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

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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

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).

Condition or disease Intervention/treatment Phase
Osteoarthritis Drug: Tramadol/Paracetamol (APAP) Drug: Non-Tramadol/APAP Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 473 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial on the Efficacy, Safety and Quality of Life Effects of Add-on Tramadol/Paracetamol Combination in Chronic Osteoarthritis
Study Start Date : October 2007
Actual Primary Completion Date : May 2008
Actual Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis
Drug Information available for: Tramadol

Arm Intervention/treatment
Experimental: Tramadol/Paracetamol (APAP) 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.

Active Comparator: Non-Tramadol/APAP Drug: Non-Tramadol/APAP
Celecoxib 200 mg alone once daily for 4 weeks.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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): NCT01728246


Locations
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Philippines
Janssen Philippines
Paranaque City, Metro Manila, Philippines, 1700
Sponsors and Collaborators
Janssen Pharmaceutica
Investigators
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Study Director: Janssen Pharmaceutica Clinical trial Janssen Pharmaceutica

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Responsible Party: Janssen Pharmaceutica
ClinicalTrials.gov Identifier: NCT01728246     History of Changes
Other Study ID Numbers: CR013696
TRAMAPNAP4002
First Posted: November 19, 2012    Key Record Dates
Results First Posted: January 14, 2013
Last Update Posted: February 12, 2013
Last Verified: February 2013

Keywords provided by Janssen Pharmaceutica:
Osteoarthritis
Celecoxib
Tramadol
Paracetamol

Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Acetaminophen
Celecoxib
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 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Narcotics
Central Nervous System Depressants