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)

October 14, 2014 updated by: Johnson & Johnson Taiwan Ltd

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)

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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

This is a single center, open labeled (all people know the identity of intervention), randomized (study drug assigned by chance), parallel group (a medical research study comparing the response in two or more groups of participants receiving different interventions (treatments) trial to compare the effectiveness (pain relief) and safety of tramadol 37.5 mg and acetaminophen 325 mg with diclofenac in participants with ankylosing spondylitis receiving stable treatment of disease modifying anti-rheumatic drugs (DMARDs). Participants who meet the eligibility criteria will be randomized to one of the two treatment groups (tramadol/acetaminophen and Diclofenac). One group will be treated with tramadol 37.5 mg/acetaminophen 325 mg combination tablet and another group will be treated with diclofenac 50 mg tablet. Participants randomized into this study will be instructed to take one tablet Ultracet or diclofenac 50 mg orally, twice a day for 8 weeks. Evaluations will be performed as outlined: at Screening, at Baseline, and at Weeks 2, 4, and 8. The primary efficacy parameter is to compare the mean change from Baseline in visual analogue scale (VAS) pain score between the two treatment groups (tramadol/acetaminophen versus diclofenac). Participants' safety will be monitored throughout the study.

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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 Names:
  • Ultracet®
Active Comparator: Diclofenac
Participants will receive 50 mg diclofenac tablet, orally twice daily up to 8 weeks.
Drug: Diclofenac
Participants will receive 50 mg diclofenac tablet, orally twice daily up to 8 weeks.
Other Names:
  • Voltaren®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and Week 2
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.
Baseline and Week 4
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.
Baseline and Week 8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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).
Baseline, Week 2, 4 and 8
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 .
Baseline and Week 8
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.
Week 2 to 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johnson & Johnson Taiwan Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Actual)

February 1, 2009

Study Completion (Actual)

March 1, 2009

Study Registration Dates

First Submitted

October 3, 2008

First Submitted That Met QC Criteria

October 3, 2008

First Posted (Estimate)

October 6, 2008

Study Record Updates

Last Update Posted (Estimate)

October 15, 2014

Last Update Submitted That Met QC Criteria

October 14, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR015322
  • TRAMAPPAI4034 (Other Identifier: Johnson & Johnson Taiwan, Ltd.)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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