A Study to Evaluate the Clinical Benefits of Tramadol/Acetaminophen (Ultracet) Versus Diclofenac in the Treatment of Pain in Patients With Ankylosing Spondylitis Receiving Stable Treatment of Disease Modifying Anti-Rheumatic Drugs (DMARDs) - Full Text View

Sponsor:	Johnson & Johnson Taiwan Ltd
Information provided by:	Johnson & Johnson Taiwan Ltd
ClinicalTrials.gov Identifier:	NCT00766402

Purpose

The purpose of the study is to investigate the clinical benefit of Tramadol/Acetaminophen (Ultracet) vs. NSAID (Diclofenac 50 mg) in the treatment of pain in patients with ankylosing spondylitis receiving stable treatment of disease modifying anti-rheumatic drugs (DMARDs).

Condition	Intervention	Phase
Ankylosing Spondylitis Pain	Drug: Tramadol /acetaminophen	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Study to Evaluate the Clinical Benefits of Tramadol/Acetaminophen (Ultracet) Versus Diclofenac in the Treatment of Pain in Patients With Ankylosing Spondylitis Receiving Stable Treatment of Disease Modifying Anti-Rheumatic Drugs (DMARDs)

Resource links provided by NLM:

Genetics Home Reference related topics: ankylosing spondylitis

MedlinePlus related topics: Ankylosing Spondylitis

Drug Information available for: Diclofenac sodium Diclofenac potassium Diclofenac Tramadol Acetaminophen CT 2584

U.S. FDA Resources

Further study details as provided by Johnson & Johnson Taiwan Ltd:

Primary Outcome Measures:

Compare the effectiveness of Ultracet and Diclofenac based on the mean change of VAS pain score at baseline, week 2, 4, and 8

Secondary Outcome Measures:

Compare the Bath AS Functional Index (BASFI) and Bath AS Disease Activity Index (BASDAI) and its independent components. Evaluate the quality of life by SF-36 and its components and Safety endpoint(s) at baseline, week 2, 4, and 8.

Estimated Enrollment:	80
Study Start Date:	September 2008
Study Completion Date:	February 2009

Detailed Description:

This study is a single center, open labeled, randomized, parallel group trial to compare the effectiveness (pain relief) and safety of tramadol 37.5 mg and acetaminophen 325 mg (Ultracet) with Diclofenac in patients with ankylosing spondylitis receiving stable treatment of disease modifying anti-rheumatic drugs (DMARDs). Patients who meet the entry criteria will be randomized to one of the two treatment groups (Ultracet and Diclofenac). One group will treated with Tramadol 37.5 mg/Acetaminophen 325 mg combination tablet and another group will treated with Diclofenac 50 mg tablet. Patients randomized into this study will be intructed take the one tablet Ultracet or Diclofenac 50 mg by mouth twice a day for 8 weeks. Evaluations will be performed as outlined: at screening, at baseline, and at weeks 2, 4, and 8. Non-steroidal anti-inflammatory drugs (NSAID) therapy with drugs such as ndomethacin or more recently COX-2 inhibitors, are used to control the inflammation and pain in patients with ankylosing spondylitis. However, long-term usage of NSAIDs, including COX-2 inhibitors, are known to have gastrointestinal and possible cardiovascular toxic effects, which could restrict their use. Tramadol is a centrally acting analgesic compound. Acetaminophen is another centrally acting analgesic. The primary endpoint is to compare the mean change from baseline in VAS pain score between the two treatment groups (Ultracet vs Diclofenac). Other endpoints include (1) to compare the Bath AS Functional Index (BASFI) and its independent components, (2) to compare the Bath AS Disease Activity Index (BASDAI) and its independent components, and (3) to evaluate the quality of life by SF-36 and its components. The safety of Ultracet and Diclofenac in this patient population by analyzing safety data in terms of adverse events and laboratory values.

Experimental Group will treated with Ultracet (Tramadol 37.5 mg/Acetaminophen 325 mg combination tablet). Control Group will treated with Diclofenac 50 mg tablet. Patients randomized into this study will be intructed take the one tablet Ultracet or Diclofenac 50 mg twice a day for 8 weeks.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Diagnosis of AS, as defined by Modified New York Criteria for Ankylosing Spondylitis
Low-back pain of at least 3 months duration improved by exercise and not relieved by rest
Limitation of lumbar spine in sagittal and frontal planes
Chest expansion decreased relative to normal values for age and sex
Bilateral sacroiliitis, grade 2-4 or Unilateral sacroiliitis, grade 3-4 (Stoke)
Patients are suffering from pain, with VAS pain score >=40 mm
Patients Between 18 and 70 years of age
Patients 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 <=1.2 mg/dl
Aspartate aminotransferase (AST [SGOT]) and alanine aminotransferase (ALT [SGPT]) <= 3 times the laboratory's upper limit of normal
ESR (Erythrocyte Sedimentation Rate) <= 28mm/hour and CRP (C- Reactive Protein) <=0.8mg/L
Willingness and capability to give written informed consent, written consent for data protection, willingness to participate, and to comply with the study

Exclusion Criteria:

Had an inadequate response to Tramadol HCl therapy, or have discontinued Tramadol HCl therapy due to adverse events
Have taken tramodal 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 (e.g. heart failure class III/IV NYHA, cardiac infarct within last 6 month), nervous system, pulmonary, renal, hepatic, endocrine or gastrointestinal disorders
Patients with a history of a severe psychological illness or condition such as to interfere with the patient's ability to understand the requirements of the study
Other major medical situations not suitable for the study judged by investigator's evaluation
Women with pregnancy or breast-feeding
Hepatitis B or C

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00766402

Sponsors and Collaborators

Johnson & Johnson Taiwan Ltd

Investigators

Study Director:

Johnson & Johnson Taiwan, Ltd. Clinical Trial

Johnson & Johnson Taiwan Ltd

More Information

No publications provided

Study ID Numbers:	CR015322
Study First Received:	October 3, 2008
Last Updated:	April 30, 2009
ClinicalTrials.gov Identifier:	NCT00766402 History of Changes
Health Authority:	Taiwan: Department of Health

Keywords provided by Johnson & Johnson Taiwan Ltd:

Ultracet
tramadol/acetaminophen
Ankylosing spondylitis
Pain

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Infection
Bone Diseases
Musculoskeletal Diseases
Sensory System Agents
Arthritis
Therapeutic Uses
Spondylitis, Ankylosing
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Spondylarthritis
Analgesics, Opioid
Acetaminophen

Spondylitis
Ankylosis
Spondylarthropathies
Spinal Diseases
Tramadol
Joint Diseases
Cyclooxygenase Inhibitors
Central Nervous System Depressants
Diclofenac
Narcotics
Enzyme Inhibitors
Pharmacologic Actions
Bone Diseases, Infectious
Analgesics, Non-Narcotic
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010