Trial · NCT01728246
An Efficacy, Safety and Effects on Quality of Life of Tramadol/Paracetamol as Add-on Therapy in Chronic Osteoarthritis
NCT01728246, Phase 4, Completed, Janssen Pharmaceutica; results first posted 2013-01-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. An Efficacy, Safety and Effects on Quality of Life of Tramadol/Paracetamol as Add-on Therapy in Chronic Osteoarthritis. Trials, record NCT01728246. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01728246
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Efficacy, Safety and Effects on Quality of Life of Tramadol/Paracetamol as Add-on Therapy in Chronic Osteoarthritis
- NCT number
- NCT01728246
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 473 participants, actual
- Lead sponsor
- Janssen Pharmaceutica
- Conditions
- Osteoarthritis
- Interventions
- Tramadol/Paracetamol (APAP), Non-Tramadol/APAP
- First posted
- 2012-11-19
- Last updated
- 2013-02-12
- Results first posted
- 2013-01-14
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Visual Analogue Scale for Pain (VAS-pain) Score at Week 2 | 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. |
| Primary | Change From Baseline in VAS-pain Score at Week 4 | 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. |
| Primary | Change From Baseline in Oswestry Disability Index (ODI) Score at Week 2 | 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. |
| Primary | Change From Baseline in ODI Score at Week 4 | 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. |
| Primary | Percentage of Participants Who Discontinued Because of Rescue Medication | 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. |
| Primary | Time to Discontinuation Because of Rescue Medication | 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. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Visual Analogue Scale for Pain (VAS-pain) Score at Week 2 | Baseline and Week 2 | 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. | mm | MEAN |
| PRIMARY | Change From Baseline in VAS-pain Score at Week 4 | Baseline and Week 4 Last Observation Carried Forward (LOCF) | 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. | mm | MEAN |
| PRIMARY | Change From Baseline in Oswestry Disability Index (ODI) Score at Week 2 | Baseline and Week 2 | Data was not analyzed at Week 2 as time frame was too short to assess Quality of Life (QOL) by ODI score. | ||
| PRIMARY | Change From Baseline in ODI Score at Week 4 | Baseline and Week 4 (LOCF) | 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. | units on a scale | MEAN |
| PRIMARY | Percentage of Participants Who Discontinued Because of Rescue Medication | Baseline up to Week 4 | ITT population included all the participants who received at least 1 dose of study medication and had at least 1 post-baseline efficacy assessment. | percentage of participants | NUMBER |
| PRIMARY | Time to Discontinuation Because of Rescue Medication | Baseline up to Week 4 | 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. |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Visual Analogue Scale for Pain (VAS-pain) Score at Week 2 | Tramadol/Paracetamol (APAP) | Baseline | 71.86 | Standard Deviation 13.485 | mm |
| Change From Baseline in Visual Analogue Scale for Pain (VAS-pain) Score at Week 2 | Non-Tramadol/APAP | Baseline | 68.03 | Standard Deviation 13.77 | mm |
| Change From Baseline in Visual Analogue Scale for Pain (VAS-pain) Score at Week 2 | Tramadol/Paracetamol (APAP) | Change at Week 2 | -29.721 | Standard Deviation 16.936 | mm |
| Change From Baseline in Visual Analogue Scale for Pain (VAS-pain) Score at Week 2 | Non-Tramadol/APAP | Change at Week 2 | -21.972 | Standard Deviation 12.906 | mm |
| Change From Baseline in VAS-pain Score at Week 4 | Tramadol/Paracetamol (APAP) | -45.027 | Standard Deviation 19.963 | mm | |
| Change From Baseline in VAS-pain Score at Week 4 | Non-Tramadol/APAP | -34.266 | Standard Deviation 15.665 | mm | |
| Change From Baseline in ODI Score at Week 4 | Tramadol/Paracetamol (APAP) | Baseline | 58.24 | Standard Deviation 17.034 | units on a scale |
| Change From Baseline in ODI Score at Week 4 | Non-Tramadol/APAP | Baseline | 57.23 | Standard Deviation 16.780 | units on a scale |
| Change From Baseline in ODI Score at Week 4 | Tramadol/Paracetamol (APAP) | Change at Week 4 (LOCF) | -19.102 | Standard Deviation 15.103 | units on a scale |
| Change From Baseline in ODI Score at Week 4 | Non-Tramadol/APAP | Change at Week 4 (LOCF) | -15.177 | Standard Deviation 13.328 | units on a scale |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Tramadol/Paracetamol (APAP) | 242 | |
| Overall Study | STARTED | Non-Tramadol/APAP | 231 | |
| Overall Study | COMPLETED | Tramadol/Paracetamol (APAP) | 206 | |
| Overall Study | COMPLETED | Non-Tramadol/APAP | 195 | |
| Overall Study | NOT COMPLETED | Tramadol/Paracetamol (APAP) | 36 | |
| Overall Study | NOT COMPLETED | Non-Tramadol/APAP | 36 |
Source ClinicalTrials.gov
Adverse events42
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Drowsiness | General disorders | Tramadol/Paracetamol (APAP) | 5 | 242 | |
| other | Drowsiness | General disorders | Non-Tramadol/APAP | 0 | 231 | |
| other | Abdominal Pain | General disorders | Tramadol/Paracetamol (APAP) | 4 | 242 | |
| other | Abdominal Pain | General disorders | Non-Tramadol/APAP | 1 | 231 | |
| other | Dizziness / Nausea | General disorders | Tramadol/Paracetamol (APAP) | 10 | 242 | |
| other | Dizziness / Nausea | General disorders | Non-Tramadol/APAP | 2 | 231 | |
| other | Vertigo | General disorders | Tramadol/Paracetamol (APAP) | 0 | 242 | |
| other | Vertigo | General disorders | Non-Tramadol/APAP | 2 | 231 | |
| other | Tachycardia | General disorders | Tramadol/Paracetamol (APAP) | 0 | 242 | |
| other | Tachycardia | General disorders | Non-Tramadol/APAP | 1 | 231 |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Tramadol/Paracetamol (APAP) | ||
| Total, all-cause mortality | Non-Tramadol/APAP | ||
| Total, other adverse events | Tramadol/Paracetamol (APAP) | 19 | 242 |
| Total, other adverse events | Non-Tramadol/APAP | 10 | 231 |
| Total, serious adverse events | Tramadol/Paracetamol (APAP) | 1 | 242 |
| Total, serious adverse events | Non-Tramadol/APAP | 1 | 231 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Tramadol/Paracetamol (APAP) vs Non-Tramadol/APAP: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01728246
GET https://conductscience.org/api/trials/v1/NCT01728246/events?page=2