OsteoarthritisPhase 4NCT01728246

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

A Phase 4 study testing Tramadol/Paracetamol (APAP) and Non-Tramadol/APAP in people with Osteoarthritis, run by Janssen Pharmaceutica at 1 site in Philippines.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Osteoarthritis
What is being tested?: Tramadol/Paracetamol (APAP) and Non-Tramadol/APAP
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 473 participants
Where: 1 sitePhilippines
Study dates: Oct 2007to May 2008
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Philippines1 site

Janssen Philippines
Paranaque City, National Capital Region, 1700

Other trials in Philippines

About this study

Official title: A Randomized Controlled Trial on the Efficacy, Safety and Quality of Life Effects of Add-on Tramadol/Paracetamol Combination in Chronic Osteoarthritis

Read the 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.

Conditions: Osteoarthritis
Being tested: Tramadol/Paracetamol (APAP), Non-Tramadol/APAP
Keywords: Osteoarthritis, Celecoxib, Tramadol, Paracetamol
Medical subject headings: Osteoarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Tramadol/Paracetamol (APAP)Drug
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.
Non-Tramadol/APAPDrug
Celecoxib 200 mg alone once daily for 4 weeks.

Study groups in NCT01728246
Study group	Role	What they receive
Tramadol/Paracetamol (APAP)	Experimental	Not described Receives: Drug: Tramadol/Paracetamol (APAP)
Non-Tramadol/APAP	Active comparator	Not described Receives: Drug: Non-Tramadol/APAP

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in Visual Analogue Scale for Pain (VAS-pain) Score at 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.
Measured: Baseline and Week 2
Change From Baseline in VAS-pain Score at 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.
Measured: Baseline and Week 4 Last Observation Carried Forward (LOCF)
Change From Baseline in Oswestry Disability Index (ODI) Score at 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.
Measured: Baseline and Week 2
Change From Baseline in ODI Score at 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.
Measured: Baseline and Week 4 (LOCF)
Percentage of Participants Who Discontinued Because of Rescue Medication
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.
Measured: Baseline up to Week 4
Time to Discontinuation Because of Rescue Medication
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.
Measured: Baseline up to Week 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2007May 2008

First posted19 Nov 2012 (estimated)
Study startOct 2007
Primary completionMay 2008
Study completionMay 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for OsteoarthritisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 473 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01728246
Sponsor's protocol ID: CR013696
Other IDs: TRAMAPNAP4002
Status last verified: Feb 2013
First submitted: 13 Nov 2012
Last updated: 12 Feb 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Osteoarthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized Controlled Trial on the Efficacy, Safety and Quality of Life Effects of Add-on Tramadol/Paracetamol Combination in Chronic Osteoarthritis
ClinicalTrials.gov ID: NCT01728246
Acronym / sponsor ID: CR013696
Conditions: Osteoarthritis
Keywords: Osteoarthritis, Celecoxib, Tramadol, Paracetamol
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 473 participants (actual)
Lead sponsor: Janssen PharmaceuticaIndustry (pharma, biotech, devices)
Study start: Oct 2007
Primary completion: May 2008 (actual)
Study completion: May 2008 (actual)
First posted: 19 Nov 2012 (estimated)
Results: Posted 14 Jan 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Tramadol/Paracetamol (APAP)	Experimental	Drug: Tramadol/Paracetamol (APAP)
Non-Tramadol/APAP	Active comparator	Drug: Non-Tramadol/APAP

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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	Tramadol/Paracetamol (APAP)
Non-Tramadol/APAPCelecoxib 200 mg alone once daily for 4 weeks.	Drug	Non-Tramadol/APAP

Primary outcome

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.

Results and safety

Results posted to the registry on 14 Jan 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Tramadol/Paracetamol (APAP)	242	206
Non-Tramadol/APAP	231	195

Primary outcome: Change From Baseline in Visual Analogue Scale for Pain (VAS-pain) Score at Week 2

Time frame: Baseline and Week 2. Mean (Standard Deviation). Unit: mm

Measure	Tramadol/Paracetamol (APAP) n = 242	Non-Tramadol/APAP n = 231
Baseline	71.86 (13.485)	68.03 (13.77)
Change at Week 2	-29.721 (16.936)	-21.972 (12.906)

Tramadol/Paracetamol (APAP) vs Non-Tramadol/APAP: p <0.05, t-test, 2 sided

Population analysed: 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.

Primary outcome: Change From Baseline in VAS-pain Score at Week 4

Time frame: Baseline and Week 4 Last Observation Carried Forward (LOCF). Mean (Standard Deviation). Unit: mm

Measure	Tramadol/Paracetamol (APAP) n = 242	Non-Tramadol/APAP n = 231
Value	-45.027 (19.963)	-34.266 (15.665)

Tramadol/Paracetamol (APAP) vs Non-Tramadol/APAP: p <0.05, t-test, 2 sided

Population analysed: 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.

Primary outcome: Change From Baseline in Oswestry Disability Index (ODI) Score at Week 2

Time frame: Baseline and Week 2

Population analysed: Data was not analyzed at Week 2 as time frame was too short to assess Quality of Life (QOL) by ODI score.

Primary outcome: Change From Baseline in ODI Score at Week 4

Time frame: Baseline and Week 4 (LOCF). Mean (Standard Deviation). Unit: units on a scale

Measure	Tramadol/Paracetamol (APAP) n = 242	Non-Tramadol/APAP n = 231
Baseline	58.24 (17.034)	57.23 (16.780)
Change at Week 4 (LOCF)	-19.102 (15.103)	-15.177 (13.328)

Tramadol/Paracetamol (APAP) vs Non-Tramadol/APAP: p <0.05, t-test, 2 sided

Population analysed: 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.

Adverse events

Time frame: From signing of informed consent until 30 days after the last dose of study medication. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Tramadol/Paracetamol (APAP)	1 of 242 (0.4%)	19 of 242 (7.9%)	Not reported
Non-Tramadol/APAP	1 of 231 (0.4%)	10 of 231 (4.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Osteoarthritis

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Janssen Pharmaceutica Clinical trial study director

Janssen Pharmaceutica

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Tramadol/Paracetamol (APAP) and Non-Tramadol/APAP in people with Osteoarthritis, run by Janssen Pharmaceutica at 1 site in Philippines.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Philippines. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Jan 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Visual Analogue Scale for Pain (VAS-pain) Score at Week 2 (time frame: Baseline and Week 2). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01728246.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2013.