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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 Intensity

Change 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

Page last updated: August 23, 2015

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