The Purpose of This Study is to Determine if Tetrodotoxin (TTX) is Effective in the Treatment of Pain Resulting From Chemotherapy Treatment (TTX-CINP-201)
Tracking Information | |||||||||
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First Received Date ICMJE | July 19, 2012 | ||||||||
Last Updated Date | September 6, 2012 | ||||||||
Start Date ICMJE | July 2012 | ||||||||
Estimated Primary Completion Date | June 2015 (final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
Change from Baseline in patient reported outcome for pain at Day 22 to Day 28. [ Time Frame: Day 22 to Day 28 ] [ Designated as safety issue: No ] To identify up to two doses/regimens of Tetrodoxin (TTX) to bring forward to Part II for further evaluation. |
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | Complete list of historical versions of study NCT01655823 on ClinicalTrials.gov Archive Site | ||||||||
Current Secondary Outcome Measures ICMJE |
Safety [ Time Frame: screening to Day 28 ] [ Designated as safety issue: Yes ] To evaluate the number and severity of Adverse Events from subjects within each cohort against the other cohorts. |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
Current Other Outcome Measures ICMJE | |||||||||
Original Other Outcome Measures ICMJE | |||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | The Purpose of This Study is to Determine if Tetrodotoxin (TTX) is Effective in the Treatment of Pain Resulting From Chemotherapy Treatment | ||||||||
Official Title ICMJE | A Randomized, Double-Blind, Dose-Finding, Placebo Controlled, Phase II Multicenter Study of Tetrodotoxin in the Treatment of Chemotherapy Induced Neuropathic Pain | ||||||||
Brief Summary | Chemotherapy-induced peripheral neuropathy (CIPN) is a major dose-limiting side effect of many chemotherapeutic agents including vincristine, paclitaxel, cisplatin, oxaliplatin, bortezomib and ixabepilone. Chemotherapy-induced peripheral neuropathy commonly occurs in greater than 40% of patients. To improve the peripheral neuropathy, the chemotherapy dosing is often either decreased or discontinued potentially affecting tumor responsiveness, prognosis, and survival. There is an unmet medical need for treatment of cancer patients with chemotherapy induced neuropathic pain (CINP) and the proposed study will investigate the efficacy and safety of multiple dose levels of tetrodotoxin (TTX) versus placebo in moderate to severe neuropathic pain caused by chemotherapy. |
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Detailed Description | |||||||||
Study Type ICMJE | Interventional | ||||||||
Study Phase | Phase 2 | ||||||||
Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arm (s) |
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Publications * | |||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE | 275 | ||||||||
Estimated Completion Date | December 2015 | ||||||||
Estimated Primary Completion Date | June 2015 (final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||||||
Ages | 18 Years and older | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts ICMJE |
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Location Countries ICMJE | United States | ||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT01655823 | ||||||||
Other Study ID Numbers ICMJE | TTX-CINP-201 | ||||||||
Has Data Monitoring Committee | Yes | ||||||||
Responsible Party | Wex Pharmaceuticals Inc. | ||||||||
Study Sponsor ICMJE | Wex Pharmaceuticals Inc. | ||||||||
Collaborators ICMJE | |||||||||
Investigators ICMJE | |||||||||
Information Provided By | Wex Pharmaceuticals Inc. | ||||||||
Verification Date | September 2012 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |