An evaluation of the effectiveness and tolerability of tapentadol hydrochloride prolonged release, and tapentadol hydrochloride immediate release on demand, in subjects with uncontrolled severe chronic nociceptive, mixed or neuropathic low back pain taking either WHO Step I or Step II analgesics or no regular analgesics - ND

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2009-010427-12-IT
• Date of registration: 25/06/2009
• Prospective Registration: Yes
• Primary sponsor: Grünenthal GmbH
• Public title: An evaluation of the effectiveness and tolerability of tapentadol hydrochloride prolonged release, and tapentadol hydrochloride immediate release on demand, in subjects with uncontrolled severe chronic nociceptive, mixed or neuropathic low back pain taking either WHO Step I or Step II analgesics or no regular analgesics - ND
• Scientific title: An evaluation of the effectiveness and tolerability of tapentadol hydrochloride prolonged release, and tapentadol hydrochloride immediate release on demand, in subjects with uncontrolled severe chronic nociceptive, mixed or neuropathic low back pain taking either WHO Step I or Step II analgesics or no regular analgesics - ND
• Date of first enrolment: 20/07/2009
• Target sample size: 180
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-010427-12
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: no Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: Placebo: Other:

Countries of recruitment

Austria, France, Germany, Italy, Poland, 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) Subjects must be at least 18 years of age. Subjects must have a diagnosis of chronic low back pain; chronic pain defined as pain lasting for at least 3 months If the subject has radicular pain, this must have been present for at least 3 months and stable for the 4 weeks before enrollment. 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 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 low back pain.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. History of alcohol or drug abuse, or suspicion of in Investigator?s judgement. 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. 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 (the doses must remain stable during the trial). Key exclusion criteria (trial specific) Presence of conditions other than low back pain 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. Any concomitant painful condition that could interfere with the subject?s trial assessments or with their ability to differentiate low back pain from other painful conditions. Any painful procedures during the trial (e.g., major surgery) that may, in the opinion of the Investigator, affect the efficacy or safety assessments. Pending litigation due to chronic pain or disability. Intake of Step III analgesics within the 30 days prior to the Screening Visit.


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

Health Condition(s) or Problem(s) studied

low back pain
MedDRA version: 12.0 Level: LLT Classification code 10024891 Term: Low back pain

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
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
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
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
Current Sponsor code: CG5503, R331333
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-

Product Name: Tapentadol 200 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
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-

Product Name: Tapentadol 250 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
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 250-

Primary Outcome(s)

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 medications (antiemetics and laxatives) to treat opioid-related adverse events in subjects previously treated with WHO Step II opioid analgesics.Evaluate the efficacy of tapentadol hydrochloride PR versus previous treatment in low back pain due to mixed and neuropathic origin. Evaluate the efficacy of tapentadol hydrochloride PR versus previous treatment in low back pain due to mixed and neuropathic origin. Evaluate the efficacy of tapentadol hydrochloride PR in subjects with neuropathic or mixed versus nociceptive low back pain. Evaluate the impact of tapentadol hydrochloride PR on

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

Main Objective: To evaluate the effectiveness, tolerability, and safety of tapentadol hydrochloride PR in subjects with severe chronic nociceptive, mixed or neuropathic low back pain showing lack of efficacy under previous WHO Step I and Step II treatment or no regular analgesics

Secondary ID(s)

2009-010427-12-GB

KF5503/44