Evaluación de la efectividad y la tolerabilidad de clorhidrato de tapentadol de liberación prolongada y de clorhidrato de tapentadol de liberación inmediata a demanda en pacientes con dolor crónico severo no controlado debido a artrosis de rodilla no tratados con regularidad o en tratamiento con analgésicos de los escalones I o II de la clasificación de la OMS.

• Register: EUCTR
• Last refreshed on: 28 February 2019
• Main ID: EUCTR2009-010423-58-ES
• Date of registration: 03/06/2009
• Prospective Registration: Yes
• Primary sponsor: Grünenthal GmbH
• Public title: Evaluación de la efectividad y la tolerabilidad de clorhidrato de tapentadol de liberación prolongada y de clorhidrato de tapentadol de liberación inmediata a demanda en pacientes con dolor crónico severo no controlado debido a artrosis de rodilla no tratados con regularidad o en tratamiento con analgésicos de los escalones I o II de la clasificación de la OMS.
• Scientific title: Evaluación de la efectividad y la tolerabilidad de clorhidrato de tapentadol de liberación prolongada y de clorhidrato de tapentadol de liberación inmediata a demanda en pacientes con dolor crónico severo no controlado debido a artrosis de rodilla no tratados con regularidad o en tratamiento con analgésicos de los escalones I o II de la clasificación de la OMS.
• Date of first enrolment: 22/07/2009
• Target sample size: 180
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-010423-58
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: Open: Single blind: Double blind: Parallel group: Cross over: Other: If controlled, specify comparator, Other Medicinial Product: Placebo: Other:
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

France, Germany, Spain, United Kingdom

Key inclusion & exclusion criteria

Inclusion criteria:
Key inclusion criteria (general)
Subjects have signed an Informed Consent Form indicating that they understand the purpose of and the procedures required for the trial and are willing to participate in it.
Subjects are men or non-pregnant, non-lactating women. Sexually active women must be postmenopausal, surgically sterile, or practicing an effective method of birth control (e.g., prescription oral contraceptives, contraceptive injections, intrauterine device, double barrier method, contraceptive patch, male partner sterilization) before entry and throughout the trial. Women of childbearing potential must have a negative pregnancy test at screening.
Subjects must be appropriately communicative to verbalize and to differentiate with regard to location and intensity of the pain.

Key inclusion criteria (trial specific) - at the Screening Visit
Subjects must be at least 40 years of age.
Subjects must have a diagnosis of osteoarthritis of the knee based on the American College of Rheumatology (ACR) classification criteria:
Knee pain and Radiographic osteophytes or Knee pain and Aged 40 years or above, and Morning stiffness of 30 minutes of duration or more, and Crepitus on motion.
Subjects must have pain at the reference joint which has been present for at least 3 months.
Subject?s pain must require a strong analgesic (defined as WHO Step III) as judged by the Investigator.
Subjects must report a rate of satisfaction with their previous analgesic regimen not exceeding ?fair? on a subject satisfaction with treatment scale (5-point VRS).
If under regular, daily pretreatment:
? Subjects must be taking a WHO Step I or Step II analgesic medication for osteoarthritis of the knee on a daily basis for at least 2 weeks prior to the Screening Visit.
? The Investigator considers dose increase of WHO Step I analgesics (as mono- or combination therapy) and/or continuation with or dose increase of WHO Step II analgesics inadequate for the individual subject, whatever applicable.
? Subjects must have an average pain intensity score (NRS 3) greater than 5 points during the last 3 days prior to the Screening Visit.
or
If no regular analgesic pretreatment is reported:
Subjects must have an average pain intensity score (NRS-3) greater than 6 points in the last 3 days prior to the Screening Visit and related to osteoarthritis.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
Key exclusion criteria (general)
Presence of a clinically significant disease or laboratory findings that in the Investigator?s opinion may affect efficacy or safety assessments.
Presence of active systemic or local infection, that may, in the opinion of the Investigator, affect the efficacy, quality of life/function or safety assessments.
History of alcohol or drug abuse, or suspicion thereof in the Investigator?s judgment.
Presence of concomitant autoimmune inflammatory conditions.
Known history of or laboratory values reflecting severe renal impairment.
Known history of moderately or severely impaired hepatic function.
History of or active hepatitis B or C within the past 3 months or history of HIV infection.
History of seizure disorder or epilepsy.
Any of the following within 1 year: mild/moderate traumatic brain injury, stroke, transient ischemic attack, or brain neoplasm. Severe traumatic brain injury within 15 years (consisting of 1 or more of the following: brain contusion, intracranial hematoma, either unconsciousness or post-traumatic amnesia lasting more than 24 h) or residual sequelae suggesting transient changes in consciousness.
Pregnant or breast-feeding.
History of allergy to, or hypersensitivity to tapentadol hydrochloride or its excipients, or contraindications related to tapentadol hydrochloride including:
Subjects with acute or severe bronchial asthma or hypercapnia.
Subjects who have or are suspected of having paralytic ileus.
Employees of the Investigator or trial site, with direct involvement in this trial or other trials under the direction of the Investigator or trial site, as well as family members of employees of the Investigator.
Participation in another trial concurrently or within 4 weeks prior to the Screening Visit.
Known to or suspected of not being able to comply with the protocol and the use of the IMPs.
Use of monoamine oxidase inhibitors within 14 days before the Screening Visit.
Non-stable dosing of selective serotonin reuptake inhibitors within 30 days before the Screening Visit (Doses must remain stable during the trial).
Key exclusion criteria (trial specific)
Osteoarthritis in a flare state.
Use of intra-articular injections of hyaluronic acid in the reference joint within 3 months before the Screening Visit.
Presence of conditions other than osteoarthritis of the reference joint that could confound the assessment or self-evaluation of pain, e.g., anatomical deformities, significant skin conditions such as abscess or syndromes with widespread pain such as fibromyalgia. Subjects with osteoarthritis at joints other than the reference joint will not be excluded as long as the reference joint is the source of main pain and disability.
History and clinical signs at the reference joint of crystal-induced (e.g., gout, pseudo-gout), metabolic, infectious and autoimmune disease.
Any concomitant painful condition that could interfere with the subjects? trial assessments or with their ability to differentiate the current joint pain from other painful conditions.
Any painful procedures during the t

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Dolor debido a Osteoartritis de rodilla
MedDRA version: 9.1 Level: LLT Classification code 10031165 Term: Osteoarthritis knee

Intervention(s)

Product Name: Tapentadol 50 mg film-coated tablet
Product Code: CG5503
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Tapentadol hydrochloride
CAS Number: 175591-09-0
Current Sponsor code: CG5503; R331333;
Other descriptive name: 3-[(1R,2R)-3-(dimethylamino)-1-ethyl-2-methylpropyl]phenol-hydrochloride
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-

Product Name: Tapentadol 50 mg prolonged release tablet
Product Code: CG5503
Pharmaceutical Form: Prolonged-release tablet
INN or Proposed INN: Tapentadol hydrochloride
CAS Number: 175591-09-0
Current Sponsor code: CG5503; R331333;
Other descriptive name: 3-[(1R,2R)-3-(dimethylamino)-1-ethyl-2-methylpropyl]phenol-hydrochloride
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-

Product Name: Tapentadol 100 mg prolonged release tablet
Product Code: CG5503
Pharmaceutical Form: Prolonged-release tablet
INN or Proposed INN: Tapentadol hydrochloride
CAS Number: 175591-09-0
Current Sponsor code: CG5503; R331333;
Other descriptive name: 3-[(1R,2R)-3-(dimethylamino)-1-ethyl-2-methylpropyl]phenol-hydrochloride
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-

Product Name: Tapentadol 150 mg prolonged release tablet
Product Code: CG5503
Pharmaceutical Form: Prolonged-release tablet
INN or Proposed INN: Tapentadol hydrochloride
CAS Number: 175591-09-0

Primary Outcome(s)

Main Objective: To evaluate the effectiveness, tolerability, and safety of tapentadol hydrochloride PR in subjects with chronic pain due to OA of the knee taking either WHO Step I or Step II analgesics or no regular analgesics and showing lack of efficacy

Secondary Objective: Demonstrate that tapentadol hydrochloride PR produces a better analgesia than previous Step I and Step II analgesics.
Evaluate the conversion of subjects from previous WHO Step II analgesics to tapentadol hydrochloride PR.
Evaluate the titration of tapentadol hydrochloride PR in clinical practice.
Evaluate whether the treatment with tapentadol hydrochloride PR can produce a reduction in the need for WHO Step I analgesics and co analgesics (sparing effect).
Evaluate whether the treatment with tapentadol hydrochloride PR can produce a reduction in the need for medications (antiemetics and laxatives) to treat opioid-related adverse events in subjects previously on WHO Step II opioid analgesics.
Evaluate the impact of tapentadol hydrochloride PR on function and quality of life parameters (subject-reported outcomes) in subjects with pain due to OA of the knee.

Primary end point(s): The primary endpoint is defined as the change from Week 1 of the average pain intensity score on an 11-point NRS-3 at Week 6

Secondary ID(s)

KF5503/42

2009-010423-58-GB

Ethics review

Status: Approved
Approval date:
Contact:

Results

• Results available: Yes
• Date Posted: 30/07/2015
• Date Completed: 02/09/2010
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2009-010423-58/results