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Trial record 70 of 450 for:    TRAMADOL

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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Osteoarthritis
Interventions Drug: Tramadol/Paracetamol (APAP)
Drug: Non-Tramadol/APAP
Enrollment 473
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Tramadol/Paracetamol (APAP) Non-Tramadol/APAP
Hide Arm/Group Description Celecoxib 200 milligram (mg) administered orally once daily for 4 weeks and fixed dose combination of tramadol 37.5 mg/paracetamol 325 mg administered orally thrice daily for 4 weeks as add-on therapy. Celecoxib 200 mg administered orally once daily for 4 weeks.
Period Title: Overall Study
Started 242 231
Completed 206 195
Not Completed 36 36
Reason Not Completed
Participant needed rescue medication             1             5
Protocol Violation             1             0
Withdrawal by Subject             2             3
Lost to Follow-up             23             22
Lack of Efficacy             1             1
Adverse Event             8             5
Arm/Group Title Tramadol/Paracetamol (APAP) Non-Tramadol/APAP Total
Hide Arm/Group Description Celecoxib 200 milligram (mg) administered orally once daily for 4 weeks and fixed dose combination of tramadol 37.5 mg/paracetamol 325 mg administered orally thrice daily for 4 weeks as add-on therapy. Celecoxib 200 mg administered orally once daily for 4 weeks. Total of all reporting groups
Overall Number of Baseline Participants 242 231 473
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 242 participants 231 participants 473 participants
61.991  (12.084) 62.40  (12.437) 62.19  (12.248)
Sex/Gender, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 242 participants 231 participants 473 participants
Female 171 177 348
Male 69 53 122
Unknown 2 1 3
1.Primary Outcome
Title Change From Baseline in Visual Analogue Scale for Pain (VAS-pain) Score at Week 2
Hide Description 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.
Time Frame Baseline and Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population included all the participants who received at least 1 dose of study medication and had at least 1 post-baseline efficacy assessment.
Arm/Group Title Tramadol/Paracetamol (APAP) Non-Tramadol/APAP
Hide Arm/Group Description:
Celecoxib 200 milligram (mg) administered orally once daily for 4 weeks and fixed dose combination of tramadol 37.5 mg/paracetamol 325 mg administered orally thrice daily for 4 weeks as add-on therapy.
Celecoxib 200 mg administered orally once daily for 4 weeks.
Overall Number of Participants Analyzed 242 231
Mean (Standard Deviation)
Unit of Measure: mm
Baseline 71.86  (13.485) 68.03  (13.77)
Change at Week 2 -29.721  (16.936) -21.972  (12.906)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tramadol/Paracetamol (APAP), Non-Tramadol/APAP
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
2.Primary Outcome
Title Change From Baseline in VAS-pain Score at Week 4
Hide Description 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.
Time Frame Baseline and Week 4 Last Observation Carried Forward (LOCF)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all the participants who received at least 1 dose of study medication and had at least 1 post-baseline efficacy assessment. LOCF method was used.
Arm/Group Title Tramadol/Paracetamol (APAP) Non-Tramadol/APAP
Hide Arm/Group Description:
Celecoxib 200 milligram (mg) administered orally once daily for 4 weeks and fixed dose combination of tramadol 37.5 mg/paracetamol 325 mg administered orally thrice daily for 4 weeks as add-on therapy.
Celecoxib 200 mg administered orally once daily for 4 weeks.
Overall Number of Participants Analyzed 242 231
Mean (Standard Deviation)
Unit of Measure: mm
-45.027  (19.963) -34.266  (15.665)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tramadol/Paracetamol (APAP), Non-Tramadol/APAP
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
3.Primary Outcome
Title Change From Baseline in Oswestry Disability Index (ODI) Score at Week 2
Hide Description 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.
Time Frame Baseline and Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not analyzed at Week 2 as time frame was too short to assess Quality of Life (QOL) by ODI score.
Arm/Group Title Tramadol/Paracetamol (APAP) Non-Tramadol/APAP
Hide Arm/Group Description:
Celecoxib 200 milligram (mg) administered orally once daily for 4 weeks and fixed dose combination of tramadol 37.5 mg/paracetamol 325 mg administered orally thrice daily for 4 weeks as add-on therapy.
Celecoxib 200 mg administered orally once daily for 4 weeks.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Primary Outcome
Title Change From Baseline in ODI Score at Week 4
Hide Description 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.
Time Frame Baseline and Week 4 (LOCF)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all the participants who received at least 1 dose of study medication and had at least 1 post-baseline efficacy assessment. LOCF method was used.
Arm/Group Title Tramadol/Paracetamol (APAP) Non-Tramadol/APAP
Hide Arm/Group Description:
Celecoxib 200 milligram (mg) administered orally once daily for 4 weeks and fixed dose combination of tramadol 37.5 mg/paracetamol 325 mg administered orally thrice daily for 4 weeks as add-on therapy.
Celecoxib 200 mg administered orally once daily for 4 weeks.
Overall Number of Participants Analyzed 242 231
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 58.24  (17.034) 57.23  (16.780)
Change at Week 4 (LOCF) -19.102  (15.103) -15.177  (13.328)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tramadol/Paracetamol (APAP), Non-Tramadol/APAP
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
5.Primary Outcome
Title Percentage of Participants Who Discontinued Because of Rescue Medication
Hide Description 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 Frame Baseline up to Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all the participants who received at least 1 dose of study medication and had at least 1 post-baseline efficacy assessment.
Arm/Group Title Tramadol/Paracetamol (APAP) Non-Tramadol/APAP
Hide Arm/Group Description:
Celecoxib 200 milligram (mg) administered orally once daily for 4 weeks and fixed dose combination of tramadol 37.5 mg/paracetamol 325 mg administered orally thrice daily for 4 weeks as add-on therapy.
Celecoxib 200 mg administered orally once daily for 4 weeks.
Overall Number of Participants Analyzed 242 231
Measure Type: Number
Unit of Measure: percentage of participants
0.41 2.16
6.Primary Outcome
Title Time to Discontinuation Because of Rescue Medication
Hide Description 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 Frame Baseline up to Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Time to discontinuation because of rescue medication was not analyzed, because dates when the rescue medication was given were not properly filled out in the forms, hence the exact time to discontinuation because of rescue medication could not be determined or analyzed.
Arm/Group Title Tramadol/Paracetamol (APAP) Non-Tramadol/APAP
Hide Arm/Group Description:
Celecoxib 200 milligram (mg) administered orally once daily for 4 weeks and fixed dose combination of tramadol 37.5 mg/paracetamol 325 mg administered orally thrice daily for 4 weeks as add-on therapy.
Celecoxib 200 mg administered orally once daily for 4 weeks.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame From signing of informed consent until 30 days after the last dose of study medication
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Tramadol/Paracetamol (APAP) Non-Tramadol/APAP
Hide Arm/Group Description Celecoxib 200 milligram (mg) administered orally once daily for 4 weeks and fixed dose combination of tramadol 37.5 mg/paracetamol 325 mg administered orally thrice daily for 4 weeks as add-on therapy. Celecoxib 200 mg administered orally once daily for 4 weeks.
All-Cause Mortality
Tramadol/Paracetamol (APAP) Non-Tramadol/APAP
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Tramadol/Paracetamol (APAP) Non-Tramadol/APAP
Affected / at Risk (%) Affected / at Risk (%)
Total   1/242 (0.41%)   1/231 (0.43%) 
General disorders     
Severe Hypertension * 1  1/242 (0.41%)  0/231 (0.00%) 
Generalized Body Rashes * 1  1/242 (0.41%)  0/231 (0.00%) 
Dizziness / Nausea * 1  1/242 (0.41%)  0/231 (0.00%) 
Vaginal Bleeding * 1  0/242 (0.00%)  1/231 (0.43%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, No coding system
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Tramadol/Paracetamol (APAP) Non-Tramadol/APAP
Affected / at Risk (%) Affected / at Risk (%)
Total   19/242 (7.85%)   10/231 (4.33%) 
General disorders     
Drowsiness * 1  5/242 (2.07%)  0/231 (0.00%) 
Abdominal Pain * 1  4/242 (1.65%)  1/231 (0.43%) 
Dizziness / Nausea * 1  10/242 (4.13%)  2/231 (0.87%) 
Vertigo * 1  0/242 (0.00%)  2/231 (0.87%) 
Tachycardia * 1  0/242 (0.00%)  1/231 (0.43%) 
Increase Pain * 1  1/242 (0.41%)  0/231 (0.00%) 
Increase Swelling * 1  1/242 (0.41%)  0/231 (0.00%) 
Dyspepsia * 1  0/242 (0.00%)  1/231 (0.43%) 
Vomitting * 1  1/242 (0.41%)  0/231 (0.00%) 
Palpitation * 1  0/242 (0.00%)  1/231 (0.43%) 
Onset of Pain Contralateral to the Reference Point * 1  1/242 (0.41%)  0/231 (0.00%) 
Leg Heaviness * 1  0/242 (0.00%)  1/231 (0.43%) 
Headache * 1  0/242 (0.00%)  1/231 (0.43%) 
Flatulence * 1  1/242 (0.41%)  1/231 (0.43%) 
Cough * 1  0/242 (0.00%)  1/231 (0.43%) 
Chest Tightening * 1  1/242 (0.41%)  0/231 (0.00%) 
Sensation of Heat * 1  0/242 (0.00%)  1/231 (0.43%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, No coding system
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Affairs Manager
Organization: Janssen Pharmaceutica
Phone: +632-8247901
Layout table for additonal information
Responsible Party: Janssen Pharmaceutica
ClinicalTrials.gov Identifier: NCT01728246     History of Changes
Other Study ID Numbers: CR013696
TRAMAPNAP4002
First Submitted: November 13, 2012
First Posted: November 19, 2012
Results First Submitted: December 7, 2012
Results First Posted: January 14, 2013
Last Update Posted: February 12, 2013