Method of Pre-treatment for Application of QUTENZA Capsaicin 8% Patch (LIFT)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT01416116 |
|
Recruitment Status :
Completed
First Posted : August 12, 2011
Last Update Posted : April 23, 2018
|
Sponsor:
Astellas Pharma Inc
Information provided by (Responsible Party):
Astellas Pharma Inc
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Brief Summary:
The Summary of product characteristics (SmPC) for QUTENZA advises that topical anaesthetic is applied prior to the application of QUTENZA. This is a multi-center, randomized, assessor-blinded study which will investigate the use of an oral analgesic as an alternative form of pre-treatment for QUTENZA.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| or Peripheral Nerve Injury (PNI) Peripheral Neuropathic Pain (PNP) Due to Postherpetic Neuralgia (PHN) | Drug: QUTENZA Drug: Lidocaine Drug: Tramadol | Phase 4 |
All patients will be treated with QUTENZA for 60 minutes. Patients will be randomized to one of two arms- application of topical anaesthetic (lidocaine cream) or an oral analgesic (tramadol oral tables) prior to application of QUTENZA. Patients will be followed up for 7 days to monitor pain scores and tolerability.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 122 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Tolerability of QUTENZATM When Applied After Pre-treatment With Lidocaine or Tramadol in Subjects With Peripheral Neuropathic Pain - A Randomized, Multi-center, Assessor-blinded Study |
| Actual Study Start Date : | July 6, 2011 |
| Actual Primary Completion Date : | April 25, 2012 |
| Actual Study Completion Date : | April 25, 2012 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Tramadol
Tramadol prior to QUTENZA
|
Drug: QUTENZA
topical
Other Name: capsaicin 8% patch Drug: Tramadol oral |
|
Experimental: Lidocaine
Lidocaine prior to QUTENZA
|
Drug: QUTENZA
topical
Other Name: capsaicin 8% patch Drug: Lidocaine topical |
Primary Outcome Measures :
- The proportion of subjects who tolerate QUTENZA treatment [ Time Frame: 60 minute application period ]A QUTENZA tolerant subject is defined as a subject receiving at least 90% of the intended patch duration.
Secondary Outcome Measures :
- Duration of patch application [ Time Frame: 60 minutes ]
- Change in pain scores from baseline to subsequent timepoints on the day of patch application [ Time Frame: 5, 25, 55, 85, 115 minutes on day of application and once a day on days 1, 2, 3 ]
- Proportion of subjects using pain medications and dose of pain medication(s) administered [ Time Frame: day 1-5 ]
- Subject rated tolerability score [ Time Frame: Baseline to end of study visit, day 7 ]
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 90 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Diagnosis of postherpetic neuralgia or neuropathic pain due to peripheral nerve injury
- Daily pain score ≥ 4 for average pain both at the Screening Visit and at the Treatment Visit
- Intact, non-irritated, dry skin over the painful area(s) to be treated
Exclusion Criteria:
- Significant ongoing or recurrent pain other than due to PHN or peripheral nerve injury
- Past or current history of Type I or Type II diabetes mellitus
- Active malignancy or treatment for malignancy within a year prior to the Treatment Visit
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01416116
Locations
Show 20 study locations
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
| Study Director: | Senior Study Manager, Late Phase Clinical Development & Operations | Astellas Pharma Europe Limited |
Additional Information:
| Responsible Party: | Astellas Pharma Inc |
| ClinicalTrials.gov Identifier: | NCT01416116 |
| Other Study ID Numbers: |
QTZ-EC-0002 2010-023258-34 ( EudraCT Number ) |
| First Posted: | August 12, 2011 Key Record Dates |
| Last Update Posted: | April 23, 2018 |
| Last Verified: | April 2018 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
Keywords provided by Astellas Pharma Inc:
|
Tramadol QUTENZA Pre-treatment Tolerability |
Additional relevant MeSH terms:
|
Neuralgia Neuralgia, Postherpetic Peripheral Nerve Injuries Peripheral Nervous System Diseases Neuromuscular Diseases Nervous System Diseases Pain Neurologic Manifestations Trauma, Nervous System Wounds and Injuries Lidocaine Tramadol Capsaicin Anesthetics, Local Anesthetics |
Central Nervous System Depressants Physiological Effects of Drugs Sensory System Agents Peripheral Nervous System Agents Anti-Arrhythmia Agents Voltage-Gated Sodium Channel Blockers Sodium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Analgesics, Opioid Narcotics Analgesics Antipruritics Dermatologic Agents |