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| ID | Type | Description | Link |
|---|---|---|---|
| TRAMAPNAP4002 |
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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).
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tramadol/Paracetamol (APAP) | Experimental |
| |
| Non-Tramadol/APAP | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | Baseline and Week 4 (LOCF) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Pharmaceutica Clinical trial | Janssen Pharmaceutica | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Janssen Philippines | Paranaque City | National Capital Region | 1700 | Philippines |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Non-Tramadol/APAP | Celecoxib 200 mg administered orally once daily for 4 weeks. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Non-Tramadol/APAP |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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. | Posted | Mean | Standard Deviation | mm | Baseline and Week 2 |
|
From signing of informed consent until 30 days after the last dose of study medication
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Severe Hypertension | General disorders | No coding system | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Drowsiness | General disorders | No coding system | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Affairs Manager | Janssen Pharmaceutica | +632-8247901 |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D014147 | Tramadol |
| D000082 | Acetaminophen |
| ID | Term |
|---|---|
| D003511 | Cyclohexanols |
| D000441 | Hexanols |
| D005233 | Fatty Alcohols |
| D000438 | Alcohols |
| D009930 |
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| Non-Tramadol/APAP | Drug | Celecoxib 200 mg alone once daily for 4 weeks. |
|
| 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. | 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. | Baseline up to Week 4 |
| Withdrawal by Subject |
|
| Lost to Follow-up |
|
| Lack of Efficacy |
|
| Adverse Event |
|
Celecoxib 200 mg administered orally once daily for 4 weeks. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Number | participants |
|
| OG001 | Non-Tramadol/APAP | Celecoxib 200 mg administered orally once daily for 4 weeks. |
|
|
|
| Primary | 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. | 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. | Posted | Mean | Standard Deviation | mm | Baseline and Week 4 Last Observation Carried Forward (LOCF) |
|
|
|
|
| Primary | 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. | Data was not analyzed at Week 2 as time frame was too short to assess Quality of Life (QOL) by ODI score. | Posted | Baseline and Week 2 |
|
|
| Primary | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline and Week 4 (LOCF) |
|
|
|
|
| Primary | 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. | ITT population included all the participants who received at least 1 dose of study medication and had at least 1 post-baseline efficacy assessment. | Posted | Number | percentage of participants | Baseline up to Week 4 |
|
|
|
| Primary | 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. | 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. | Posted | Baseline up to Week 4 |
|
|
| 1 |
| 242 |
| 19 |
| 242 |
| EG001 | Non-Tramadol/APAP | Celecoxib 200 mg administered orally once daily for 4 weeks. | 1 | 231 | 10 | 231 |
| Generalized Body Rashes | General disorders | No coding system | Non-systematic Assessment |
|
| Dizziness / Nausea | General disorders | No coding system | Non-systematic Assessment |
|
| Vaginal Bleeding | General disorders | No coding system | Non-systematic Assessment |
|
| Abdominal Pain | General disorders | No coding system | Non-systematic Assessment |
|
| Dizziness / Nausea | General disorders | No coding system | Non-systematic Assessment |
|
| Vertigo | General disorders | No coding system | Non-systematic Assessment |
|
| Tachycardia | General disorders | No coding system | Non-systematic Assessment |
|
| Increase Pain | General disorders | No coding system | Non-systematic Assessment |
|
| Increase Swelling | General disorders | No coding system | Non-systematic Assessment |
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| Dyspepsia | General disorders | No coding system | Non-systematic Assessment |
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| Vomitting | General disorders | No coding system | Non-systematic Assessment |
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| Palpitation | General disorders | No coding system | Non-systematic Assessment |
|
| Onset of Pain Contralateral to the Reference Point | General disorders | No coding system | Non-systematic Assessment |
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| Leg Heaviness | General disorders | No coding system | Non-systematic Assessment |
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| Headache | General disorders | No coding system | Non-systematic Assessment |
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| Flatulence | General disorders | No coding system | Non-systematic Assessment |
|
| Cough | General disorders | No coding system | Non-systematic Assessment |
|
| Chest Tightening | General disorders | No coding system | Non-systematic Assessment |
|
| Sensation of Heat | General disorders | No coding system | Non-systematic Assessment |
|
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| Organic Chemicals |
| D004123 | Dimethylamines |
| D008744 | Methylamines |
| D000588 | Amines |
| D008055 | Lipids |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D000814 | Aniline Compounds |