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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT00380874 |
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Date of registration:
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25/09/2006 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Prevention And Treatment Of Chemotherapy-Induced Peripheral Neuropathy In Subjects With Advanced Colorectal Cancer
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Scientific title:
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A Randomized, Double-Blind, Placebo-Controlled Trial Of The Prevention And Treatment Of Chemotherapy-Induced Peripheral Neuropathy Symptoms In Subjects With Advanced Colorectal Cancer |
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Date of first enrolment:
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January 2007 |
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Target sample size:
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64 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT00380874 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 4
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Countries of recruitment
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Australia
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Germany
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Italy
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Korea, Republic of
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Spain
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Taiwan
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Contacts
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Name:
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Pfizer CT.gov Call Center |
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Address:
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Telephone:
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Email:
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Affiliation:
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Pfizer |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Diagnosis of cytological confirmed carcinoma of the Colon Stage III (Dukes C) or
metastatic Colorectal Cancer (Dukes D)
- Independent of this protocol, the patient has decided to receive standard of care for
the treatment of cancer with oxaliplatin combined with 5-fluorouracil/folinic acid
(5-FU/FA) for a minimum of 9 cycles
Exclusion Criteria:
- Presence of neuropathic pain or peripheral polyneuropathy or identified causes of
painful paresthesia including radiotherapy-induced or malignant plexopathy, lumbar or
cervical radiculopathy existing prior to baseline
- Any patients who are not suitable to be treated with either Oxaliplatin and/or 5-FU/FA
or pregabalin according to the respective local labeling
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Chemotherapy-Induced Peripheral Neuropathy
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Intervention(s)
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Drug: Pregabalin
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Drug: Placebo
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Primary Outcome(s)
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Duration Adjusted Average Change (DAAC) of Paresthesia From the Onset of Chemotherapy Measured by Numeric Rating Scale (NRS)
[Time Frame: Period of 10 days from the onset of chemotherapy to the last cycle: Last Observation Carried Forward (LOCF)]
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Secondary Outcome(s)
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Duration Adjusted Average Change (DAAC) of Pain Symptom Score Within Each Cycle of Chemotherapy Measured by Numeric Rating Scale (NRS)
[Time Frame: Baseline to Cycle 9, LOCF cycle endpoint]
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Duration Adjusted Average Change (DAAC) of Dysesthesia Symptom Score Within Each Cycle of Chemotherapy Measured by Numeric Rating Scale (NRS)
[Time Frame: Baseline to Cycle 9, LOCF cycle endpoint]
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Number of Participants With Persistent Paresthesic, Dysesthesic, and Pain Symptoms
[Time Frame: Cycle 9 and Last Observation Carried Forward (LOCF) cycle endpoint]
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Duration Adjusted Average Change (DAAC) of Paresthesic Symptom Score Within Each Cycle of Chemotherapy Measured by Numeric Rating Scale (NRS)
[Time Frame: Baseline to Cycle 9]
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Change in Pain Scores Rated on Neuropathic Pain Symptom Inventory (NPSI) Subscales From Baseline Cycle
[Time Frame: Baseline to Cycle 9, Last Observation Carried Forward (LOCF) cycle endpoint]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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