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An Efficacy, Safety and Effects on Quality of Life of Tramadol/Paracetamol as Add-on Therapy in Chronic Osteoarthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01728246
Recruitment Status : Completed
First Posted : November 19, 2012
Results First Posted : January 14, 2013
Last Update Posted : February 12, 2013
Sponsor:
Information provided by (Responsible Party):
Janssen Pharmaceutica

Tracking Information
First Submitted Date  ICMJE November 13, 2012
First Posted Date  ICMJE November 19, 2012
Results First Submitted Date  ICMJE December 7, 2012
Results First Posted Date  ICMJE January 14, 2013
Last Update Posted Date February 12, 2013
Study Start Date  ICMJE October 2007
Actual Primary Completion Date May 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 7, 2012)
  • Change From Baseline in Visual Analogue Scale for Pain (VAS-pain) Score at Week 2 [ Time Frame: Baseline and Week 2 ]
    VAS is a 100 millimeter (mm) scale. Intensity of pain range: 0 mm=no pain to 100 mm=worst possible pain. Change=scores at observation minus score at baseline. An increase in score from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.
  • Change From Baseline in VAS-pain Score at Week 4 [ Time Frame: Baseline and Week 4 Last Observation Carried Forward (LOCF) ]
    VAS is a 100 mm scale. Intensity of pain range: 0 mm=no pain to 100 mm=worst possible pain. Change=scores at observation minus score at Baseline. An increase in score from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.
  • Change From Baseline in Oswestry Disability Index (ODI) Score at Week 2 [ Time Frame: Baseline and Week 2 ]
    The ODI is a low back pain-specific, validated instrument that consists of questions related to limitations in performing specific activities of daily living and 1 question related to pain intensity. The ODI is a self-administered questionnaire that is usually completed in less than 5 minutes. The ODI consists of 10 sections. Each section consists of 6 statements ranked from 0 to 5 (0=good to 5=worse). A higher score represents greater disability.
  • Change From Baseline in ODI Score at Week 4 [ Time Frame: Baseline and Week 4 (LOCF) ]
    The ODI is a low back pain-specific, validated instrument that consists of questions related to limitations in performing specific activities of daily living and 1 question related to pain intensity. The ODI is a self-administered questionnaire that is usually completed in less than 5 minutes. The ODI consists of 10 sections. Each section consists of 6 statements ranked from 0 to 5 (0=good to 5=worse). A higher score represents greater disability.
  • Percentage of Participants Who Discontinued Because of Rescue Medication [ Time Frame: Baseline up to Week 4 ]
    Rescue medications are medicines that may be administered to the participants when the efficacy of the study drug is not satisfactory, or the effect of the study drug is too great and is likely to cause a hazard to the participant, or to manage an emergency situation.
  • Time to Discontinuation Because of Rescue Medication [ Time Frame: Baseline up to Week 4 ]
    Rescue medications are medicines that may be administered to the participants when the efficacy of the study drug is not satisfactory, or the effect of the study drug is too great and is likely to cause a hazard to the participant, or to manage an emergency situation.
Original Primary Outcome Measures  ICMJE
 (submitted: November 13, 2012)
  • Change From Baseline in Visual Analogue Scale for Pain (VAS-pain) Score at Week 2 [ Time Frame: Baseline and Week 2 ]
    VAS is a 100 millimeter (mm) scale. Intensity of pain range: 0 mm=no pain to 100 mm=worst possible pain. Change=scores at observation minus score at baseline. An increase in score from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.
  • Change From Baseline in VAS-pain Score at Week 4 [ Time Frame: Baseline and Week 4 ]
    VAS is a 100 mm scale. Intensity of pain range: 0 mm=no pain to 100 mm=worst possible pain. Change=scores at observation minus score at Baseline. An increase in score from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.
  • Change From Baseline in Oswestry Disability Index (ODI) Score at Week 2 [ Time Frame: Baseline and Week 2 ]
    The ODI is a low back pain-specific, validated instrument that consists of questions related to limitations in performing specific activities of daily living and 1 question related to pain intensity. The ODI is a self-administered questionnaire that is usually completed in less than 5 minutes. The ODI consists of 10 sections. Each section consists of 6 statements ranked from 0 to 5 (0=good to 5=worse). A higher score represents greater disability.
  • Change From Baseline in ODI Score at Week 4 [ Time Frame: Baseline and Week 4 ]
    The ODI is a low back pain-specific, validated instrument that consists of questions related to limitations in performing specific activities of daily living and 1 question related to pain intensity. The ODI is a self-administered questionnaire that is usually completed in less than 5 minutes. The ODI consists of 10 sections. Each section consists of 6 statements ranked from 0 to 5 (0=good to 5=worse). A higher score represents greater disability.
  • Percentage of Participants Who Discontinued Because of Rescue Medication [ Time Frame: Baseline up to Week 4 ]
    Rescue medications are medicines identified in the protocol as those that may be administered to the participants when the efficacy of the study drug is not satisfactory, or the effect of the study drug is too great and is likely to cause a hazard to the participant, or to manage an emergency situation.
  • Time to Discontinuation Because of Rescue Medication [ Time Frame: Baseline up to Week 4 ]
    Rescue medications are medicines identified in the protocol as those that may be administered to the participants when the efficacy of the study drug is not satisfactory, or the effect of the study drug is too great and is likely to cause a hazard to the participant, or to manage an emergency situation.
Change History Complete list of historical versions of study NCT01728246 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Efficacy, Safety and Effects on Quality of Life of Tramadol/Paracetamol as Add-on Therapy in Chronic Osteoarthritis
Official Title  ICMJE A Randomized Controlled Trial on the Efficacy, Safety and Quality of Life Effects of Add-on Tramadol/Paracetamol Combination in Chronic Osteoarthritis
Brief Summary The purpose of this study is to evaluate the efficacy, safety and effects on Quality of Life (QOL) of tramadol/paracetamol (APAP) as an add-on therapy (medication taken in addition to another medication) in Filipino participants with chronic (lasting a long time) osteoarthritis (disorder, which is seen mostly in older persons, in which the joints become painful and stiff).
Detailed Description This is an open-label (all people know the identity of the intervention), randomized (study drug assigned by chance), controlled study to evaluate the efficacy, safety and effects on QOL of tramadol/APAP as an add-on therapy in Filipino participants suffering from chronic pain because of chronic osteoarthritis. Participants will be randomly assigned to 2 groups: tramadol/APAP group and non tramadol/APAP group. Participants in tramadol/APAP group will receive celecoxib 200 milligram (mg) and fixed dose combination of tramadol (37.5 mg)/APAP (325 mg) as add on therapy, while the participants in non-tramadol/APAP group will receive celecoxib 200 mg only. The total duration of the study will be 4 weeks. The participants in both the groups will be given celecoxib 200 mg once daily for 4 weeks. In addition, the participants in the tramadol/APAP group will be given add-on tramadol/APAP doses 3 times a day for 4 weeks. Participants will be asked to return for follow-up at Weeks 2 and 4. Efficacy will be assessed using 100 millimeter (mm) Visual Analog Scale (VAS) while QOL will be assessed using the Oswestry Disability Index (ODI). Participant safety will be monitored throughout the study.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Osteoarthritis
Intervention  ICMJE
  • Drug: Tramadol/Paracetamol (APAP)
    Celecoxib 200 milligram (mg) once daily for 4 weeks and fixed dose combination of Tramadol 37.5 mg/Paracetamol 325 mg thrice daily for 4 weeks as add-on therapy.
  • Drug: Non-Tramadol/APAP
    Celecoxib 200 mg alone once daily for 4 weeks.
Study Arms  ICMJE
  • Experimental: Tramadol/Paracetamol (APAP)
    Intervention: Drug: Tramadol/Paracetamol (APAP)
  • Active Comparator: Non-Tramadol/APAP
    Intervention: Drug: Non-Tramadol/APAP
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 13, 2012)
473
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2008
Actual Primary Completion Date May 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosed with chronic osteoarthritis of knee or hip for greater than (>) or equal to (=) 1 year (based on the American College of Rheumatology (ACR) diagnostic criteria for osteoarthritis), who are experiencing at least moderate osteoarthritis pain (>=50 millimeter [mm] in 100 mm Visual Analog Scale [VAS])
  • On any Cyclooxygenase - 2 (COX-2) inhibitors for at least 2 weeks preceding the study
  • Women with childbearing potential must have negative pregnancy test
  • Women of child bearing potential must agree to use accepted methods of contraception
  • Participant has signed the written informed consent form

Exclusion Criteria:

  • Participants taking Monoamine oxydase (MAO) inhibitors, neuroleptics or drugs for seizures
  • Severe hepatic impairment (the impaired ability of the liver to fulfill its role in metabolism)
  • On maintenance tramadol and/or paracetamol(APAP)
  • On sedative hypnotics, short-acting analgesics, topical medications and anesthetics, and/or muscle relaxants
  • Pregnant, lactating or breastfeeding participants
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Philippines
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01728246
Other Study ID Numbers  ICMJE CR013696
TRAMAPNAP4002
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Janssen Pharmaceutica
Study Sponsor  ICMJE Janssen Pharmaceutica
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Janssen Pharmaceutica Clinical trial Janssen Pharmaceutica
PRS Account Janssen Pharmaceutica
Verification Date February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP