- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00421928
Tapentadol (CG5503)
16 april 2012 uppdaterad av: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
A Randomized Double-Blind, Placebo- and Active-Control, Parallel-arm, Phase III Trial With Controlled Adjustment of Dose to Evaluate the Efficacy and Safety of CG5503 Extended-Release (ER) in Patients With Moderate to Severe Chronic Pain Due to Osteoarthritis of the Knee
The purpose of this trial is to evaluate the effectiveness (level of pain control) and safety of orally administered tapentadol (CG5503) Extended Release (ER) (base) at doses of 100-250 mg twice daily in patients with moderate to severe chronic pain due to osteoarthritis of the knee, in comparison with placebo and Oxycodone Controlled Release (CR).
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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 of 100-250 mg twice daily in patients with moderate to severe chronic pain from osteoarthritis (OA) of the knee.
The study is being conducted for registration and approval of tapentadol (CG5503) in the US and outside the US.
The trial will consist of five periods: screening (to assess eligibility) , washout (3-7 days with determination of a 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) 50mg to patient's optimal dose ranging between 100mg and 250mg twice a day; Oxycodone CR (controlled release) 10mg to 50mg twice a day; Placebo (no active ingredients).
All doses of trial treatment will be taken orally with approximately 120 mL of water with or without food for a maximum timeframe of 15 weeks.
Studietyp
Interventionell
Inskrivning (Faktisk)
1030
Fas
- Fas 3
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
40 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- Patients diagnosed with osteoarthritis of the knee based on the American College of Rheumatology (ACR) criteria and functional capacity class of I-III
- patients taking analgesic medications for at least 3 months prior to screening and/or dissatisfied with their current therapy
- Patients requiring opioid treatment must be taking daily doses of opioid-based analgesic, equivalent to <160 mg of oral morphine
- baseline score of greater than or equal to 5 on an 11-point numerical rating scale, calculated as the average pain intensity during the last 3 days prior to randomization.
Exclusion Criteria:
- History of alcohol and/or drug abuse in Investigator's judgement
- history of significant liver insufficiency
- chronic hepatitis B or C, or HIV, presence of active hepatitis B or C within the past 3 months
- life-long history of seizure disorder or epilepsy
- history of malignancy within past 2 years, with exception of basal cell carcinoma that has been successfully treated
- uncontrolled hypertension
- patients with severely impaired renal function
- patients with moderate to severly impaired hepatic function or with laboratory values reflecting inadequate hepatic function
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: 001
tapentadol (CG5503) 50 100 150 200 250mg twice a day (BID) during 15 weeks
|
50, 100, 150, 200, 250mg twice a day (BID) during 15 weeks
|
Aktiv komparator: 002
oxycodone 10 20 30 40 50mg twice a day (BID) during 15 weeks
|
10, 20, 30, 40, 50mg twice a day (BID) during 15 weeks
|
Placebo-jämförare: 003
placebo matching placebo twice a day (BID) during 15 weeks
|
matching placebo twice a day (BID) during 15 weeks
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Change From Baseline of the Average Pain Intensity Based on an 11-point Numerical Rating Scale(NRS) Over the Last Week of the Maintenance Period at Week 12.
Tidsram: Baseline and 12 weeks (Primary endpoint is the average pain intensity score during the last week of the maintenance period).
|
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 (Primary endpoint is the average pain intensity score during the last week of the maintenance period).
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Change From Baseline in Western Ontario McMaster Questionnaire (WOMAC) Assessing Pain, Disability and Joint Stiffness of the Knee Over the Last Week of the Maintenance Period at Week 12
Tidsram: Baseline and 12 week endpoint
|
Change from baseline to Week 12 of WOMAC Global Score: WOMAC is measure with a Likert ordinal scale from 0-4 with lower scores indicating lower levels of symptoms or physical disability
|
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.
Tidsram: Baseline and 12 week endpoint
|
A Sleep Questionniare 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
Tidsram: Baseline and 12 week endpoint
|
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
|
Distribution of Time to Treatment Discontinuation Due to Lack of Efficacy
Tidsram: Baseline to 12 weeks
|
The median time to treatment discontinuation due to lack of efficacy from baseline to endpoint
|
Baseline to 12 weeks
|
Change From Baseline in EuroQol-5 (EQ-5D) Health Status Index to Week 12
Tidsram: Baseline and 12 week endpoint
|
Change from baseline to end point in EuroQol-5 (EQ-5D) Dimension Questionnaire.
A higher score indicates an improvement in health in the Health Status Index.
The EQ-5D 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
|
Change From Baseline in Responder Analysis 50% Improvement to Week 12
Tidsram: Baseline and Week 12
|
Defined by the percentage of subjects achieving at least 50% improvement from baseline in the primary endpoint based on the 11-point NRS 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 Week 12
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Samarbetspartners
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- 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.
- Afilalo M, Morlion B. Efficacy of tapentadol ER for managing moderate to severe chronic pain. Pain Physician. 2013 Jan;16(1):27-40.
- 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.
- 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.
- 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.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 januari 2007
Primärt slutförande (Faktisk)
1 juli 2008
Avslutad studie (Faktisk)
1 december 2008
Studieregistreringsdatum
Först inskickad
12 januari 2007
Först inskickad som uppfyllde QC-kriterierna
12 januari 2007
Första postat (Uppskatta)
15 januari 2007
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
18 april 2012
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
16 april 2012
Senast verifierad
1 april 2012
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Ledsjukdomar
- Muskuloskeletala sjukdomar
- Reumatiska sjukdomar
- Artrit
- Artros
- Artros, knä
- Läkemedels fysiologiska effekter
- Adrenerga medel
- Neurotransmittormedel
- Molekylära mekanismer för farmakologisk verkan
- Depressiva medel i centrala nervsystemet
- Agenter från det perifera nervsystemet
- Analgetika
- Sensoriska systemagenter
- Analgetika, Opioid
- Narkotika
- Neurotransmittorupptagshämmare
- Membrantransportmodulatorer
- Adrenerga upptagshämmare
- Oxikodon
- Tapentadol
Andra studie-ID-nummer
- CR013402
- R331333PAI3008 (Annan identifierare: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.)
- KF11 (Annan identifierare: Grunenthal GMBH)
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
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