- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT00833794
A Two-Arm Study Comparing the Analgesic Efficacy and Safety of Tramadol HCl Once-a-Day Versus Placebo for the Treatment of Pain Due to Osteoarthritis
25. dubna 2012 aktualizováno: Labopharm Inc.
The purpose of this study is to compare the analgesic efficacy, safety and clinical benefit of Tramadol OAD tablets versus Placebo.
Přehled studie
Postavení
Dokončeno
Podmínky
Intervence / Léčba
Typ studie
Intervenční
Zápis (Aktuální)
1028
Fáze
- Fáze 3
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
40 let až 80 let (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Popis
Inclusion Criteria for Open-Label phase:
- Males or females
- Must be between the ages of 40-80
Must meet the American College of Rheumatology (ACR) Clinical Classification Criteria for Osteoarthritis of the Knee:
- Current knee pain
- Less than 30 minutes of morning stiffness with or without crepitus on active motion
- Confirmation either by arthroscopy or radiologist's report (X-rays showing osteophytes, joint space narrowing or subchondral bone sclerosis {eburnation}) within five years prior to entry into the study
- Must have a history of exposure to treatment (for pain due to osteoarthritis (OA) of the knee) with Non-steroidal anti-inflammatory drugs (NSAIDs), COX II inhibitors or tramadol.
- Must be taking one of the above medications on a regular basis in the 30 days prior to Visit 2 (S0).
Must meet the following criteria for severity of pain at Visit 2 (Day S0):
- Have a score of ≥ 4 on the 11-point Numerical Rating Scale (PI-NRS; range: 0-10)
- Have a total increase of ≥ 2 points on the 11-point Numerical Rating Scale (range: 0-10) compared to the rating at Visit 1 (Day SX)
- Must have a erythrocyte sedimentation rate (ESR) < 40 mm/hr
- Must have oral and written language comprehension at a level sufficient to comply with the protocol and complete study-related materials
- Must have signed and dated an approved written Informed Consent form in French, Spanish, English or Romanian, which has also been signed and dated by the Investigator (unless otherwise required by the ethics committee), prior to study participation
Exclusion Criteria for Open-Label phase:
- Has known rheumatoid arthritis or any other rheumatic disease
- Has secondary arthritis i.e. any of the following: septic arthritis; inflammatory joint disease; gout; pseudogout; Paget's disease; target joint fracture; acromegaly; fibromyalgia; Wilson's disease; Ochronosis; Haemochromatosis; Osteochondromatosis; heritable arthritic disorders; or collagen gene mutations
- Has a history of bursitis of the knee (target knee)
- Has a history of pain in the ipsilateral hip (target knee)
- Has had a meniscal tear in the target knee within the last 12 months
- Has had cartilage reconstruction procedure in the target knee
- Has had a therapeutic arthroscopy procedure in the target knee within the last 12 months
- Has a Body Mass Index (BMI) greater than 37
- Has had a major illness, requiring hospitalisation during the 3 months before commencement of the screening period
- Is unwilling to stop taking pain medication other than the study medication (for arthritis or other types of pain) or is unwilling to stop taking other medications for the treatment of OA
- Has previously failed treatment with tramadol or discontinued treatment with tramadol due to adverse events
- Has been taking other opioids (e.g. codeine, oxycodone, hydromorphone, etc.) for treatment of OA or other chronic conditions
- Has received Corticosteroid Injections in the target knee within the last 3 months or Viscous injections in the target knee within the last 6 months
- Has had treatment within the last 3 weeks with any of the following medications: monoamine oxidase inhibitors; tricyclic antidepressants and other tricyclic compounds (e.g. cyclobenzaprine, promethazine); neuroleptics; selective serotonin reuptake inhibitors; serotonin-norepinephrine reuptake inhibitors or any other drug that reduces seizure threshold
- Has had treatment with another investigational agent within the last 30 days
- Has a history of seizure disorder other than Infantile Febrile Seizures
- Has a previous or current opioid dependency
- Has a bowel disease causing malabsorption
- Is pregnant, lactating or of childbearing potential and is unwilling to utilise a medically approved method of contraception during participation in this clinical trial
- Has significant liver disease, defined as active hepatitis or elevated liver enzymes >3 times the upper boundary of the normal range
- Has significant renal disease (defined as creatinine clearance <30 mL/min
- Has a history of current or past substance abuse or dependence, other than nicotine
- Has a known and documented allergy to tramadol or any structurally similar drugs (e.g. opiates)
- Has a known and documented allergy to acetaminophen or any structurally similar drugs
- Has any other condition that, in the opinion of the Investigators, would adversely affect the patient's ability to complete the study or its measures.
Inclusion criteria for the double-blinded phase:
- Patients must continue to meet the open-label eligibility criteria and
- Must have a score of ≥ 4 on the Numerical Rating Scale (NRS) with a total increase of ≥ 2 points on the NRS compared to Visit 3(Day R14) and
- Must not have taken any of the prohibited medications during the Open-label Phase.
Exclusion criteria for the double-blinded phase:
- Patient Request
- Adverse Events that contraindicate further administration of the study medication
- Any other situation where in the opinion of the Investigator continued participation in the study would not be in the patient's best interest.
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Čtyřnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
---|---|
Komparátor placeba: 2 Placebo
|
|
Experimentální: 1 Tramadol Once A Day
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Pain Intensity Score as Measured by the 11-point Pain Intensity-Numerical Rating Scale Score at the End of the Study (Week 12 or Time of Discontinuation)
Časové okno: 12 weeks
|
The Pain Intensity Score is an 11-point pain intensity numerical rating scale ranging from 0: no pain to 10: worst possible pain.
The mean score at the end of the study (week 12 or time of discontinuation) was calculated.
|
12 weeks
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Pain Intensity Score (11-point PINRS) After 6 Weeks of Maintenance Treatment
Časové okno: 6 weeks
|
The Pain Intensity Score is an 11-point pain intensity numerical rating scale ranging from 0: no pain to 10: worst possible pain
|
6 weeks
|
Pain Intensity Score Stratified by Dose, at the End of the Study (Week 12 or Time of Discontinuation)
Časové okno: 12 weeks
|
Pain Intensity Score (an 11-point pain intensity numerical rating scale ranging from 0: no pain to 10: worst possible pain) was stratified by final dose level, at week 12 or time of discontinuation.
The final optimum dose level based upon efficacy and tolerability was kept for the entire study.
The mean score was calculated.
|
12 weeks
|
WOMAC Pain Subscale Score at the End of the Study (Week 12 or Time of Discontinuation)
Časové okno: 12 weeks
|
Mean WOMAC Pain Subscale score at week 12.
The WOMAC scale is a 24-item questionnaire divided in 3 subscales, using a 5-point Likert-scale ranging from no difficulty to extreme difficulty (0-none; 1-slight; 2-moderate; 3-severe; 4-extreme).
The WOMAC pain subscale results from the sum of 5 pain questions.
The maximum total score is 20.
|
12 weeks
|
WOMAC Physical Function Subscale Score at the End of the Study (Week 12 or Time of Discontinuation)
Časové okno: 12 weeks
|
Mean WOMAC Physical Function Subscale score at week 12.
The WOMAC scale is a 24-item questionnaire divided in 3 subscales, using a 5-point Likert-scale ranging from no difficulty to extreme difficulty (0-none; 1-slight; 2-moderate; 3-severe; 4-extreme).
The WOMAC Physical Function subscale results from the sum of 17 physical function questions and the maximum possible score is 68.
|
12 weeks
|
Patient Global Impression of Change at the End of the Study (Week 12 or Time of Discontinuation)
Časové okno: 12 weeks
|
This assessment of overall status integrates the effect of the treatment on pain, side effects, and the patient's expectation of pain relief.
It is made using a 7-point categorical scale (1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; 7 = very much worse)
|
12 weeks
|
Physician Global Impression of Change at the End of the Study (Week 12 or Time of Discontinuation)
Časové okno: week 12
|
This assessment of overall impression of study drug is made using a 7-point categorical scale (1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; 7 = very much worse)
|
week 12
|
Time to Response
Časové okno: 12 weeks
|
Response was defined as a decrease of ≥1 point in an 11-point PINRS (11-point pain intensity numerical rating scale ranging from 0: no pain to 10: worst possible pain) from baseline to the last visit.
The time to response was estimated using Kaplan-Meier analysis and a 95% CI for the median time was calculated.
|
12 weeks
|
Discontinuation Due to Lack of Efficacy
Časové okno: 12 weeks
|
The number of patients who discontinued due to lack of efficacy was reported.
|
12 weeks
|
Discontinuation Due to Adverse Events
Časové okno: 12 weeks
|
The number of patients who discontinued due to adverse events (AEs).
An AE is defined as any untoward medical event that occurs during the course of a clinical investigation in which a patient is administered a pharmaceutical or other therapeutic product.
Its occurrence does not necessarily imply a causal relationship with the treatment.
|
12 weeks
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Užitečné odkazy
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia
1. října 2004
Primární dokončení (Aktuální)
1. ledna 2006
Dokončení studie (Aktuální)
1. ledna 2006
Termíny zápisu do studia
První předloženo
29. ledna 2009
První předloženo, které splnilo kritéria kontroly kvality
30. ledna 2009
První zveřejněno (Odhad)
2. února 2009
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
30. dubna 2012
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
25. dubna 2012
Naposledy ověřeno
1. dubna 2012
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- MDT3-005
- NCT00833794 (Identifikátor registru: ClinicalTrials.gov)
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
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