Worth	Texas	United States	76107
74	Pfizer Investigational Site	Houston	Texas	United States	77030
75	Pfizer Investigational Site	Irving	Texas	United States	75061
76	Pfizer Investigational Site	Burlington	Vermont	United States	05401
77	Pfizer Investigational Site	Annandale	Virginia	United States	22003
78	Pfizer Investigational Site	Falls Church	Virginia	United States	22042
79	Pfizer Investigational Site	Fredericksburg	Virginia	United States	22401
80	Pfizer Investigational Site	Norfolk	Virginia	United States	23507
81	Pfizer Investigational Site	Tacoma	Washington	United States	98405
82	Pfizer Investigational Site	Elkhorn	Wisconsin	United States	53121
83	Pfizer Investigational Site	Madison	Wisconsin	United States	53792
84	Pfizer Investigational Site	Milwaukee	Wisconsin	United States	53215
85	Pfizer Investigational Site	Morón	Pcia. de Buenos Aires	Argentina	1708
86	Pfizer Investigational Site	Buenos Aires		Argentina	1118
87	Pfizer Investigational Site	Buenos Aires		Argentina	1416
88	Pfizer Investigational Site	Buenos Aires		Argentina	C1405DCS
89	Pfizer Investigational Site	Auchenflower	Queensland	Australia	4066
90	Pfizer Investigational Site	Ashford	South Australia	Australia	5035
91	Pfizer Investigational Site	Clayton	Victoria	Australia	3168
92	Pfizer Investigational Site	Graz		Austria	8036
93	Pfizer Investigational Site	Brussel		Belgium	1090
94	Pfizer Investigational Site	Bruxelles		Belgium	1070
95	Pfizer Investigational Site	Edegem		Belgium	2650
96	Pfizer Investigational Site	Genk		Belgium	3600
97	Pfizer Investigational Site	Liege		Belgium	B-4000
98	Pfizer Investigational Site	Edmonton	Alberta	Canada	T6G 2B7
99	Pfizer Investigational Site	Vancouver	British Columbia	Canada	V5Z 1M9
100	Pfizer Investigational Site	Vancouver	British Columbia	Canada	V6Z 1Y6
101	Pfizer Investigational Site	Winnipeg	Manitoba	Canada	R3A 1R9
102	Pfizer Investigational Site	Halifax	Nova Scotia	Canada	B3H 3A7
103	Pfizer Investigational Site	Kingston	Ontario	Canada	K7L 2V7
104	Pfizer Investigational Site	Kingston	Ontario	Canada	K7L 5G2
105	Pfizer Investigational Site	London	Ontario	Canada	N6A 5A5
106	Pfizer Investigational Site	Toronto	Ontario	Canada	M4N 3M5
107	Pfizer Investigational Site	Toronto	Ontario	Canada	M5G 2C4
108	Pfizer Investigational Site	Fleurimont	Quebec	Canada	J1H 5N4
109	Pfizer Investigational Site	Montreal	Quebec	Canada	H1T 1C8
110	Pfizer Investigational Site	Montreal	Quebec	Canada	H3A 1A1
111	Pfizer Investigational Site	Regina	Saskatchewan	Canada	S4P 0W5
112	Pfizer Investigational Site	Saskatoon	Saskatchewan	Canada	S7N 0W8
113	Pfizer Investigational Site	Bogota	Cundinamarca	Colombia	000
114	Pfizer Investigational Site	Floridablanca	Santander	Colombia	000
115	Pfizer Investigational Site	Cali	Valle	Colombia	Nap
116	Pfizer Investigational Site	Bogota		Colombia
117	Pfizer Investigational Site	Ceske Budejovice		Czech Republic	370 87
118	Pfizer Investigational Site	Prague 5		Czech Republic	15500
119	Pfizer Investigational Site	Prague		Czech Republic	100 34
120	Pfizer Investigational Site	Prague		Czech Republic	128 00
121	Pfizer Investigational Site	Prague		Czech Republic	14220
122	Pfizer Investigational Site	Prague		Czech Republic	150 00
123	Pfizer Investigational Site	Kobenhavn		Denmark	2100
124	Pfizer Investigational Site	Odense C		Denmark	5000
125	Pfizer Investigational Site	Kuopio		Finland	70211
126	Pfizer Investigational Site	Kuopio		Finland
127	Pfizer Investigational Site	Oulu		Finland
128	Pfizer Investigational Site	Turku		Finland	FIN-20520
129	Pfizer Investigational Site	Aachen		Germany	52074
130	Pfizer Investigational Site	Bonn		Germany	53105
131	Pfizer Investigational Site	Giessen		Germany	35385
132	Pfizer Investigational Site	Goettingen		Germany	37075
133	Pfizer Investigational Site	Hamburg		Germany	20251
134	Pfizer Investigational Site	Heidelberg		Germany	69120
135	Pfizer Investigational Site	Kassel		Germany	34125
136	Pfizer Investigational Site	Kiel		Germany	24105
137	Pfizer Investigational Site	Muenchen		Germany	81377
138	Pfizer Investigational Site	Muenster		Germany	48149
139	Pfizer Investigational Site	Dublin		Ireland
140	Pfizer Investigational Site	Beer Sheva		Israel
141	Pfizer Investigational Site	Haifa		Israel	34362
142	Pfizer Investigational Site	Haifa		Israel
143	Pfizer Investigational Site	Holon		Israel	58100
144	Pfizer Investigational Site	Jerusalem		Israel	91004
145	Pfizer Investigational Site	Jerusalem		Israel	91031
146	Pfizer Investigational Site	Jerusalem		Israel	91120
147	Pfizer Investigational Site	Petach-Tikva		Israel	49261
148	Pfizer Investigational Site	Ramat-Gan		Israel
149	Pfizer Investigational Site	Rehovot		Israel
150	Pfizer Investigational Site	Tel Aviv		Israel
151	Pfizer Investigational Site	Tel Hashomer		Israel	52651
152	Pfizer Investigational Site	Firenze		Italy	50134
153	Pfizer Investigational Site	Milano		Italy	20138
154	Pfizer Investigational Site	Pavia		Italy	27100
155	Pfizer Investigational Site	Pisa		Italy	56125
156	Pfizer Investigational Site	Mexico City	DF	Mexico	03100
157	Pfizer Investigational Site	Mexico City	DF	Mexico	06720
158	Pfizer Investigational Site	Mexico City	DF	Mexico	14050
159	Pfizer Investigational Site	Mexico City	Mexico DF	Mexico	07760
160	Pfizer Investigational Site	Mexico City	Mexico, DF	Mexico	14000
161	Pfizer Investigational Site	Breda		Netherlands	4836 AE
162	Pfizer Investigational Site	Eindhoven		Netherlands	5623 EJ
163	Pfizer Investigational Site	Zwolle		Netherlands	8011 JW
164	Pfizer Investigational Site	Feiring		Norway	2093
165	Pfizer Investigational Site	Bialystok		Poland	15-276
166	Pfizer Investigational Site	Krakow		Poland	31-202
167	Pfizer Investigational Site	Poznan		Poland	61-848
168	Pfizer Investigational Site	Szczecin		Poland	70-111
169	Pfizer Investigational Site	Warszawa		Poland	02-097
170	Pfizer Investigational Site	Bucharest		Romania	7000
171	Pfizer Investigational Site	Bucharest		Romania	771181
172	Pfizer Investigational Site	Bucuresti		Romania	7000
173	Pfizer Investigational Site	Bucuresti		Romania	71406
174	Pfizer Investigational Site	Cluj-Napoca		Romania	3400
175	Pfizer Investigational Site	Timisoara		Romania	1900
176	Pfizer Investigational Site	Moscow		Russian Federation	119992
177	Pfizer Investigational Site	Moscow		Russian Federation	123182
178	Pfizer Investigational Site	Singapore		Singapore	168752
179	Pfizer Investigational Site	Bratislava		Slovakia	833 48
180	Pfizer Investigational Site	Kosice		Slovakia	040-11
181	Pfizer Investigational Site	Bloemfontein	Free State	South Africa
182	Pfizer Investigational Site	Johannesburg	Gauteng Province	South Africa
183	Pfizer Investigational Site	Pretoria	Gauteng Province	South Africa	0140
184	Pfizer Investigational Site	Pretoria	Gauteng	South Africa	0002
185	Pfizer Investigational Site	Pretoria	Gauteng	South Africa	0084
186	Pfizer Investigational Site	Pretoria	Gauteng	South Africa
187	Pfizer Investigational Site	Durban	KwaZulu Natal	South Africa
188	Pfizer Investigational Site	Les Marais	Pretoria	South Africa	0084
189	Pfizer Investigational Site	Parow	Western Cape	South Africa	7500
190	Pfizer Investigational Site	Bloemfontein		South Africa	9300
191	Pfizer Investigational Site	Pretoria		South Africa	0002
192	Pfizer Investigational Site	Pretoria		South Africa	0040
193	Pfizer Investigational Site	Barcelona		Spain	08025
194	Pfizer Investigational Site	Barcelona		Spain	08907
195	Pfizer Investigational Site	Madrid		Spain	28046
196	Pfizer Investigational Site	Valencia		Spain	46010
197	Pfizer Investigational Site	Orebro		Sweden	SE-701 85
198	Pfizer Investigational Site	Stockholm		Sweden	171 76
199	Pfizer Investigational Site	Uppsala		Sweden	SE 751 85
200	Pfizer Investigational Site	Bern		Switzerland	3010
201	Pfizer Investigational Site	Geneve 14		Switzerland	1211
202	Pfizer Investigational Site	Edinburgh		United Kingdom	Eh3 9YW
203	Pfizer Investigational Site	Liverpool		United Kingdom
204	Pfizer Investigational Site	London		United Kingdom	E2 9JX
205	Pfizer Investigational Site	London		United Kingdom	SE1 7EH
206	Pfizer Investigational Site	Middlesbrough		United Kingdom	TS4 3BW
207	Pfizer Investigational Site	Oxford		United Kingdom	OX3 9DU

Sponsors and Collaborators

Pfizer

Investigators

Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

To obtain contact information for a study center near you, click here.

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00636064

Other Study ID Numbers:

PARA-0505-071
A3481015

First Posted:

Mar 14, 2008

Last Update Posted:

Oct 10, 2008

Last Verified:

Mar 1, 2008

Additional relevant MeSH terms:

Parecoxib

Valdecoxib

Study Results

No Results Posted as of Oct 10, 2008