An Efficacy and Safety Study of Tramadol/Acetaminophen Versus Diclofenac in the Treatment of Pain in Participants With Ankylosing Spondylitis Receiving Stable Treatment of Disease Modifying Anti-rheumatic Drugs (DMARDs)

NCT00766402 | Terminated Phase 4

• 2 other identifiers: CR015322TRAMAPPAI4034
• Study Type: interventional
• Target: 8
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of the study is to investigate the clinical benefit of tramadol/acetaminophen versus non-steroidal anti-inflammatory drugs (NSAID) (diclofenac 50 milligram \[mg\]) in the treatment of pain in participants with ankylosing spondylitis (inflammation of the spine causing pain and stiffness) receiving stable treatment of disease modifying anti-rheumatic drugs (DMARDs).

Conditions

Spondylitis, Ankylosing; Pain

Keywords

Spondylitis, ankylosing; Pain; Ultracet; Diclofenac; Voltaren; Tramadol/acetaminophen

Outcome Measures

Primary Outcomes (3)

• Change From Baseline in Visual Analogue Scale (VAS) Score at Week 2

  Visual Analogue Scale (VAS) is a pain rating scale. The range of VAS score is from 0 to 10 where 0 = no pain and 10 = unbearable pain.

  Baseline and Week 2

• Change From Baseline in Visual Analogue Scale (VAS) Score at Week 4

  Visual Analogue Scale (VAS) is a pain rating scale. The range of VAS score is from 0 to 10 where 0 = no pain and 10 = unbearable pain.

  Baseline and Week 4

• Change From Baseline in Visual Analogue Scale (VAS) Score at Week 8

  Visual Analogue Scale (VAS) is a pain rating scale. The range of VAS score is from 0 to 10 where 0 = no pain and 10 = unbearable pain.

  Baseline and Week 8

Secondary Outcomes (4)

• Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Total and Sub-scale Scores at Week 2, 4, 8

  Baseline and Week 2, 4 and 8

• Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total and Sub-scale Scores at Week 2, 4, 8

  Baseline, Week 2, 4 and 8

• Quality of Life Medical outcome Study Health Survey Short Form 36 (QoL-SF36) Total and Sub-scale Scores

  Baseline and Week 8

• Number of Participants with Adverse Event (AEs) and Serious Adverse Events (SAEs)

  Week 2 to 8

Study Arms (2)

Tramadol/Acetaminophen

EXPERIMENTAL

Participants will receive a combination tablet of 37.5 milligram (mg) tramadol and 325 mg acetaminophen, orally twice daily up to 8 weeks.

Drug: Tramadol /acetaminophen

Diclofenac

ACTIVE COMPARATOR

Participants will receive 50 mg diclofenac tablet, orally twice daily up to 8 weeks.

Drug: Diclofenac

Interventions

Tramadol /acetaminophen DRUG

Participants will receive a combination tablet of 37.5 milligram (mg) tramadol and 325 mg acetaminophen, orally twice daily up to 8 weeks.

Also known as: Ultracet®

Tramadol/Acetaminophen

Diclofenac DRUG

Participants will receive 50 mg diclofenac tablet, orally twice daily up to 8 weeks.

Also known as: Voltaren®

Diclofenac

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of ankylosing spondylitis (AS), as defined by Modified New York Criteria for ankylosing spondylitis: a) Low-back pain of at least 3 months duration improved by exercise and not relieved by rest b) Limitation of lumbar spine in sagittal and frontal planes c) Chest expansion decreased relative to normal values for age and sex d) Bilateral sacroiliitis, grade 2-4 or Unilateral sacroiliitis, grade 3-4 (Stoke)
• Participants are suffering from pain, with visual analogue scale (VAS) pain score greater than or equal to (\>=) 40 millimeter (mm)
• Participants are receiving disease modifying anti-rheumatic drugs (DMARDs), which have reached to the stable dosage within 4 weeks prior to the randomization visit - Serum creatinine less than or equal to (\<=) 1.2 milligram per deciliter (mg/dL)
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \<= 3 times the laboratory's upper limit of normal

You may not qualify if:

• Had an inadequate response to tramadol hydrochloride (HCl) therapy, or have discontinued tramadol HCl therapy due to adverse events
• Have taken tramadol HCl within 4 weeks prior to the entry of the study
• Have taken other medications for pain relief within 4 weeks prior to the entry of the study, except rescue medications
• Evidence of significant uncontrolled concomitant diseases such as cardiovascular disease, nervous system, pulmonary, renal, hepatic, endocrine or gastrointestinal disorders
• Women with pregnancy or breast-feeding

Sponsors & Collaborators

• Johnson & Johnson Taiwan Ltd: lead

MeSH Terms

Conditions

Spondylitis, Ankylosing; Pain

Interventions

Ultracet; Diclofenac

Condition Hierarchy (Ancestors)

Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Johnson & Johnson Taiwan, Ltd. Clinical Trial

  Johnson & Johnson Taiwan Ltd

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2008
• First Posted: October 6, 2008
• Study Start: October 1, 2008
• Primary Completion: February 1, 2009
• Study Completion: March 1, 2009
• Last Updated: October 15, 2014

Record last verified: 2014-10