- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef 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 april 2012 bijgewerkt door: Labopharm Inc.
The purpose of this study is to compare the analgesic efficacy, safety and clinical benefit of Tramadol OAD tablets versus Placebo.
Studie Overzicht
Toestand
Voltooid
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Werkelijk)
1028
Fase
- Fase 3
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
40 jaar tot 80 jaar (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verviervoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Placebo-vergelijker: 2 Placebo's
|
|
Experimenteel: 1 Tramadol Once A Day
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
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)
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Pain Intensity Score (11-point PINRS) After 6 Weeks of Maintenance Treatment
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 12 weeks
|
The number of patients who discontinued due to lack of efficacy was reported.
|
12 weeks
|
Discontinuation Due to Adverse Events
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Nuttige links
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 oktober 2004
Primaire voltooiing (Werkelijk)
1 januari 2006
Studie voltooiing (Werkelijk)
1 januari 2006
Studieregistratiedata
Eerst ingediend
29 januari 2009
Eerst ingediend dat voldeed aan de QC-criteria
30 januari 2009
Eerst geplaatst (Schatting)
2 februari 2009
Updates van studierecords
Laatste update geplaatst (Schatting)
30 april 2012
Laatste update ingediend die voldeed aan QC-criteria
25 april 2012
Laatst geverifieerd
1 april 2012
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- MDT3-005
- NCT00833794 (Register-ID: ClinicalTrials.gov)
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
Klinische onderzoeken op Placebo
-
SamA Pharmaceutical Co., LtdOnbekendAcute bronchitis | Acute bovenste luchtweginfectieKorea, republiek van
-
National Institute on Drug Abuse (NIDA)VoltooidCannabisgebruikVerenigde Staten
-
AstraZenecaParexel; Spandauer Damm 130; 14050; Berlin, GermanyVoltooidMannelijke proefpersonen met diabetes type II (T2DM)Duitsland
-
Heptares Therapeutics LimitedVoltooidFarmacokinetiek | Veiligheid problemenVerenigd Koninkrijk
-
Soroka University Medical CenterVoltooid
-
Regado Biosciences, Inc.VoltooidGezonde vrijwilligerVerenigde Staten
-
Texas A&M UniversityNutraboltVoltooidGlucose and Insulin Response
-
Longeveron Inc.BeëindigdHypoplastisch linkerhartsyndroomVerenigde Staten
-
ItalfarmacoVoltooidBecker spierdystrofieNederland, Italië