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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00380874
Registration number
NCT00380874
Ethics application status
Date submitted
25/09/2006
Date registered
27/09/2006
Date last updated
11/02/2021
Titles & IDs
Public title
Prevention And Treatment Of Chemotherapy-Induced Peripheral Neuropathy In Subjects With Advanced Colorectal Cancer
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Scientific title
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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Secondary ID [1]
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A0081124
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Chemotherapy-Induced Peripheral Neuropathy
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Condition category
Condition code
Neurological
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Other neurological disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Pregabalin
Treatment: Drugs - Placebo
Experimental: 1 - flexible dosing
Placebo Comparator: 2 -
Treatment: Drugs: Pregabalin
150- 600 mg/day (double blind in divided doses)
Treatment: Drugs: Placebo
Placebo
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Duration Adjusted Average Change (DAAC) of Paresthesia From the Onset of Chemotherapy Measured by Numeric Rating Scale (NRS)
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Assessment method [1]
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Least squares mean of change: mean at cycle minus mean at Baseline. Paresthetic duration Adjusted Average Change (DAAC) endpoint was computed based on Numeric Rating Scale (NRS) of paresthesia (collected 0=no pain; 1-3=mild pain; 4-6=moderate pain; 7-10=severe pain). DAAC endpoint is defined as the Area Under Curve (AUC) of the collected NRS over time, divided by the collection time period (up to 10 days).
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Timepoint [1]
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Period of 10 days from the onset of chemotherapy to the last cycle: Last Observation Carried Forward (LOCF)
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Secondary outcome [1]
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Duration Adjusted Average Change (DAAC) of Paresthesic Symptom Score Within Each Cycle of Chemotherapy Measured by Numeric Rating Scale (NRS)
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Assessment method [1]
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Least squares mean of change: mean at cycle minus mean at Baseline. Paresthetic Duration Adjusted Average Change (DAAC) endpoint was computed based on Numeric Rating Scale (NRS) of paresthesia (collected 0=no pain; 1-3=mild pain; 4-6=moderate pain; 7-10=severe pain). DAAC endpoint is defined as the Area Under Curve (AUC) of the collected NRS over time, divided by collection time period (up to 10 days).
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Timepoint [1]
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Baseline to Cycle 9
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Secondary outcome [2]
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Duration Adjusted Average Change (DAAC) of Dysesthesia Symptom Score Within Each Cycle of Chemotherapy Measured by Numeric Rating Scale (NRS)
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Assessment method [2]
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Least squares (LS) mean of change: mean at cycle minus mean at Baseline. Dysesthesic Duration Adjusted Average Change (DAAC) endpoint was computed based on Numeric Rating Scale (NRS) of dysesthesis (collected 0=no pain; 1-3=mild pain; 4-6=moderate pain; 7-10=severe pain). DAAC endpoint was defined as the Area Under Curve (AUC) of the collected NRS over time, divided by collection time period (up to 10 days).
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Timepoint [2]
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Baseline to Cycle 9, LOCF cycle endpoint
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Secondary outcome [3]
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Duration Adjusted Average Change (DAAC) of Pain Symptom Score Within Each Cycle of Chemotherapy Measured by Numeric Rating Scale (NRS)
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Assessment method [3]
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Least squares (LS) mean of change: mean at cycle minus mean at Baseline. Pain Duration Adjusted Average Change (DAAC) endpoint was computed based on Numeric Rating Scale (NRS) of pain (collected 0=no pain; 1-3=mild pain; 4-6=moderate pain; 7-10=severe pain). DAAC endpoint was defined as the Area Under Curve (AUC) of the collected NRS over time, divided by collection time period (up to 10 days).
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Timepoint [3]
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Baseline to Cycle 9, LOCF cycle endpoint
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Secondary outcome [4]
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Change in Pain Scores Rated on Neuropathic Pain Symptom Inventory (NPSI) Subscales From Baseline Cycle
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Assessment method [4]
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Least squares (LS) mean of change: mean at cycle minus mean at Baseline. Neuropathic Pain Symptom Inventory (NPSI) = questionnaire designed to evaluate symptoms of neuropathic pain. 11-point numeric rating scale, range: 0 (no pain) to 10 (worst pain imaginable) best describing their average pain for last 24 hours.
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Timepoint [4]
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Baseline to Cycle 9, Last Observation Carried Forward (LOCF) cycle endpoint
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Secondary outcome [5]
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Number of Participants With Persistent Paresthesic, Dysesthesic, and Pain Symptoms
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Assessment method [5]
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Number of participants with persistent paresthesic, dyesthesic, and pain symptoms at chemotherapy Cycle 9 and last observation carried forward (LOCF) endpoint. Numeric rating scale of symptoms: >=1: mild symptoms to >=4: moderate severe symptoms. Subjects rated their average severity of symptoms over the last 24 hours every evening before bedtime.
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Timepoint [5]
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Cycle 9 and Last Observation Carried Forward (LOCF) cycle endpoint
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
80
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 4
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/01/2007
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/03/2008
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Sample size
Target
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Accrual to date
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Final
64
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Recruitment in Australia
Recruitment state(s)
NSW,SA
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Recruitment hospital [1]
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Pfizer Investigational Site - St. Leonards
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Recruitment hospital [2]
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Pfizer Investigational Site - Adelaide
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Recruitment postcode(s) [1]
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2065 - St. Leonards
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Recruitment postcode(s) [2]
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5000 - Adelaide
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Recruitment outside Australia
Country [1]
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Germany
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State/province [1]
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Bielefeld
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Country [2]
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Germany
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State/province [2]
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Essen
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Country [3]
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Germany
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State/province [3]
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Hamm
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Country [4]
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Italy
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State/province [4]
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Chieti Scalo
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Country [5]
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Italy
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State/province [5]
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Potenza
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Country [6]
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Korea, Republic of
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State/province [6]
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Gyeonggi-do
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Country [7]
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Korea, Republic of
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State/province [7]
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Seoul
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Country [8]
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Spain
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State/province [8]
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Cantabria
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Country [9]
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Spain
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State/province [9]
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Alicante
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Country [10]
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Spain
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State/province [10]
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Jaen
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Country [11]
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Taiwan
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State/province [11]
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Kaohsiung Hsien
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Country [12]
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Taiwan
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State/province [12]
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Taipei
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
Prevention and treatment of the severity of symptoms of chemotherapy-induced peripheral
neuropathy.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00380874
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Pfizer CT.gov Call Center
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Address
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Pfizer
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00380874
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