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A Randomized, Double-Blind Study of the Efficacy and Safety of Valdecoxib Compared to Placebo for Treatment of Post- Cholecystectomy Surgery Pain

Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT00661635
Collaborator
(none)
490
Enrollment
65
Locations
3
Arms
8
Duration (Months)
7.5
Patients Per Site
0.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To evaluate the analgesic efficacy, general safety, and effects on health outcome measures and opioid-related symptoms of 2 valdecoxib dosing regimens compared with placebo in patients with moderate or severe pain following laparoscopic cholecystectomy surgery.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
490 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Multiple-Dose, Randomized, Double-Blind, Placebo-Controlled Study of the Analgesic Efficacy and Safety of Valdecoxib Compared to Placebo in Patients for Treatment of Post-Surgical Pain From Laparoscopic Cholecystectomy Surgery
Study Start Date :
Nov 1, 2002
Actual Study Completion Date :
Jul 1, 2003

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Arm 1

Drug: valdecoxib
valdecoxib 40 mg by mouth within 8 hours after the end of surgery, followed by a second dose of valdecoxib 20 mg within 1 to 12 hours (or by midnight on the Day 1, whichever was earlier); then, valdecoxib 20 mg twice daily (BID) on Days 2 to 5.
Active Comparator: Arm 2

Drug: valdecoxib
valdecoxib 40 mg by mouth within 8 hours after the end of surgery, followed by a second dose of valdecoxib 20 mg within 1 to 12 hours (or by midnight on the Day 1, whichever was earlier); then, valdecoxib 20 mg once daily (QD)on Days 2 to 5.
Placebo Comparator: Arm 3

Drug: placebo
valdecoxib 40 mg by mouth within 8 hours after the end of surgery, followed by a second dose of valdecoxib 20 mg within 1 to 12 hours (or by midnight on the Day 1, whichever was earlier); then, placebo twice daily (BID) on Days 2 to 5

Outcome Measures

Primary Outcome Measures

  1. Patient's Global Evaluation of Study Medication [Day 2 and Day 3]

  2. Summed Pain Intensity (categorical) through 24 hours (SPI 24) [Day 2 and Day 3]

Secondary Outcome Measures

  1. Time-specific PI (VAS) [Days 2 to 5]

  2. Patient's Global Evaluation of Study Medication [Day 4 and Day 5]

  3. Time to first dose of rescue medication [Days 2 to 5]

  4. Percent of patients who took rescue medication on each study day [Days 2 to 5]

  5. Amount of rescue medication taken [Days 2 to 5]

  6. Time between doses of study medication [Days 2 to 5]

  7. Worst PI (derived from the mBPI-SF) [Days 2 to 5]

  8. Average PI (derived from the mBPI-SF) [Days 2 to 5]

  9. SPI 24 (categorical) [Day 4 and Day 5]

  10. Time-specific PI (categorical) [Days 2 to 5]

  11. SPI 24 (VAS) [Days 2 to 5]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Patients had required an elective, non-urgent laparoscopic cholecystectomy, as an outpatient procedure, with ASA Class I-III, with a Baseline Pain Intensity of moderate or severe on a categorical scale and ≥45 mm on a VAS (100 mm)

  • Patients were able to get their first dose of study medication within 8 hours after the end of surgery

Exclusion Criteria:

  • Patients could not undergo procedures expected to produce a greater degree of surgical trauma than the laparoscopic cholecystectomy alone, nor have acute pre-operative pain (other than biliary colic) nor chronic pain conditions, nor uncontrolled chronic conditions, nor cancer, nor a laboratory abnormality that the investigator considered to contraindicate study participation

  • Patient had any cognitive impairment that would, in the investigator's opinion, preclude study participation or compliance with protocol mandated procedures

  • Patient had a history of known alcohol, analgesic, or narcotic substance abuse within the one year prior to Screening

  • Patient had any laboratory abnormality at screening, that, in the opinion of the investigator, is not due to the condition requiring surgery and is not expected to resolve post-surgery, and would, therefore, contraindicate study participation

Contacts and Locations

Locations

Site City State Country Postal Code
1 Pfizer Investigational Site Birmingham Alabama United States 35213
2 Pfizer Investigational Site Daphne Alabama United States 36526
3 Pfizer Investigational Site Fairhope Alabama United States 36532
4 Pfizer Investigational Site Mobile Alabama United States 36617
5 Pfizer Investigational Site Mobile Alabama United States 36693
6 Pfizer Investigational Site Sheffield Alabama United States 35660
7 Pfizer Investigational Site Glendale Arizona United States 85306
8 Pfizer Investigational Site Glendale Arizona United States 85308
9 Pfizer Investigational Site Phoenix Arizona United States 85006
10 Pfizer Investigational Site Phoenix Arizona United States 85020
11 Pfizer Investigational Site Phoenix Arizona United States 85023
12 Pfizer Investigational Site Phoenix Arizona United States 85027
13 Pfizer Investigational Site Tucson Arizona United States 85710
14 Pfizer Investigational Site Tucson Arizona United States 85711
15 Pfizer Investigational Site Tucson Arizona United States 85712
16 Pfizer Investigational Site Anaheim California United States 92801
17 Pfizer Investigational Site Bakersfield California United States 93309
18 Pfizer Investigational Site Bakersfield California United States 93311
19 Pfizer Investigational Site Los Angeles California United States 90017
20 Pfizer Investigational Site Los Angeles California United States 90057
21 Pfizer Investigational Site Pasadena California United States 91109
22 Pfizer Investigational Site Sacramento California United States 95817
23 Pfizer Investigational Site San Jose California United States 95124
24 Pfizer Investigational Site Woodland California United States 95695
25 Pfizer Investigational Site Miami Florida United States 33136
26 Pfizer Investigational Site Miami Florida United States 33176
27 Pfizer Investigational Site Pensacola Florida United States 32504
28 Pfizer Investigational Site Blue Ridge Georgia United States 30513
29 Pfizer Investigational Site Marietta Georgia United States 30060
30 Pfizer Investigational Site Chicago Illinois United States 60611
31 Pfizer Investigational Site Maywood Illinois United States 60153
32 Pfizer Investigational Site Iowa City Iowa United States 52242
33 Pfizer Investigational Site Shreveport Louisiana United States 71105
34 Pfizer Investigational Site Baltimore Maryland United States 21229
35 Pfizer Investigational Site Germantown Maryland United States 20874
36 Pfizer Investigational Site Rockville Maryland United States 20850
37 Pfizer Investigational Site Silver Spring Maryland United States 20902
38 Pfizer Investigational Site Jackson Mississippi United States 39202
39 Pfizer Investigational Site Durham North Carolina United States 27710
40 Pfizer Investigational Site Winston-Salem North Carolina United States 27103-3315
41 Pfizer Investigational Site Winston-Salem North Carolina United States 27103
42 Pfizer Investigational Site Oklahoma City Oklahoma United States 73104
43 Pfizer Investigational Site Allentown Pennsylvania United States 18103
44 Pfizer Investigational Site Philadelphia Pennsylvania United States 19107-4998
45 Pfizer Investigational Site Pittsburgh Pennsylvania United States 15212
46 Pfizer Investigational Site Charleston South Carolina United States 29406
47 Pfizer Investigational Site Columbia South Carolina United States 29203
48 Pfizer Investigational Site Columbia South Carolina United States 29209
49 Pfizer Investigational Site Mt. Pleasant South Carolina United States 29464
50 Pfizer Investigational Site North Charleston South Carolina United States 29406
51 Pfizer Investigational Site Summerville South Carolina United States 29485
52 Pfizer Investigational Site Bristol Tennessee United States 37620
53 Pfizer Investigational Site Kingsport Tennessee United States 37660
54 Pfizer Investigational Site Houston Texas United States 77024
55 Pfizer Investigational Site Houston Texas United States 77055
56 Pfizer Investigational Site San Antonio Texas United States 78224
57 Pfizer Investigational Site Universal City Texas United States 78148
58 Pfizer Investigational Site Sandy Utah United States 84070
59 Pfizer Investigational Site Sandy Utah United States 84094
60 Pfizer Investigational Site West Jordan Utah United States 84088
61 Pfizer Investigational Site Norfolk Virginia United States 23517
62 Pfizer Investigational Site Suffolk Virginia United States 23434
63 Pfizer Investigational Site Renton Washington United States 98055
64 Pfizer Investigational Site Renton Washington United States 98058-5010
65 Pfizer Investigational Site Madison Wisconsin United States 53792

Sponsors and Collaborators

  • Pfizer

Investigators

  • Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00661635
Other Study ID Numbers:
  • VALA-0513-145
  • A3471085
First Posted:
Apr 18, 2008
Last Update Posted:
Apr 23, 2008
Last Verified:
Mar 1, 2008
Keywords provided by , ,
Laparoscopic Cholecystectomy Surgery, Acute Pain, Perioperative Pain
Additional relevant MeSH terms:
Valdecoxib

Study Results

No Results Posted as of Apr 23, 2008