Safety and Efficacy of Celecoxib Versus Diclofenac in the Treatment of Ankylosing Spondylitis

Sponsor

Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT00648141

Collaborator

(none)

458

Enrollment

Locations

Arms

Duration (Months)

9.7

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To compare the safety and efficacy of once-daily and twice-daily celecoxib versus diclofenac for the treatment of ankylosing spondylitis

Condition or Disease	Intervention/Treatment	Phase
Spondylitis, Ankylosing	Drug: Celecoxib Drug: Celecoxib Drug: Diclofenac	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

458 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

A 12-Week Symptomatic Effect Evaluation to Compare Celecoxib 200 mg QD, Celecoxib 200 mg BID and Diclofenac 75 mg SR BID in Patients With Ankylosing Spondylitis

Study Start Date :

Jan 1, 2003

Actual Study Completion Date :

Jan 1, 2005

Arms and Interventions

Arm	Intervention/Treatment
Experimental: A	Drug: Celecoxib 200 mg oral capsule once daily for 12 weeks
Experimental: B	Drug: Celecoxib 200 mg oral capsule twice daily for 12 weeks
Active Comparator: C	Drug: Diclofenac 75 mg oral capsule twice daily for 12 weeks

Arm

Intervention/Treatment

Experimental: A

Drug: Celecoxib

200 mg oral capsule once daily for 12 weeks

Experimental: B

Drug: Celecoxib

200 mg oral capsule twice daily for 12 weeks

Active Comparator: C

Drug: Diclofenac

75 mg oral capsule twice daily for 12 weeks

Outcome Measures

Primary Outcome Measures

Change from baseline in global pain intensity as assessed by visual analog scale (VAS) [Week 12]
Responder rates, defined as 50% improvement in VAS from baseline [Week 12]

Secondary Outcome Measures

Patient's and physician's global assessment of disease activity [Weeks 1, 2, 6, and 12]
Spinal pain [Weeks 1, 2, 6, and 12]
Short Form-12 [Weeks 1, 2, 6, and 12]
Adverse events [Week 12]
Physical evaluation [Week 12]
Laboratory tests [Week 12]
Nocturnal pain [Weeks 1, 2, 6, and 12]
Composite Bath Ankylosing Spondylitis Disease Activity Index [Weeks 1, 2, 6, and 12]
Bath Ankylosing Spondylitis Metrology Index [Weeks 1, 2, 6, and 12]
Change from baseline in C-reactive protein measurement [Week 12]
Responder rates, defined as 50% improvement in VAS from baseline [Weeks 1, 2, and 6]
Mobility parameters [Weeks 1, 2, 6, and 12]
Change from baseline in Assessments in Ankylosing Spondylitis 20 score [Weeks 1, 2, 6, and 12]
Change from baseline in global pain intensity [Weeks 1, 2, and 6]
Bath Ankylosing Spondylitis Functional Index [Weeks 1, 2, 6, and 12]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Diagnosis of ankylosing spondylitis defined according to modified New York criteria, and with axial involvement
Requiring daily treatment with nonsteroidal anti-inflammatory drugs during the previous 30 days

Exclusion Criteria:

Patients with inflammatory enterophathy, and with extra-articular manifestations
Patients with known vertebral compression
Received corticosteroids 6 weeks prior to the baseline visit; patients on stable dose of prednisolone equivalents ≤ 10 mg/ day for at least 14 days before randomization were permitted

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Pfizer Investigational Site	Aachen	Germany	52064
2	Pfizer Investigational Site	Bad Aibling	Germany	83043
3	Pfizer Investigational Site	Bad Iburg	Germany	49186
4	Pfizer Investigational Site	Bad Muender	Germany	31848
5	Pfizer Investigational Site	Berlin	Germany	10559
6	Pfizer Investigational Site	Berlin	Germany	10777
7	Pfizer Investigational Site	Berlin	Germany	12200
8	Pfizer Investigational Site	Berlin	Germany	12247
9	Pfizer Investigational Site	Berlin	Germany	13125
10	Pfizer Investigational Site	Berlin	Germany	14059
11	Pfizer Investigational Site	Berlin	Germany	D-10098
12	Pfizer Investigational Site	Bonn	Germany	53179
13	Pfizer Investigational Site	Celle / OT Klein Hehlen	Germany	29223
14	Pfizer Investigational Site	Chemnitz	Germany	09130
15	Pfizer Investigational Site	Darmstadt	Germany	64295
16	Pfizer Investigational Site	Dresden	Germany
17	Pfizer Investigational Site	Duesseldorf	Germany	40211
18	Pfizer Investigational Site	Elmshorn	Germany	25335
19	Pfizer Investigational Site	Erlangen	Germany	91056
20	Pfizer Investigational Site	Halle	Germany	06128
21	Pfizer Investigational Site	Hannover	Germany	30161
22	Pfizer Investigational Site	Heidelberg	Germany	69120
23	Pfizer Investigational Site	Hildesheim	Germany	31134
24	Pfizer Investigational Site	Hofheim	Germany	65719
25	Pfizer Investigational Site	Hoyerswerda	Germany	02977
26	Pfizer Investigational Site	Koeln	Germany	51107
27	Pfizer Investigational Site	Leipzig	Germany	04107
28	Pfizer Investigational Site	Leverkusen	Germany	51373
29	Pfizer Investigational Site	Magdeburg	Germany	39104
30	Pfizer Investigational Site	Mannheim	Germany	68165
31	Pfizer Investigational Site	Muenchen	Germany	80336
32	Pfizer Investigational Site	Neubrandenburg	Germany	17033
33	Pfizer Investigational Site	Oldenburg	Germany	26121
34	Pfizer Investigational Site	Osnabrueck	Germany	49074
35	Pfizer Investigational Site	Pirna	Germany	01796
36	Pfizer Investigational Site	Ratingen	Germany	D40882
37	Pfizer Investigational Site	Regensburg	Germany
38	Pfizer Investigational Site	Remscheid	Germany	42897
39	Pfizer Investigational Site	Rheine	Germany	48431
40	Pfizer Investigational Site	Rostock	Germany	18059
41	Pfizer Investigational Site	Saarbruecken	Germany	66111
42	Pfizer Investigational Site	Seesen	Germany	38723
43	Pfizer Investigational Site	Surwold	Germany	26903
44	Pfizer Investigational Site	Tuebingen	Germany	72076
45	Pfizer Investigational Site	Villingen-Schwenningen	Germany	78054
46	Pfizer Investigational Site	Weener	Germany	26826
47	Pfizer Investigational Site	Winsen/Luhe	Germany	21423