Tapentadol Prolonged Release (PR) Versus Oxycodone/Naloxone Prolonged Release in Severe Chronic Low Back Pain With a Neuropathic Component.
Information source: Grünenthal GmbH
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Back Pain; Low Back Pain; Neuropathic Pain
Intervention: Tapentadol Prolonged Release (Drug); Oxycodone/Naloxone Prolonged Release (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Grünenthal GmbH Official(s) and/or principal investigator(s): Director Clinical Trials, Study Director, Affiliation: Grünenthal GmbH
Summary
This was a clinical effectiveness trial designed to compare the effectiveness, safety, and
tolerability of treatment with tapentadol prolonged release with that of oxycodone/naloxone
prolonged release in non-opioid pre-treated subjects with severe chronic low back pain with
a neuropathic pain component.
Both tapentadol and the opioid oxycodone are effective in chronic severe pain and tapentadol
and oxycodone/naloxone have shown advantages in gastrointestinal tolerability versus
oxycodone. Therefore, it was of high scientific interest to compare the latter 2 analgesics
with respect to gastrointestinal tolerability. Tapentadol may have advantages regarding the
neuropathic pain-related symptoms of low back pain due to its 2 mechanisms of action.
Clinical Details
Official title: Evaluation of the Effectiveness, Safety, and Tolerability of Tapentadol PR Versus Oxycodone/Naloxone PR in Non-opioid Pre-treated Subjects With Uncontrolled Severe Chronic Low Back Pain With a Neuropathic Pain Component.
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Change in the Average Pain Intensity Score on an 11-point Numeric Rating Scale (NRS-3)Change in the Patient Assessment of Constipation Symptoms (PAC-SYM) Total Score
Secondary outcome: Recalled Average Pain IntensityChange in Recalled Average Pain Intensity at the End of Treatment Average Pain Intensity Over Three Days for Pain Radiating Towards or Into the Leg Change of Average Pain Intensity Over Three Days for Pain Radiating Towards or Into the Leg at the End of Treatment Worst Pain Intensity Over the Past 24 Hours Change in Worst Pain Intensity Over the Past 24 Hours at the End of Treatment painDETECT Final Assessment Change in painDETECT Final Assessment at the End of Treatment Neuropathic Pain Symptom Inventory (NPSI) Sub-scores and Overall Score Assessment Change in Neuropathic Pain Symptom Inventory (NPSI) Sub-scores and Overall Score Assessment at the End of Treatment Short Form Health Survey (SF-12) Changes in the Short Form Health Survey (SF-12) at the End of Treatment EuroQol-5 (EQ-5D) Health Status Index Outcome Change in EuroQol-5 (EQ-5D) Health Status Index Outcome at the End of Treatment Hospital Anxiety and Depression Scale: Anxiety Change in Hospital Anxiety and Depression Scale at the End of Treatment: Anxiety Hospital Anxiety and Depression Scale: Depression Change in Hospital Anxiety and Depression Scale at the End of Treatment: Depression Patient Global Impression of Change at the End of Treatment Clinician Global Impression of Change at the End of Treatment Sleep Evaluation at the End of Treatment: Change in the Overall Quality of Sleep Sleep Evaluation: Number of Awakenings Sleep Evaluation at the End of Treatment: Change in the Number of Awakenings Sleep Evaluation: Number of Hours Slept Sleep Evaluation at the End of Treatment: Change in the Number of Hours Slept Sleep Evaluation: Latency (Time Taken to Fall Asleep) Sleep Evaluation at the End of Treatment: Change in Latency (Change in the Time Taken to Fall Asleep) Comparison of the Number of Participants Affected by Gastrointestinal Treatment Emergent Adverse Events (TEAEs) Typical for Opioids Composite Event Based Comparison of Gastrointestinal Treatment Emergent Adverse Events (TEAEs) Typical for Opioids
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Informed consent signed.
- Male or female 18 years of age or older.
- Women of childbearing potential must have a negative pregnancy test at the Enrollment
Visit.
- Women of childbearing potential must practice medically acceptable methods of birth
control during the trial.
- Participant must be appropriately communicative and able to differentiate with regard
to location and intensity of the pain, and to complete the questionnaires used in
this trial.
- Participants must have a diagnosis of chronic low back pain; chronic pain defined as
pain lasting for at least 3 months prior to enrollment.
- Participant's pain must require a strong analgesic (defined as World Health
Organization Step III) as judged by the investigator.
- Participants who require a washout of co-analgesics at enrolment must have an average
pain score (NRS-3) of 5 points or higher. Participants who do not require a washout
of co-analgesics at enrollment must have an average pain intensity score (NRS-3)
during the last 3 days of 6 points or higher.
- The painDETECT diagnostic screening questionnaire must be either "positive" (score of
19 to 38 inclusive) or "unclear" (score of 13 to 18 inclusive). If the participant is
being treated with a stable regimen of centrally acting co-analgesics, a "negative"
painDETECT score (score 9 points or higher).
Inclusion criteria prior to allocation to treatment:
- Participants must have an average pain intensity score (NRS-3) during the last 3 days
of 6 points or higher.
- Participants must score either "positive" (score of 19 to 38 inclusive) or "unclear"
(score of 13 to 18 inclusive) on the painDETECT diagnostic screening questionnaire.
Exclusion Criteria:
- Presence of a clinically significant disease or clinical laboratory values that in
the investigator's opinion may affect effectiveness, quality of life, or
safety/tolerability assessments.
- Presence of active systemic or local infections that may, in the opinion of the
investigator, affect the effectiveness, quality of life, or safety/tolerability
assessments.
- 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
Enrollment Visit.
- Known to or suspected of not being able to comply with the protocol and/or
appropriate use of the Investigational Medicinal Products.
- Any painful procedures (e. g., major surgery) scheduled during the trial duration
(Enrollment Visit until Final Evaluation Visit) that may, in the opinion of the
investigator, affect the effectiveness, quality of life, or safety assessments.
- Pending litigation or application for insurance/governmental benefits due to chronic
pain or disability and/or if the granted benefits might be influenced by a successful
participation in the trial.
- Low back pain caused by cancer and/or metastatic diseases.
- History of alcohol or drug abuse, or suspicion thereof in the investigator's
judgment.
- Presence of concomitant autoimmune inflammatory conditions.
- Participants with acute intoxication with alcohol, hypnotics, centrally acting
analgesics, or psychotropic active substances.
- Participants with severe renal impairment, i. e., estimated glomerular filtration rate
less than 30 mL/min (according to the National Kidney Foundation 2002).
- Known history of clinical laboratory values or current clinical laboratory values
reflecting moderately or severely impaired hepatic function.
- 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 (including brain metastases if present
at the Enrollment Visit). 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 hours) or residual
sequelae suggesting transient changes in consciousness.
- Pregnant or breast-feeding women.
- Severe respiratory depression with hypoxia and/or hypercapnia, acute or severe
bronchial asthma or severe chronic obstructive pulmonary disease.
- Presence or suspicion of paralytic ileus.
- Participants with severe cardiac impairment, e. g., New York Heart Association class
>3, myocardial infarction less than 6 months prior to the Enrollment Visit, and/or
unstable angina pectoris and/or cor pulmonale.
- Participant with known history of rare hereditary problems of galactose intolerance,
the Lapp lactase deficiency, or glucose-galactose malabsorption.
- History of allergy or hypersensitivity to tapentadol, oxycodone, naloxone, and their
formulations.
- Participants with acute biliary obstruction or acute pancreatitis.
- Participants with hypothyroidism (including myxedema) or Addison's disease.
- Participants taking any prohibited concomitant medication.
Locations and Contacts
AT001, Senftenberg 3541, Austria
AT002, Vienna 1100, Austria
DE005, Bad Saarow 15526, Germany
DE007, Berlin 10435, Germany
DE009, Berlin 12627, Germany
DE021, Berlin 10787, Germany
DE030, Berlin 13125, Germany
DE020, Bochum 44787, Germany
DE023, Böhlen 04564, Germany
DE028, Cottbus 03050, Germany
DE012, Dresden 01067, Germany
DE032, Essen 45355, Germany
DE003, Frankfurt 60596, Germany
DE017, Frankfurt 60313, Germany
DE011, Görlitz 02826, Germany
DE031, Hamburg 20253, Germany
DE013, Hannover 30159, Germany
DE001, Kiel 24105, Germany
DE014, Kiel 24119, Germany
DE027, Kiel 24106, Germany
DE008, Köln 51069, Germany
DE029, Köln 50924, Germany
DE004, Leipzig 04103, Germany
DE018, Leipzig 04109, Germany
DE034, Leipzig 04107, Germany
DE015, Magdeburg 39104, Germany
DE006, Mainz 55116, Germany
DE002, Mittweida 09648, Germany
DE010, Rudolstadt 07407, Germany
DE025, Schwerin 19055, Germany
DE019, Stadtroda 07646, Germany
DE016, Weinheim 69469, Germany
DE024, Westerstede 26655, Germany
DE022, Wiesbaden 65187, Germany
DE026, Wiesbaden 65185, Germany
IT003, Catania 95125, Italy
IT001, Genova 16132, Italy
IT002, Parma 43126, Italy
IT004, Pavia 27100, Italy
IT005, Varese 21046, Italy
ES006, A Coruna 15006, Spain
ES001, Barcelona 08916, Spain
ES007, Barcelona 08006, Spain
ES003, Centelles 08540, Spain
ES008, Guadix 18500, Spain
ES002, Madrid 28046, Spain
ES009, Madrid 28850, Spain
ES010, Madrid 28050, Spain
ES004, Oviedo 33009, Spain
ES005, Santiago de Compostela 15705, Spain
Additional Information
Starting date: April 2013
Last updated: May 22, 2015
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