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A Study to Evaluate Tapentadol (CG5503) in the Treatment of Chronic Tumor-Related Pain Compared With Placebo and Morphine

Information source: Grünenthal GmbH
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Tumor; Pain

Intervention: Tapentadol Extended Release (Drug); Matching Placebo after Tapentadol in the Titration Phase. (Drug); Morphine Sulphate Controlled Release (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Grünenthal GmbH

Official(s) and/or principal investigator(s):
Hans Georg Kress, Dr., Principal Investigator, Affiliation: Clinic of Anaesthesiology and Pain Management, AKH Vienna

Summary

The purpose of this study will be to determine whether tapentadol (CG5503) is effective and safe in the treatment of chronic tumor related pain compared to placebo. In addition tapentadol (CG5503) will also be compared to morphine controlled release, also referred to as slow release (SR). *Tapentadol prolonged-release (PR) is the term used in the European Union and is referred to as extended release (ER) in the United States.

Clinical Details

Official title: A Randomized Withdrawal, Active- and Placebo-controlled, Double-blind, Multi-center Phase III Trial Assessing Safety and Efficacy of Oral CG5503 (Tapentadol) PR* in Subjects With Moderate to Severe Chronic Malignant Tumor-related Pain

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Number of Participants Scored as Responder in Maintenance Phase.

Secondary outcome:

Average Daily Pain Intensity Scores, Averaged Per Week by Treatment, During the Titration Phase in the Tapentadol Treatment Arm.

Average Daily Pain Intensity Scores, Averaged Per Week by Treatment, During the Titration Phase in the Morphine Treatment Arm.

Average Daily Pain Intensity Scores, Averaged Per Week by Treatment, During the Maintenance Phase.

Current Pain Intensity Scores, Averaged Per Week, During the Titration Phase in the Tapentadol Arm.

Current Pain Intensity Scores, Averaged Per Week, During the Titration Phase in the Morphine Arm.

Current Pain Intensity Scores, Averaged Per Week by Treatment, During the Maintenance Phase.

Use of Rescue Medication in the Titration Phase.

Number of Participants Using Immediate Release Morphine Rescue Medication in the Maintenance Phase

The Average Mean Total Daily Dose of Rescue Medication.

Changes in the Short Form 36® Health Survey (SF-36®) During the Titration Phase.

Changes in the Short Form 36® Health Survey (SF-36®) During the Maintenance Phase.

Change in the EuroQoL (EQ-5D) Health Status Index (United Kingdom Time Trade-off Value Set) Change From Start of Titration to Endpoint Titration.

Health Related Quality of Life: EuroQol-5D Health State Visual Analog Scale (VAS) Titration Phase.

Change in the EuroQoL (EQ-5D) Health Status Index (United Kingdom Time Trade-off Value Set) Over Time in the Maintenance Phase for Tapentadol and the Placebo Randomized Withdrawal Treatment Arms.

Changes in Health Related Quality of Life: EuroQol-5D Health State Visual Analog Scale (VAS) Maintenance Phase.

Patient Global Impression of Change

Quality of Sleep (Sleep Questionnaire) in the Titration Phase.

Quality of Sleep (Sleep Questionnaire) During the Maintenance Phase of the Trial.

Clinical Opioid Withdrawal Scale (COWS) at the End of the Titration Phase.

Clinical Opioid Withdrawal Score (COWS) at the End of the Maintenance Phase.

Change in the Patient Assessment of Constipation Symptoms (PAC-SYM) During the Titration Phase

Change in the Patient Assessment of Constipation Symptoms (PAC-SYM) During the Maintenance Phase

Detailed description: Normally chronic tumor related pain is controlled when participants receive repeated doses of opioid analgesics. However, opioid therapy is commonly associated with side effects such as nausea, vomiting, sedation, constipation, addiction, tolerance, and respiratory depression. Tapentadol (CG5503), a newly synthesized drug with an prolonged release (PR) formulation, also acts as a centrally acting pain reliever but has 2 mechanisms of action. The aim of this trial is to investigate the effectiveness (level of pain control) and safety (side effects) of tapentadol (CG5503) PR compared with no drug (placebo) and corresponding dose of morphine (an opioid commonly used to treat tumor related pain). This trial is a randomized, double-blind (neither investigator nor patient will know which treatment was received), active- and placebo-controlled, parallel-group, randomized withdrawal design, multicenter trial. The trial includes a 2 week titration phase starting with either 40 mg morphine (PR) bid (bid = twice daily dosing, one dose in the morning and one dose in the evening) or 100 mg tapentadol (CG5503) PR bid. Based on effectiveness and side effects subjects can up-titrate in steps of 50 mg tapentadol (CG5503 PR) to a maximal dose of 250 mg tapentadol (CG5503) PR bid or 100 mg morphine PR bid. If participants meet the stabilisation criteria at the end of the titration phase they will be re-randomized to either placebo or active treatment and will continue 4 weeks at the last dose level in the maintenance phase. Only participants on tapentadol in the titration phase will be re-randomized to either matching placebo or to tapentadol. To maintain the blinding nature of the trial participants in the morphine arm during the titration phase will also be re-randomized however they will all remain on morphine controlled release in the maintenance phase. Placebo to match tapentadol tablets, as well as placebo to match morphine capsules, will be used to mask the treatment allocation. Participants will be issued with an electronic diary (eDiary) to capture Numeric Rating Scale (NRS) pain intensities. Assessments of pain relief include the pain intensity numeric rating scale (NRS) and patient global impression of change (PGIC). Safety evaluations include monitoring of adverse events, physical examinations, clinical laboratory tests and electrocardiograms. Venous blood samples will be collected for the determination of serum concentrations of tapentadol (CG5503).

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria

- Male and non-pregnant, non-lactating female subjects.

- Of at least 18 years of age with chronic malignant tumor-related pain with a mean

pain intensity (NRS) of 5 points or higher.

- Subjects who are opioid-naĂŻve or pretreated with an equianalgesic dose range

equivalent of up to 160 mg oral morphine per day and are dissatisfied with prior treatment.

- Women must be postmenopausal, surgically sterile, or practicing or agree to practice

an effective method of birth control throughout the trial.

- Expected course of the disease and the pain that would permit compliance with the

trial protocol over the entire trial period. Exclusion Criteria Key Exclusion Criteria:

- Subjects will be excluded from the study if they have a history of seizure disorder

or epilepsy;

- known history and/or presence of cerebral tumor or cerebral metastases.

- history of alcohol or drug abuse;

- uncontrolled hypertension,

- clinical laboratory values reflecting severe renal insufficiency,

- moderate or severe hepatic impairment,

- hepatitis B or C, HIV,

- inadequate bone marrow reserve

- currently treated with radiotherapy,

- pain-inducing chemotherapy,

- anti-parkinsonian drugs, neuroleptics, monoamine oxidase inhibitors, serotonin

norepinephrine reuptake inhibitor (SNRI) or any other analgesic therapy than investigational medication or rescue medication during the trial.

- selective serotonin reuptake inhibitor (SSRI) treatments are allowed if taken for at

least 30 days before the screening period of the study at an unchanged dose.

Locations and Contacts

Site 043004, Klagenfurt 9020, Austria

Site 043001, Vienna 1090, Austria

Site 043002, Vienna 1020, Austria

Site 043005, Vienna 1100, Austria

Site 359013, Gabrovo 5300, Bulgaria

Site 359011, Pleven 5800, Bulgaria

Site 359014, Plovdiv 4004, Bulgaria

Site 359004, Shoumen 9700, Bulgaria

Site 359008, Sofia 1784, Bulgaria

Site 359012, Varna 9003, Bulgaria

Site 385007, Osijek 31000, Croatia

Site 385001, Slavonski Brod 35000, Croatia

Site 385004, Varazdin 42000, Croatia

Site 385006, Zabok 49210, Croatia

Site 385002, Zagreb 10000, Croatia

Site 385003, Zagreb 10000, Croatia

Site 420005, Brno 62500, Czech Republic

Site 420002, Ceske Budejovice 37087, Czech Republic

Site 420006, Hradec Kralove 50005, Czech Republic

Site 420007, Liberec 46063, Czech Republic

Site 420008, Olomouc 77520, Czech Republic

Site 420001, Pilsen 30460, Czech Republic

Site 420004, Prague 18181, Czech Republic

Site 033101, Tarbes 65000, France

Site 049009, Berlin 12627, Germany

Site 049014, Essen 45122, Germany

Site 049012, Köln 50996, Germany

Site 049007, Loewenstein 74245, Germany

Site 049020, Potsdam 14467, Germany

Site 049006, Waldkirch 79183, Germany

Site 049002, Wiesbaden 65185, Germany

Site 036001, Debrecen 4043, Hungary

Site 036005, Komárom 2900, Hungary

Site 036003, Mátraháza 3233, Hungary

Site 036002, Nyiregyhaza 4412, Hungary

Site 036010, Szekszard 7100, Hungary

Site 036006, Székesfehérvár 8000, Hungary

Site 036009, Székesfehérvár 8000, Hungary

Site 039001, Napoli 80131, Italy

Site 373001, Chisinau 2025, Moldova, Republic of

Site 373002, Chisinau 2025, Moldova, Republic of

Site 048004, Bydgoszcz 85796, Poland

Site 048005, Gdanks 80286, Poland

Site 048007, Poznan 60355, Poland

Site 048001, Warszawa 02781, Poland

Site 040006, Brasov 500074, Romania

Site 040002, Bucharest 022328, Romania

Site 040003, Bucharest 022328, Romania

Site 040004, Bucharest 022328, Romania

Site 040005, Cluj-Napoca 400015, Romania

Site 040001, Iasi 700106, Romania

Site 040007, Timisoara 300239, Romania

Site 007010, Arkhangels 163045, Russian Federation

Site 007003, Moscow 125284, Russian Federation

Site 007007, Nizhniy Novgorod 603140, Russian Federation

Site 007012, Vladikavkaz 362007, Russian Federation

Site 007005, Yaroslavl 150054, Russian Federation

Site 381003, Belgrade 11000, Serbia

Site 381004, Belgrade 11000, Serbia

Site 381005, Belgrade 11000, Serbia

Site 381002, Nis 18000, Serbia

Site 381001, Sremska Kamenica 21204, Serbia

Site 421005, Banska Bystrica 97517, Slovakia

Site 421001, Kosice 04191, Slovakia

Site 034005, Barcelona 08221, Spain

Site 034009, Barcelona 08208, Spain

Site 034006, Mahon Menorca 07703, Spain

Site 034012, Pamplona 31008, Spain

Site 034004, Sevilla 1013, Spain

Site 034002, Valencia 46014, Spain

Site 046001, Stockholm 17176, Sweden

Additional Information

Starting date: July 2007
Last updated: March 24, 2015

Page last updated: August 23, 2015

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