Tapentadol in Chronic Malignant Tumour Related
This study is currently recruiting participants.
Verified December 2012 by Grünenthal GmbH
Sponsor:
Grünenthal GmbH
Information provided by (Responsible Party):
Grünenthal GmbH
ClinicalTrials.gov Identifier:
NCT01264887
First received: December 16, 2010
Last updated: December 21, 2012
Last verified: December 2012
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Purpose
The purpose of this trial is the characterization of the long term safety profile and long-term dose requirements of tapentadol ER in patients with malignant tumor-related pain.
| Condition | Intervention | Phase |
|---|---|---|
|
Cancer Chronic Pain Pain Tumour Related Pain |
Drug: tapentadol prolonged release (extended release - depending on the region of the world) |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Open-label, Single-arm, Flexible Dosing, Phase III Trial, With Oral Tapentadol PR in Subjects With Chronic Malignant Tumor-related Pain Who Have Completed the Maintenance Period of the KF5503/15 Trial. |
Resource links provided by NLM:
Further study details as provided by Grünenthal GmbH:
Primary Outcome Measures:
- Number of subjects with Adverse Events as a measure of safety and tolerability [ Time Frame: From date of first IMP intake until date of 3 days after last IMP intake, assessed up to 4 years ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Assess consumption of tapentadol during long term use [ Time Frame: From date of first IMP intake until date of last IMP intake, assessed up to 4 years ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 90 |
| Study Start Date: | December 2010 |
| Estimated Study Completion Date: | April 2015 |
| Estimated Primary Completion Date: | February 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Tapentadol Prolonged Release (Extended Release)
Participants allocated to this treatment arm can be dosed between 100 to 250 mg tapentadol twice daily
|
Drug: tapentadol prolonged release (extended release - depending on the region of the world)
Titration to achieve sufficient pain relief to continue with effective analgesia for as long as the participant tolerates and wishes to continue treatment.
|
Detailed Description:
The prevalence of tumor-related pain is high and the treatment of chronic tumor-related pain remains a challenging therapeutic problem.
This is a clinical trial with only 1 treatment group: tapentadol ER 100 mg to 250 mg twice daily.
For subjects who have directly entered the KF5503/52 trial from the KF5503/15 trial (i.e., within 7 days of Visit 8 of the KF5503/15 trial): a Transfer Visit, an Open-label Treatment Period and a Follow-up Period.
For subjects who have a gap of more than 7 days and less than 24 weeks, between their full completion of the KF5503/15 trial and entry into the KF5503/52 trial: an Enrollment Visit, an Entry Visit for assessment of eligibility, an Open-label Treatment Period and a Follow-up Period.
This trial was designed to offer patients with chronic malignant tumor-related pain the option of continuing treatment by receiving tapentadol PR.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Subjects must have signed an Informed Consent Form.
- At least 18 years of age.
- Male and non-pregnant, non-lactating female subjects. Sexually active women must be post menopausal, surgically sterile, or practicing an effective method of birth control before entry and throughout the trial. Female subjects of child-bearing potential must have a negative pregnancy test at enrollment.
- Within 24 weeks of either full completion or completion of the Double-blind Treatment Period (Visit 8) of KF5503/15 trial performed in subjects with moderate to severe chronic malignant tumor related pain.
- Subject is, in the opinion of the Investigator, expected to continue to have an overall positive benefit/risk ratio from continuing analgesic treatment within this trial.
- Subjects must be willing to take tapentadol PR throughout their participation in the trial.
Exclusion Criteria:
- History of alcohol and/or drug abuse.
- The subject has a clinically significant disease other than cancer that in the Investigator's opinion may affect the safety of the subject.
- Employees of the Investigator or trial center or family members of the employees or the Investigator.
- Known to or suspected of not being able to comply with the protocol and the use of tapentadol PR.
- Concurrent participation in another trial (except for participation in the KF5503/15 trial) or planning to be enrolled in another clinical trial during the course of this trial.
- Previous participation in another trial between the end of KF5503/15 and enrollment into the current trial, KF5503/52.
- History of seizure disorder, epilepsy, traumatic brain injury, stroke or transient ischemic attack.
- Known history and/or presence of cerebral tumors or metastases.
- Rapidly escalating pain or pain uncontrolled by therapy and was previously treated with maximum (dose level 4) Investigational Medicinal Product dose.
- Subjects taking any prohibited concomitant medications.
- Uncontrolled hypertension.
- Known moderate or severe hepatic impairment.
- Known severe renal impairment.
- Clinically relevant history of hypersensitivity, allergy, or contraindications to mu-opioid receptor agonists.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01264887
Show 33 Study Locations
Contacts
| Contact: René Allard | +49 241 569 3223 | Clinical-Trials@grunenthal.com |
Show 33 Study LocationsSponsors and Collaborators
Grünenthal GmbH
Investigators
| Principal Investigator: | Hans-Georg Kress, Prof. Dr. med | General Hospital Vienna |
More Information
No publications provided
| Responsible Party: | Grünenthal GmbH |
| ClinicalTrials.gov Identifier: | NCT01264887 History of Changes |
| Other Study ID Numbers: | 168935, 2009-013291-46 |
| Study First Received: | December 16, 2010 |
| Last Updated: | December 21, 2012 |
| Health Authority: | Austria: Agency for Health and Food Safety Bulgaria: Bulgarian Drug Agency Croatia: Ministry of Health and Social Care Czech Republic: State Institute for Drug Control France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Germany: Federal Institute for Drugs and Medical Devices Hungary: National Institute of Pharmacy Poland: The Central Register of Clinical Trials Romania: National Medicines Agency Russia: The Ministry of Health and Social Development of the Russian Federation Serbia: Agency for Drugs and Medicinal Devices Spain: Agencia Espanola de Medicamentos y Productos Sanitarios |
Keywords provided by Grünenthal GmbH:
|
analgesia analgesics cancer |
chronic pain pain tumour related pain |
Additional relevant MeSH terms:
|
Neoplasms |
ClinicalTrials.gov processed this record on May 16, 2013