Study Of Celecoxib Or Diclofenac For Efficacy and Safety In Chinese Patients With Ankylosing Spondylitis

NCT00762463 | Completed Phase 3 Results

• 1 other identifier: A3191348
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 5

Brief Summary

This is a local, multicenter, randomized, active comparator, double-blind, parallel group study with extension will be conducted to evaluate the efficacy and safety of celecoxib versus diclofenac SR in the treatment of Chinese patients with Ankylosing Spondylitis (AS).

Conditions

Ankylosing Spondylitis

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in Participant's Assessment of Global Pain Intensity at Week 6

  100-millimeter (mm) Visual Analog Scale (VAS) score specified participant's assessment of overall pain intensity in the previous 48 hours, in response to the following question "What has been your global pain intensity in the last 48 hours?" 0=no pain to 100=worst pain. Change from baseline of less than (\<) 0 indicated improvement.

  Baseline, Week 6

• Participant's Assessment of Global Pain Intensity at Baseline

  100-mm VAS scores specified participant's assessment of global pain intensity in the previous 48 hours, in response to the following question "What has been your global pain intensity in the last 48 hours?" 0=no pain to 100=worst pain. Lower scores indicated less pain.

  Baseline

Secondary Outcomes (24)

• Change From Baseline in Participant's Assessment of Global Pain Intensity at Weeks 2 and 4

  Baseline, Weeks 2, 4

• Change From Baseline in Participant's Assessment of Global Pain Intensity at Week 12

  Baseline, Week 12

• Change From Baseline in Participant's Global Assessment of Disease Activity at Weeks 2, 4, and 6

  Baseline, Weeks 2, 4, 6

• Change From Baseline in Participant's Global Assessment of Disease Activity at Week 12

  Baseline, Week 12

• Change From Baseline in Physician's Global Assessment of Disease Activity at Weeks 2, 4, and 6

  Baseline, Weeks 2, 4, 6

Study Arms (2)

Celecoxib 200 mg QD

EXPERIMENTAL

Drug: Celecoxib

Diclofenac SR 75 mg QD

ACTIVE COMPARATOR

Drug: Diclofenac SR

Interventions

Celecoxib DRUG

capsule, 200 mg QD, 6-12 weeks

Celecoxib 200 mg QD

Diclofenac SR DRUG

tablet, 75 mg QD,6-12 weeks

Diclofenac SR 75 mg QD

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Meet the 1984 Modified New York Criteria for Classification of Ankylosing Spondylitis
• With axial involvement
• Without peripheral joint involvement (synovitis) at the time of study entry, (excluding involvement of the hips, knees and shoulders)
• Need for daily treatment with NSAIDs during the previous 30 days before study entry

You may not qualify if:

• Known inflammatory enteropathy (eg, ulcerative colitis, Crohn's disease, etc)
• Presence of extra-articular manifestations (eg, uveitis, endocarditis, etc.)
• Known vertebral compression
• Need for a corset during the study

Sponsors & Collaborators

• Pfizer's Upjohn has merged with Mylan to form Viatris Inc.: lead

Study Sites (5)

Pfizer Investigational Site

Guangzhou, Guangdong, 510630, China

Location

Pfizer Investigational Site

Xi’an, Shanxi, 710032, China

Location

Pfizer Investigational Site

Chengdu, Sichuan, 610041, China

Location

Pfizer Investigational Site

Beijing, 100020, China

Location

Pfizer Investigational Site

Beijing, 100853, China

Location

Related Publications (1)

• Huang F, Gu J, Liu Y, Zhu P, Zheng Y, Fu J, Pan S, Le S. Efficacy and safety of celecoxib in chinese patients with ankylosing spondylitis: a 6-week randomized, double-blinded study with 6-week open-label extension treatment. Curr Ther Res Clin Exp. 2014 Dec 5;76:126-33. doi: 10.1016/j.curtheres.2014.08.002. eCollection 2014 Dec.

  PMID: 25516774 DERIVED

Related Links

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

MeSH Terms

Conditions

Spondylitis, Ankylosing

Interventions

Celecoxib

Condition Hierarchy (Ancestors)

Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

The protocol does not specify time points for secondary endpoints; these are described in the statistical analysis plan.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2008
• First Posted: September 30, 2008
• Study Start: July 1, 2009
• Primary Completion: June 1, 2010
• Study Completion: August 1, 2010
• Last Updated: February 2, 2021
• Results First Posted: August 23, 2011

Record last verified: 2021-01

Locations

CN (5)