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)
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ClinicalTrials.gov Identifier: NCT00766402 |
Recruitment Status :
Terminated
First Posted : October 6, 2008
Last Update Posted : October 15, 2014
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Condition or disease | Intervention/treatment | Phase |
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Spondylitis, Ankylosing Pain | Drug: Tramadol /acetaminophen Drug: Diclofenac | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 8 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Study to Evaluate the Clinical Benefits of Tramadol/Acetaminophen (Ultracet®) vs. Diclofenac (Voltaren®) in the Treatment of Pain in Patients With Ankylosing Spondylitis Receiving Stable Treatment of Disease Modifying Anti-rheumatic Drugs (DMARDs) |
Study Start Date : | October 2008 |
Actual Primary Completion Date : | February 2009 |
Actual Study Completion Date : | March 2009 |

Arm | Intervention/treatment |
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Experimental: Tramadol/Acetaminophen
Participants will receive a combination tablet of 37.5 milligram (mg) tramadol and 325 mg acetaminophen, orally twice daily up to 8 weeks.
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Drug: Tramadol /acetaminophen
Participants will receive a combination tablet of 37.5 milligram (mg) tramadol and 325 mg acetaminophen, orally twice daily up to 8 weeks.
Other Name: Ultracet® |
Active Comparator: Diclofenac
Participants will receive 50 mg diclofenac tablet, orally twice daily up to 8 weeks.
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Drug: Diclofenac
Participants will receive 50 mg diclofenac tablet, orally twice daily up to 8 weeks.
Other Name: Voltaren® |
- Change From Baseline in Visual Analogue Scale (VAS) Score at Week 2 [ Time Frame: Baseline and 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.
- Change From Baseline in Visual Analogue Scale (VAS) Score at Week 4 [ Time Frame: Baseline and 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.
- Change From Baseline in Visual Analogue Scale (VAS) Score at Week 8 [ Time Frame: Baseline and 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.
- Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Total and Sub-scale Scores at Week 2, 4, 8 [ Time Frame: Baseline and Week 2, 4 and 8 ]The BASFI is a self-assessment instrument used to assess function. It comprises of 8 specific questions regarding function in ankylosing spondylitis and 2 questions to identify participant's ability to cope up with everyday life. Each question is answered on a 100 millimeter (mm) horizontal VAS. The mean of VAS score gives BASFI score between 0 to 100 where 0=easy to 100=impossible.
- Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total and Sub-scale Scores at Week 2, 4, 8 [ Time Frame: Baseline, Week 2, 4 and 8 ]The BASDAI comprises of 6 questions pertaining to 5 major symptoms of ankylosing spondylitis: a) fatigue; b) spinal pain; c) peripheral arthritis; d) enthesopathy; and e) morning stiffness. It is used to measure disease activity. It consists of VAS ranging from 0 to 100 where 0 = no problem and 100 = worst problem. To give each symptom equal weightage, the mean (average) of two scores relating to morning stiffness is taken. The resulting 0 to 500 is divided by 5 to get BASDAI score between 0 to 100 (0 = no problem and 100 = worst problem).
- Quality of Life Medical outcome Study Health Survey Short Form 36 (QoL-SF36) Total and Sub-scale Scores [ Time Frame: Baseline and Week 8 ]The QoL-SF36 is a general health questionnaire that comprises of physical function, social function, and the participants' perception of general health, well-being and satisfaction with the treatment .
- Number of Participants with Adverse Event (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Week 2 to 8 ]An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
- Exclusion Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00766402
Study Director: | Johnson & Johnson Taiwan, Ltd. Clinical Trial | Johnson & Johnson Taiwan Ltd |
Responsible Party: | Johnson & Johnson Taiwan Ltd |
ClinicalTrials.gov Identifier: | NCT00766402 |
Other Study ID Numbers: |
CR015322 TRAMAPPAI4034 ( Other Identifier: Johnson & Johnson Taiwan, Ltd. ) |
First Posted: | October 6, 2008 Key Record Dates |
Last Update Posted: | October 15, 2014 |
Last Verified: | October 2014 |
Spondylitis, ankylosing Pain Ultracet |
Diclofenac Voltaren Tramadol/acetaminophen |
Spondylitis Spondylarthritis Spondylitis, Ankylosing Bone Diseases, Infectious Infections Bone Diseases Musculoskeletal Diseases Spinal Diseases Arthritis Joint Diseases Spondylarthropathies Ankylosis Acetaminophen Diclofenac Tramadol |
Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Antipyretics Anti-Inflammatory Agents, Non-Steroidal Anti-Inflammatory Agents Antirheumatic Agents Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Analgesics, Opioid Narcotics Central Nervous System Depressants |