Trial Outcomes & Findings for An Efficacy, Safety and Effects on Quality of Life of Tramadol/Paracetamol as Add-on Therapy in Chronic Osteoarthritis (NCT NCT01728246)
NCT ID: NCT01728246
Last Updated: 2013-02-12
Results Overview
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.
COMPLETED
PHASE4
473 participants
Baseline and Week 2
2013-02-12
Participant Flow
Participant milestones
| Measure |
Tramadol/Paracetamol (APAP)
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.
|
Non-Tramadol/APAP
Celecoxib 200 mg administered orally once daily for 4 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
242
|
231
|
|
Overall Study
COMPLETED
|
206
|
195
|
|
Overall Study
NOT COMPLETED
|
36
|
36
|
Reasons for withdrawal
| Measure |
Tramadol/Paracetamol (APAP)
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.
|
Non-Tramadol/APAP
Celecoxib 200 mg administered orally once daily for 4 weeks.
|
|---|---|---|
|
Overall Study
Participant needed rescue medication
|
1
|
5
|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
3
|
|
Overall Study
Lost to Follow-up
|
23
|
22
|
|
Overall Study
Lack of Efficacy
|
1
|
1
|
|
Overall Study
Adverse Event
|
8
|
5
|
Baseline Characteristics
An Efficacy, Safety and Effects on Quality of Life of Tramadol/Paracetamol as Add-on Therapy in Chronic Osteoarthritis
Baseline characteristics by cohort
| Measure |
Tramadol/Paracetamol (APAP)
n=242 Participants
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.
|
Non-Tramadol/APAP
n=231 Participants
Celecoxib 200 mg administered orally once daily for 4 weeks.
|
Total
n=473 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
61.991 years
STANDARD_DEVIATION 12.084 • n=5 Participants
|
62.40 years
STANDARD_DEVIATION 12.437 • n=7 Participants
|
62.19 years
STANDARD_DEVIATION 12.248 • n=5 Participants
|
|
Sex/Gender, Customized
Female
|
171 participants
n=5 Participants
|
177 participants
n=7 Participants
|
348 participants
n=5 Participants
|
|
Sex/Gender, Customized
Male
|
69 participants
n=5 Participants
|
53 participants
n=7 Participants
|
122 participants
n=5 Participants
|
|
Sex/Gender, Customized
Unknown
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 2Population: 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.
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.
Outcome measures
| Measure |
Tramadol/Paracetamol (APAP)
n=242 Participants
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.
|
Non-Tramadol/APAP
n=231 Participants
Celecoxib 200 mg administered orally once daily for 4 weeks.
|
|---|---|---|
|
Change From Baseline in Visual Analogue Scale for Pain (VAS-pain) Score at Week 2
Baseline
|
71.86 mm
Standard Deviation 13.485
|
68.03 mm
Standard Deviation 13.77
|
|
Change From Baseline in Visual Analogue Scale for Pain (VAS-pain) Score at Week 2
Change at Week 2
|
-29.721 mm
Standard Deviation 16.936
|
-21.972 mm
Standard Deviation 12.906
|
PRIMARY outcome
Timeframe: Baseline and Week 4 Last Observation Carried Forward (LOCF)Population: 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.
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.
Outcome measures
| Measure |
Tramadol/Paracetamol (APAP)
n=242 Participants
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.
|
Non-Tramadol/APAP
n=231 Participants
Celecoxib 200 mg administered orally once daily for 4 weeks.
|
|---|---|---|
|
Change From Baseline in VAS-pain Score at Week 4
|
-45.027 mm
Standard Deviation 19.963
|
-34.266 mm
Standard Deviation 15.665
|
PRIMARY outcome
Timeframe: Baseline and Week 2Population: Data was not analyzed at Week 2 as time frame was too short to assess Quality of Life (QOL) by ODI score.
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.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline and Week 4 (LOCF)Population: 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.
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.
Outcome measures
| Measure |
Tramadol/Paracetamol (APAP)
n=242 Participants
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.
|
Non-Tramadol/APAP
n=231 Participants
Celecoxib 200 mg administered orally once daily for 4 weeks.
|
|---|---|---|
|
Change From Baseline in ODI Score at Week 4
Baseline
|
58.24 units on a scale
Standard Deviation 17.034
|
57.23 units on a scale
Standard Deviation 16.780
|
|
Change From Baseline in ODI Score at Week 4
Change at Week 4 (LOCF)
|
-19.102 units on a scale
Standard Deviation 15.103
|
-15.177 units on a scale
Standard Deviation 13.328
|
PRIMARY outcome
Timeframe: Baseline up to Week 4Population: ITT population included all the participants who received at least 1 dose of study medication and had at least 1 post-baseline efficacy assessment.
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.
Outcome measures
| Measure |
Tramadol/Paracetamol (APAP)
n=242 Participants
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.
|
Non-Tramadol/APAP
n=231 Participants
Celecoxib 200 mg administered orally once daily for 4 weeks.
|
|---|---|---|
|
Percentage of Participants Who Discontinued Because of Rescue Medication
|
0.41 percentage of participants
|
2.16 percentage of participants
|
PRIMARY outcome
Timeframe: Baseline up to Week 4Population: 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.
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.
Outcome measures
Outcome data not reported
Adverse Events
Tramadol/Paracetamol (APAP)
Non-Tramadol/APAP
Serious adverse events
| Measure |
Tramadol/Paracetamol (APAP)
n=242 participants at risk
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.
|
Non-Tramadol/APAP
n=231 participants at risk
Celecoxib 200 mg administered orally once daily for 4 weeks.
|
|---|---|---|
|
General disorders
Severe Hypertension
|
0.41%
1/242 • From signing of informed consent until 30 days after the last dose of study medication
|
0.00%
0/231 • From signing of informed consent until 30 days after the last dose of study medication
|
|
General disorders
Generalized Body Rashes
|
0.41%
1/242 • From signing of informed consent until 30 days after the last dose of study medication
|
0.00%
0/231 • From signing of informed consent until 30 days after the last dose of study medication
|
|
General disorders
Dizziness / Nausea
|
0.41%
1/242 • From signing of informed consent until 30 days after the last dose of study medication
|
0.00%
0/231 • From signing of informed consent until 30 days after the last dose of study medication
|
|
General disorders
Vaginal Bleeding
|
0.00%
0/242 • From signing of informed consent until 30 days after the last dose of study medication
|
0.43%
1/231 • From signing of informed consent until 30 days after the last dose of study medication
|
Other adverse events
| Measure |
Tramadol/Paracetamol (APAP)
n=242 participants at risk
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.
|
Non-Tramadol/APAP
n=231 participants at risk
Celecoxib 200 mg administered orally once daily for 4 weeks.
|
|---|---|---|
|
General disorders
Drowsiness
|
2.1%
5/242 • From signing of informed consent until 30 days after the last dose of study medication
|
0.00%
0/231 • From signing of informed consent until 30 days after the last dose of study medication
|
|
General disorders
Abdominal Pain
|
1.7%
4/242 • From signing of informed consent until 30 days after the last dose of study medication
|
0.43%
1/231 • From signing of informed consent until 30 days after the last dose of study medication
|
|
General disorders
Dizziness / Nausea
|
4.1%
10/242 • From signing of informed consent until 30 days after the last dose of study medication
|
0.87%
2/231 • From signing of informed consent until 30 days after the last dose of study medication
|
|
General disorders
Vertigo
|
0.00%
0/242 • From signing of informed consent until 30 days after the last dose of study medication
|
0.87%
2/231 • From signing of informed consent until 30 days after the last dose of study medication
|
|
General disorders
Tachycardia
|
0.00%
0/242 • From signing of informed consent until 30 days after the last dose of study medication
|
0.43%
1/231 • From signing of informed consent until 30 days after the last dose of study medication
|
|
General disorders
Increase Pain
|
0.41%
1/242 • From signing of informed consent until 30 days after the last dose of study medication
|
0.00%
0/231 • From signing of informed consent until 30 days after the last dose of study medication
|
|
General disorders
Increase Swelling
|
0.41%
1/242 • From signing of informed consent until 30 days after the last dose of study medication
|
0.00%
0/231 • From signing of informed consent until 30 days after the last dose of study medication
|
|
General disorders
Dyspepsia
|
0.00%
0/242 • From signing of informed consent until 30 days after the last dose of study medication
|
0.43%
1/231 • From signing of informed consent until 30 days after the last dose of study medication
|
|
General disorders
Vomitting
|
0.41%
1/242 • From signing of informed consent until 30 days after the last dose of study medication
|
0.00%
0/231 • From signing of informed consent until 30 days after the last dose of study medication
|
|
General disorders
Palpitation
|
0.00%
0/242 • From signing of informed consent until 30 days after the last dose of study medication
|
0.43%
1/231 • From signing of informed consent until 30 days after the last dose of study medication
|
|
General disorders
Onset of Pain Contralateral to the Reference Point
|
0.41%
1/242 • From signing of informed consent until 30 days after the last dose of study medication
|
0.00%
0/231 • From signing of informed consent until 30 days after the last dose of study medication
|
|
General disorders
Leg Heaviness
|
0.00%
0/242 • From signing of informed consent until 30 days after the last dose of study medication
|
0.43%
1/231 • From signing of informed consent until 30 days after the last dose of study medication
|
|
General disorders
Headache
|
0.00%
0/242 • From signing of informed consent until 30 days after the last dose of study medication
|
0.43%
1/231 • From signing of informed consent until 30 days after the last dose of study medication
|
|
General disorders
Flatulence
|
0.41%
1/242 • From signing of informed consent until 30 days after the last dose of study medication
|
0.43%
1/231 • From signing of informed consent until 30 days after the last dose of study medication
|
|
General disorders
Cough
|
0.00%
0/242 • From signing of informed consent until 30 days after the last dose of study medication
|
0.43%
1/231 • From signing of informed consent until 30 days after the last dose of study medication
|
|
General disorders
Chest Tightening
|
0.41%
1/242 • From signing of informed consent until 30 days after the last dose of study medication
|
0.00%
0/231 • From signing of informed consent until 30 days after the last dose of study medication
|
|
General disorders
Sensation of Heat
|
0.00%
0/242 • From signing of informed consent until 30 days after the last dose of study medication
|
0.43%
1/231 • From signing of informed consent until 30 days after the last dose of study medication
|
Additional Information
Medical Affairs Manager
Janssen Pharmaceutica
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place