Clinical TrialID 7629
A Randomized, Double-Blind, Placebo Controlled, Multicenter, Efficacy and Safety Trial of Single Cycle Tetrodotoxin in the Treatment of Chemotherapy Induced Neuropathic Pain
NCT05359133
Chemotherapy-induced Neuropathic Pain|Chemotherapy-induced Peripheral Neuropathy
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Record Fields
Scalar fields from the final clinical_trial record.
- Clinical Trial Id
- 7629
- Evidence Id
- 7629
- Core Evidence Id
- 7629
- Source Clinical Trial Id
- 7626
- Herb2 Clinical Trial Id
- HBCT007626
- Nct Id
- NCT05359133
- Title
- A Randomized, Double-Blind, Placebo Controlled, Multicenter, Efficacy and Safety Trial of Single Cycle Tetrodotoxin in the Treatment of Chemotherapy Induced Neuropathic Pain
- Status
- Recruiting
- Phase
- Phase 2
- Study Result
- No
- Study Condition
- Chemotherapy-induced Neuropathic Pain|Chemotherapy-induced Peripheral Neuropathy
- Study Type
- Interventional
- Study Design
- Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
- Intervention
- DRUG: Tetrodotoxin|DRUG: Placebo
- Intervention Allocation
- Randomized
- Intervention Model
- Parallel
- Intervention Mask
- Quadruple
- Intervention Purpose
- Treatment
- Gender
- All
- Age
- Adult, Older_Adult
- Enrollment
- 222
- Outcome Measure
- NPRS Pain reduction - at week 4, The Change from Baseline (average of Days -14 to -1) at Week 4 in average weekly NPRS scores in subjects treated with TTX compared to Placebo, At week 4
- Sponsor Collaborator
- Wex Pharmaceuticals Inc.
- Funded By
- INDUSTRY
- Location
- Syrentis Clinical Research, Santa Ana, California, 92705, United States|Providence Medical Foundation, Santa Rosa, California, 95403, United States|MEDSOL Clinical Research Center, Port Charlotte, Florida, 33952, United States|Care Access Research, Macon, Georgia, 31201, United States|Paradigm Clinical Research, Boise, Idaho, 83709, United States|Clinical Trials of SWLA, Lake Charles, Louisiana, 70601, United States|Barbara Ann Karmanos Cancer Institute, Detroit, Michigan, 48201, United States|St Luke's Hospital of Kansas City, Kansas City, Missouri, 64111, United States|Care Access Research, Clifton, New Jersey, 07013, United States|ES Clinical Research Group, Garden City, New York, 11530, United States|SUNY Upstate Medical University, Syracuse, New York, 13210, United States|Oncology Specialists of Charlotte, Charlotte, North Carolina, 28207, United States|Oklahoma Cancer Specialists and Research Institute (OCSRI), Tulsa, Oklahoma, 74146, United States|Center for Oncology and Blood Disorders (COBD), Houston, Texas, 77030, United States|MD Anderson Cancer Center, Houston, Texas, 77030, United States
- Other Id
- TTX-CINP-202
- Start Date
- 2022-04-19
- Primary Completion Date
- 2025-12
- Completion Date
- 2026-07
- First Posted
- 2022-05-03
- Results First Posted
- Last Update Posted
- 2024-08-09
- Study Document
- Study Url
- https://clinicaltrials.gov/study/NCT05359133
- Title Cn
- Title En
- A Randomized, Double-Blind, Placebo Controlled, Multicenter, Efficacy and Safety Trial of Single Cycle Tetrodotoxin in the Treatment of Chemotherapy Induced Neuropathic Pain
- Bilingual Status
- semi_complete