Randomized, Double Blind, Multicenter Study of the Safety and Efficacy of Valdecoxib 40 mg Once Daily Compared With Diclofenac 75 mg Twice Daily in Acute Low Back Pain

Sponsor

Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT00649610

Collaborator

(none)

340

Enrollment

Locations

Arms

5.9

Duration (Months)

11.7

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The pain relief, safety, and tolerability of valdecoxib 40 mg once daily compared with diclofenac 75 mg twice daily for acute low back pain was studied. The effect of valdecoxib on the patient's level of disability and quality of life was also studied.

Condition or Disease	Intervention/Treatment	Phase
Low Back Pain	Drug: valdecoxib Drug: diclofenac	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

340 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Randomized, Double Blind, Multicenter Study of the Safety and Efficacy of Valdecoxib 40 mg Once Daily vs. Diclofenac 75 mg Twice Daily in Subjects With Acute Low Back Pain

Study Start Date :

Nov 1, 2002

Actual Study Completion Date :

May 1, 2003

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Arm 1	Drug: valdecoxib valdecoxib 40 mg QD for 7 days with a second dose of 40 mg the first day
Active Comparator: Arm 2	Drug: diclofenac diclofenac 75 mg twice daily (BID) for 7 days

Arm

Intervention/Treatment

Active Comparator: Arm 1

Drug: valdecoxib

valdecoxib 40 mg QD for 7 days with a second dose of 40 mg the first day

Active Comparator: Arm 2

Drug: diclofenac

diclofenac 75 mg twice daily (BID) for 7 days

Outcome Measures

Primary Outcome Measures

Subject-rated VAS Pain Intensity (0 - 100 mm), which was evaluated using the change from baseline [Day 3]

Secondary Outcome Measures

Patient global evaluation [Day 3 and Day 7]
Subject's functional capacity as measured by the Oswestry Low Back Pain and Disability Questionnaire [Day 7]
Subject's quality of life as measured by the Acute short form (SF)-36 (8 domains) [Day 7]
Pain Relief [Day 3 and Day 7]
Composite Upper Gastrointestinal (UGI) Tolerability was calcluated. A subject had a UGI event if the subject reported at least 1 of the following: moderate or severe nausea, or moderate or severe abdominal pain, or moderate or severe dyspepsia [Day 7]
VAS Pain Intensity (0-100 mm) [Day 7]
Categorical Pain Intensity [Day 3 and Day 7]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Acute low back pain, defined as either class 1a or class 2a according to the Quebec Task Force Classification and categorized as moderate-severe in the Pain Intensity Categorical Scale and Visual analogue score (VAS) greater or equal to 50 mm
Acute low back pain was to have started at least 72 hours prior to inclusion in the trial and more than 6 weeks after the last episode of acute low back pain
History of at least 1 reported episode of acute low back pain in the last 5 years

Exclusion Criteria:

History of inflammatory arthritis, chronic pain, metastasis, Paget's disease, or other diseases known to cause pain
Moderate to severe scoliosis
Back pain due to major trauma or visceral disorder
Unwilling to refrain from commencing concomitant physiotherapy
Active or suspected esophageal, gastric pyloric channel, or duodenal ulceration or bleeding within 30 days prior to the first dose of study medication
Any known laboratory abnormality, which in the opinion of the investigator, would contraindicate study participation
Subject was pregnant or lactating woman , or was a woman of childbearing potential not using an acceptable method of contraception

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Bs. As.		Argentina
2	Pfizer Investigational Site	Buenos Aires		Argentina	C1221ACI
3	Pfizer Investigational Site	Goiania	Goias	Brazil	74085-450
4	Pfizer Investigational Site	Curitiba	Parana	Brazil	80430-210
5	Pfizer Investigational Site	Curitiba	PR	Brazil
6	Pfizer Investigational Site	Petropolis	Rio de Janeiro	Brazil	25620-040
7	Pfizer Investigational Site	Sao Paulo	SP	Brazil	04023-900
8	Pfizer Investigational Site	Sao Paulo	SP	Brazil	04029-000
9	Pfizer Investigational Site	Sao Paulo	SP	Brazil	05403-012
10	Pfizer Investigational Site	Sao Paulo		Brazil	05001-000
11	Pfizer Investigational Site	Santiago		Chile
12	Pfizer Investigational Site	Bogota	D.c.	Colombia
13	Pfizer Investigational Site	Bogota D.c		Colombia
14	Pfizer Investigational Site	Cali-valle		Colombia
15	Pfizer Investigational Site	Cartago City	Cartago	Costa Rica	7051
16	Pfizer Investigational Site	Hatillo	San Jose	Costa Rica	476-1002
17	Pfizer Investigational Site	Quito	Pichincha	Ecuador
18	Pfizer Investigational Site	Toluca	Edo. de Mexico	Mexico	50080
19	Pfizer Investigational Site	Zapopan	Jalisco	Mexico	45040
20	Pfizer Investigational Site	Zapopan	Jalisco	Mexico	45200
21	Pfizer Investigational Site	Puebla		Mexico	72000
22	Pfizer Investigational Site	Puebla		Mexico	72070
23	Pfizer Investigational Site	Puebla		Mexico	72410
24	Pfizer Investigational Site	Lima		Peru	LIMA 11
25	Pfizer Investigational Site	Lima		Peru	LIMA 27
26	Pfizer Investigational Site	Caracas	DF	Venezuela	1020
27	Pfizer Investigational Site	Caracas	DF	Venezuela	1051
28	Pfizer Investigational Site	Caracas	DF	Venezuela	1070
29	Pfizer Investigational Site	Caracas		Venezuela