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| ID | Type | Description | Link |
|---|---|---|---|
| R331333PAI3011 | Other Identifier | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
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| Name | Class |
|---|---|
| Grünenthal GmbH | INDUSTRY |
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The purpose of this trial is to evaluate the effectiveness (level of pain control) and safety of orally administrated tapentadol (CG5503) Extended Release (ER) (base) at doses of 100-250 mg twice daily in patients with moderate to severe chronic pain of the lower back, in comparison with placebo and Oxycodone Controlled Release (CR).
The primary objective of this randomized (study medication assigned to patients by chance), double-blind (neither patient nor investigator knows the study medication), phase III, placebo and active controlled trial is to evaluate the efficacy and safety of orally administered tapentadol (CG5503) Extended Release (ER) (base) at doses 100-250 mg twice daily in patients with moderate to severe chronic pain of the lower back. The study is being conducted for registration and approval of tapentadol (CG5503) in the US and outside US. The trial will consist of five periods: screening (to assess eligibility), washout (3-7 days with determination of baseline pain intensity), titration (of dose over 3 weeks to the optimal individual level), maintenance (investigational drug intake for 12 weeks with adjustments allowed), and follow-up (2 weeks post treatment discontinuation). The study hypothesis is that the study drug will be more effective than placebo in reducing patients' pain intensity. The Secondary objectives include the collection of pharmacokinetic (related to how the body uses the drug) information for dose verification. The trial objectives will be assessed by comparing the baseline pain level to the level of week 12 of the maintenance phase. This will be done by looking at the patient's pain diary information. Titrate tapentadol (CG5503) ER (extended release) in 50 mg steps to patient's optimal dose ranging between 100mg and 250mg twice a day; Oxycodone CR (controlled release) 20mg to 50mg twice a day; Placebo (no active ingredients). All doses of trial treatment will be taken orally with or without food, for a maximum timeframe of 15 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 001 | Experimental | tapentadol (CG5503) ER 50 100 150 200 250 mg twice daily for 15 weeks |
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| 002 | Active Comparator | oxycodone CR 10 20 30 40 50 mg twice daily for 15 weeks |
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| 003 | Placebo Comparator | placebo matching placebo twice daily for 15 weeks |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tapentadol (CG5503) ER | Drug | 50, 100, 150, 200, 250 mg twice daily for 15 weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline of the Average Pain Intensity Based on a 11-point Numerical Rating Scale (NRS) Over the Last Week of the Maintenance Period at Week 12. | For this twice daily pain assessment, the subjects were to indicate the level of pain experienced over the previous 12 hours on an 11-point Numerical Rating Scale (NRS) where a score of 0 indicated "no pain" and a score of 10 indicated "pain as bad as you can imagine". | Baseline and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Brief Pain Inventory (BPI) Total Pain Score Over the Last Week of the Maintenance Period at Week 12. | Total pain score where zero equals "no pain" to ten equals "pain as bad as you can imagine" from 12 week endpoint vs baseline. | Baseline and 12 week endpoint |
| Change From Baseline in Sleep Latency Time in Hours Over the Last Week of the Maintenance Period at Week 12. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24985410 | Derived | Etropolski M, Kuperwasser B, Flugel M, Haufel T, Lange B, Rauschkolb C, Laschewski F. Safety and tolerability of tapentadol extended release in moderate to severe chronic osteoarthritis or low back pain management: pooled analysis of randomized controlled trials. Adv Ther. 2014 Jun;31(6):604-20. doi: 10.1007/s12325-014-0128-6. Epub 2014 Jul 2. | |
| 24916058 |
| Label | URL |
|---|---|
| A Study to Evaluate the Effectiveness and Safety of Tapentadol (R331333) Extended Release (ER) in Patients with Moderate to Severe Chronic Low Back Pain | View source |
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The study consisted of a screening period (duration up to 14 days), a washout period (duration 3 to 7 days), a double-blind active treatment period with titration period (duration 3 weeks) and maintenance period (duration 12 weeks).
The recruitment period for this out-patient, multicenter study occurred between 21 February 2007 and 12 March 2008.
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| ID | Title | Description |
|---|---|---|
| FG000 | Tapentadol ER | Tapentadol (CG5503) extended release(ER) 100-250mg twice daily(BID) |
| FG001 | Oxycodone CR | oxycodone controlled release(CR) 20-50mg twice daily(BID) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| oxycodone CR |
| Drug |
10, 20, 30, 40, 50 mg twice daily for 15 weeks |
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| placebo | Drug | matching placebo twice daily for 15 weeks |
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A Sleep Questionnaire addressed the following question: "How long after bedtime/lights out did you fall asleep last night (hours)?" 12 week endpoint-mean changes from baseline at endpoint for sleep latency. Decrease in time(hours) indicates improvement. |
| Baseline and 12 week endpoint |
| Percentage of Patients Who Reported Very Much Improved or Much Improved From Baseline in Patient Global Impression of Change Over the Last Week of the Maintenance Period at Week 12 | Ordinal measure indicating change from start of treatment (On a scale of 7 = Very much Worse to 1 = very much improved) | Baseline and 12 week endpoint |
| Number of Participants With Treatment Discontinuation Due to Lack of Efficacy | The number of participants who discontinued due to lack of efficacy from baseline to endpoint | Baseline and 12 weeks |
| Change From Baseline in EuroQol-5® (EQ-5D) Health Status Index to Week 12 | Change from baseline to end point in EuroQol-5 Dimension Questionnaire. A higher score indicates an improvement in health in the Health Status Index. The EuroQol-5 is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating "full health" and 0 representing dead. | Baseline and 12 week endpoint |
| Responder Analysis 50% Improvement | Defined by the proportion of subjects achieving at least 50% improvement from baseline in the primary endpoint of change from baseline of the average pain intensity based on the 11-point Numerical Rating Scale (NRS) at week 12. The subjects were to indicate the level of pain experienced over the previous 12 hours on an 11-point NRS where a score of 0 indicated "no pain" and a score of 10 indicated "pain as bad as you can imagine". | Baseline and Week 12 |
| Biondi DM, Xiang J, Etropolski M, Moskovitz B. Evaluation of blood pressure and heart rate in patients with hypertension who received tapentadol extended release for chronic pain: a post hoc, pooled data analysis. Clin Drug Investig. 2014 Aug;34(8):565-76. doi: 10.1007/s40261-014-0209-y. |
| 24353047 | Derived | Etropolski M, Lange B, Goldberg J, Steup A, Rauschkolb C. A pooled analysis of patient-specific factors and efficacy and tolerability of tapentadol extended release treatment for moderate to severe chronic pain. J Opioid Manag. 2013 Sep-Oct;9(5):343-56. doi: 10.5055/jom.2013.0177. |
| 23709304 | Derived | Merchant S, Provenzano D, Mody S, Ho KF, Etropolski M. Composite measure to assess efficacy/gastrointestinal tolerability of tapentadol ER versus oxycodone CR for chronic pain: pooled analysis of randomized studies. J Opioid Manag. 2013 Jan-Feb;9(1):51-61. doi: 10.5055/jom.2013.0147. |
| 23340531 | Derived | Afilalo M, Morlion B. Efficacy of tapentadol ER for managing moderate to severe chronic pain. Pain Physician. 2013 Jan;16(1):27-40. |
| FG002 | Placebo | Matching Placebo twice daily(BID) |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Tapentadol ER | Tapentadol (CG5503) extended release(ER) 100-250mg twice daily(BID) |
| BG001 | Oxycodone CR | oxycodone controlled release(CR) 20-50mg twice daily(BID) |
| BG002 | Placebo | Matching Placebo twice daily(BID) |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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 of the Average Pain Intensity Based on a 11-point Numerical Rating Scale (NRS) Over the Last Week of the Maintenance Period at Week 12. | For this twice daily pain assessment, the subjects were to indicate the level of pain experienced over the previous 12 hours on an 11-point Numerical Rating Scale (NRS) where a score of 0 indicated "no pain" and a score of 10 indicated "pain as bad as you can imagine". | Intent To Treat (ITT) analysis set utilizing Last Observation Carried Forward (LOCF) imputation. The ITT analysis set included all randomized patients that took at least one dose of study medication following randomization. 7 patients (3 tapentadol ER, 3 oxycodone CR, 1 placebo) had no baseline pain scores therefore excluded from the analysis. | Posted | Mean | Standard Deviation | scores on a scale | Baseline and 12 weeks |
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| Secondary | Change From Baseline in Brief Pain Inventory (BPI) Total Pain Score Over the Last Week of the Maintenance Period at Week 12. | Total pain score where zero equals "no pain" to ten equals "pain as bad as you can imagine" from 12 week endpoint vs baseline. | Intent to Treat (ITT) analysis set, last observation carried forward (LOCF) imputation. The ITT analysis set included all randomized patients that took at least one dose of study medication following randomization. The patients who didi not have any assessment during the treatment period were excluded from the analysis. | Posted | Mar 2009 | Mean | Standard Deviation | scores on a scale | Baseline and 12 week endpoint |
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| Secondary | Change From Baseline in Sleep Latency Time in Hours Over the Last Week of the Maintenance Period at Week 12. | A Sleep Questionnaire addressed the following question: "How long after bedtime/lights out did you fall asleep last night (hours)?" 12 week endpoint-mean changes from baseline at endpoint for sleep latency. Decrease in time(hours) indicates improvement. | Intent to Treat population with LOCF imputation. The patients who didi not have any assessment during the treatment period were excluded from the analysis. | Posted | Mar 2009 | Mean | Standard Deviation | hours | Baseline and 12 week endpoint |
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| Secondary | Percentage of Patients Who Reported Very Much Improved or Much Improved From Baseline in Patient Global Impression of Change Over the Last Week of the Maintenance Period at Week 12 | Ordinal measure indicating change from start of treatment (On a scale of 7 = Very much Worse to 1 = very much improved) | Intent to Treat Analysis (ITT) set, Last Observation Carried Forward (LOCF) imputation method. The ITT analysis set included all randomized subjects who took at least one dose of study medication following randomization. The patients who didi not have any assessment during the treatment period were excluded from the analysis. | Posted | Number | percentage of participants | Baseline and 12 week endpoint |
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| Secondary | Number of Participants With Treatment Discontinuation Due to Lack of Efficacy | The number of participants who discontinued due to lack of efficacy from baseline to endpoint | Intent to Treat Analysis Set | Posted | Mar 2009 | Number | participants | Baseline and 12 weeks |
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| Secondary | Change From Baseline in EuroQol-5® (EQ-5D) Health Status Index to Week 12 | Change from baseline to end point in EuroQol-5 Dimension Questionnaire. A higher score indicates an improvement in health in the Health Status Index. The EuroQol-5 is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating "full health" and 0 representing dead. | Intent to Treat Analysis Set, LOCF imputation method. The patients who didi not have any assessment during the treatment period were excluded from the analysis. | Posted | Mar 2009 | Mean | Standard Deviation | scores on a scale | Baseline and 12 week endpoint |
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| Secondary | Responder Analysis 50% Improvement | Defined by the proportion of subjects achieving at least 50% improvement from baseline in the primary endpoint of change from baseline of the average pain intensity based on the 11-point Numerical Rating Scale (NRS) at week 12. The subjects were to indicate the level of pain experienced over the previous 12 hours on an 11-point NRS where a score of 0 indicated "no pain" and a score of 10 indicated "pain as bad as you can imagine". | Intent to Treat Analysis Set | Posted | Mar 2009 | Number | Percentage of participants | Baseline and Week 12 |
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All adverse events were reported from the time a signed and dated informed consent was obtained throughout the follow-up phase of the study. Serious adverse events were collected for 30 days after the last dose of study drug.
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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 | Tapentadol ER | Tapentadol (CG5503) extended release(ER) 100-250mg twice daily(BID) | 8 | 192 | 318 | |||
| EG001 | Oxycodone CR | oxycodone controlled release(CR) 20-50mg twice daily(BID) | 11 | 240 | 328 | |||
| EG002 | Placebo | Matching Placebo twice daily(BID) | 3 | 118 | 319 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain | Gastrointestinal disorders | MedDRA 10.1 | Non-systematic Assessment |
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| Anemia | Blood and lymphatic system disorders | MedDRA 10.1 | Non-systematic Assessment |
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| Angina Pectoris | Cardiac disorders | MedDRA 10.1 | Non-systematic Assessment |
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| Atrial Fibrillation | Cardiac disorders | MedDRA 10.1 | Non-systematic Assessment |
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| Bipolar Disorder | Psychiatric disorders | MedDRA 10.1 | Non-systematic Assessment |
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| Bladder Cancer Recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.1 | Non-systematic Assessment |
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| Cardiac Pacemaker Replacement | Surgical and medical procedures | MedDRA 10.1 | Non-systematic Assessment |
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| Chest Pain | General disorders | MedDRA 10.1 | Non-systematic Assessment |
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| Clostridial Infection | Infections and infestations | MedDRA 10.1 | Non-systematic Assessment |
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| Confusional State | Psychiatric disorders | MedDRA 10.1 | Non-systematic Assessment |
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| Coronary Artery Bypass | Surgical and medical procedures | MedDRA 10.1 | Non-systematic Assessment |
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| Coronary Artery Occlusion | Cardiac disorders | MedDRA 10.1 | Non-systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA 10.1 | Non-systematic Assessment |
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| Depressed Level of Consciousness | Nervous system disorders | MedDRA 10.1 | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 10.1 | Non-systematic Assessment |
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| Duodenal Ulcer | Gastrointestinal disorders | MedDRA 10.1 | Non-systematic Assessment |
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| Foot Fracture | Injury, poisoning and procedural complications | MedDRA 10.1 | Non-systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 10.1 | Non-systematic Assessment |
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| Gastroesophageal Reflux Disease | Gastrointestinal disorders | MedDRA 10.1 | Non-systematic Assessment |
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| Injury | Injury, poisoning and procedural complications | MedDRA 10.1 | Non-systematic Assessment |
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| Non Cardiac Chest Pain | General disorders | MedDRA 10.1 | Non-systematic Assessment |
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| Palpitations | Cardiac disorders | MedDRA 10.1 | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 10.1 | Non-systematic Assessment |
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| Schizoaffective Disorder | Psychiatric disorders | MedDRA 10.1 | Non-systematic Assessment |
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| Schizophrenia | Psychiatric disorders | MedDRA 10.1 | Non-systematic Assessment |
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| Suicidal Ideation | Psychiatric disorders | MedDRA 10.1 | Non-systematic Assessment |
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| Tinnitus | Ear and labyrinth disorders | MedDRA 10.1 | Non-systematic Assessment |
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| Transient Ischemic Attack | Nervous system disorders | MedDRA 10.1 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA 10.1 | Non-systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | MedDRA 10.1 | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 10.1 | Non-systematic Assessment |
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| Dry Mouth | Gastrointestinal disorders | MedDRA 10.1 | Non-systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA 10.1 | Non-systematic Assessment |
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| Fatigue | General disorders | MedDRA 10.1 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 10.1 | Non-systematic Assessment |
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| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 10.1 | Non-systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 10.1 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 10.1 | Non-systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 10.1 | Non-systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA 10.1 | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 10.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Director, Clinical Leader | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | 609-730-4537 |
| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077432 | Tapentadol |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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