Primary objectiveThe primary objective is to evaluate the effectiveness, safety, and tolerability of increasing doses of tapentadol PR (300 mg per day after run in, up titration to 500 mg per day) versus a combination of tapentadol PR (300 mg per…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
ernstig chronische lage rugpijn met een neuropatische component
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoint
Comparison of the average of 3 days pain intensity score (NRS 3) at the
Baseline Visit versus the average NRS 3 pain intensity score at the Final
Evaluation Visit of treatment arm 1 (increasing doses of tapentadol PR) and
treatment arm 2 (combination of tapentadol PR and pregabalin).
Secondary outcome
Secondary endpoints
Efficacy and quality of life endpoints
• Change of the pain intensity score on an 11 point NRS 3.
• PainDETECT score.
• NRS 3 pain intensity score for pain radiating towards or into the leg.
• Worst pain (11 point NRS) during the last 24 hours prior to the assessment
visit.
• Subject*s satisfaction with treatment (Verbal Rating Scale). Patient*s Global
Impression of Change.
• Clinician*s Global Impression of Change (CGIC).
• Neuropathic Pain Symptoms Inventory (NPSI).
• Sleep Evaluation Questionnaire (SQ) items.
• Hospital Anxiety and Depression Scale (HADS).
• Short Form 12® Health Survey (SF 12®) scores.
• EuroQol 5 Dimension (EQ 5D) scores.
Safety and tolerability endpoints
• Adverse events and adverse drug reactions.
• Vital signs.
• Clinical laboratory values.
• Medication used to treat the adverse events related to analgesic treatment.
Background summary
Chronic pain is a major health problem that affects a significant number of
subjects, resulting in personal suffering, reduced productivity, and
substantial health care costs. Low back pain is among the most common causes of
chronic pain. With lifetime prevalence rates of more than 70%, low back pain is
currently one of the major health problems of German adults. The estimated
prevalence of low back pain in the United States and Europe ranges from 7% to
39% according to different sources and it is considered the most common cause
of limited activity in adults younger than 45 years of age.
Both nociceptive and neuropathic components can contribute to low back pain.
Since these components require different pain management strategies, correct
pain diagnosis before and during treatment is highly desirable.
Chronic pain is a common symptom for many conditions. Pain is often experienced
as the most fear side effect. Pain has a direct impact on the quality of life,
productivity reduction and significant health costs.
tapentadol is a new analgesic that works on both the mu-receptors (inhibitory)
and on the re-uptake of noradrenaline. The effectiviness of tapentadol has been
demonstrated in phase II and III trials with indications of low back pain and
osteoarthritis of the knee. These studies has shown that tapentadol has a good
safety profile and a good gastrointestinal tolerance.
Study objective
Primary objective
The primary objective is to evaluate the effectiveness, safety, and
tolerability of increasing doses of tapentadol PR (300 mg per day after run in,
up titration to 500 mg per day) versus a combination of tapentadol PR (300 mg
per day after run in) and pregabalin (titrated to 300 mg per day) in subjects
requiring additional analgesia after titration to 300 mg per day of tapentadol
PR.
Secondary objectives
• To evaluate the impact of tapentadol PR or a combination of tapentadol PR and
pregabalin on function and quality of life parameters (subject reported
outcomes) in subjects with severe low back pain with a neuropathic pain
component.
• To evaluate a subset of subjects satisfied with moderate doses of tapentadol
PR (300 mg/day)
• To evaluate responder profiles based on painDETECT sub profiles.
Study design
Randomized, multicenter, multinational, double blind, active controlled,
parallel-arm, Phase IIIb trial with an open label run in period. The planned
number of subjects is 500.
Intervention
Intervention:
All patiënts will receive active study medication (tapentadol and/or
Pregabaline)
There are 4 phases during the trial:
Phase 1. Washout period of 3 to 14 days, in wich the patient's current
medication is to be down titrated under the supervision of the doctor in at
least 3 days.
Phase 2. Week 1 - week 3: titration of tapentadol. Titration of tapentadol to
300mg per day. Patient starts with 100 mg per day, the dosage will be increased
to 300 mg tapentadol per day depending on the pain intensity. But at the end of
the titration phase the dosage of the tapentadol have to be 300 mg per day.
Phase 3. From week 4, patients are randomly placed in one of two blinded
arms with IMP. The patient will be up titrated to max 500mg tapentadol per day,
or the patient receives a combination of tapentadol and Pregabalin, up titrated
to 300mg tapentadol + 300mg pregabalin. If the patients is under control after
the titration phase, he/she will stay in an open label arm with a fixed dose
tapentadol. IF the pateint suffers too many side effects, after randomisation,
he/she can enter the open label arm tapentadol with a maximum dosage tapentadol
of 400mg per day.
Phase 4. Week 14 and 15 end of trial, the study medication will be down
titrated.
Study burden and risks
The study will take 15 weeks. The patient wil visit the site at least 10 times,
for the other visits the patient will be contacted by telephone. During visit
-1 and 12 a blood and urine sample will be taken. Every sample contains 4-8 ml
blood. The maximum amount of blood collected during the study is around the
16ml per patient. The Heart frequency, blood pressure, length, wight and
physical examination shall be tested 2 times. In total, 8 different
questionnaires will be completed during most visits on site. Used
questionnaires: 11-point NRS-3 and NRS-24 painscale, NPSI, EuroQol-5,
satisfaction questionnaire, SF-12, Sleep questionnair, HADS, PGIC/CGIC,
painDETECT. Al questionnaires need to be completed by the patient on site on a
"palmtop".
Kosterijland 70-78
3981 AJ Bunnik
NL
Kosterijland 70-78
3981 AJ Bunnik
NL
Listed location countries
Age
Inclusion criteria
Signed Informed consent. Male of female older then 18 years with severe chronic low back pain with a neuropathic component, for at least 3 months. Using a step II of III analgetic for at least 2 weeks before enrollment. When treatment with step II analgetics the pain must be 5 or higher for the last 3 days before enrollment. When using a step I analgetic a pain of 6 or higher must be scored.Woman of childbearing potential must be using birthcontrol, must have a negative pregnancy test and no breastfeeding allowed.
Exclusion criteria
alcohol or drug abuse, presence of systemic or local infections, hypersensitivity of tapentadol, participation in another trial, use of MAO inhibitors within 14 days before enrollment, non-stable dosing SSRI's. Presence of clinically significant disease of laboratory findings that according to the investigator effect safety and efficacy.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2010-019998-14-NL |
| CCMO | NL33802.060.10 |