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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00380874




Registration number
NCT00380874
Ethics application status
Date submitted
25/09/2006
Date registered
27/09/2006
Date last updated
7/10/2009

Titles & IDs
Public title
Prevention And Treatment Of Chemotherapy-Induced Peripheral Neuropathy In Subjects With Advanced Colorectal Cancer
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
Secondary ID [1] 0 0
A0081124
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chemotherapy-Induced Peripheral Neuropathy 0 0
Condition category
Condition code
Cancer 0 0 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
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

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Duration Adjusted Average Change (DAAC) of Paresthesia From the Onset of Chemotherapy Measured by Numeric Rating Scale (NRS)
Timepoint [1] 0 0
Period of 10 days from the onset of chemotherapy to the last cycle: Last Observation Carried Forward (LOCF)
Secondary outcome [1] 0 0
Duration Adjusted Average Change (DAAC) of Paresthesic Symptom Score Within Each Cycle of Chemotherapy Measured by Numeric Rating Scale (NRS)
Timepoint [1] 0 0
Baseline to Cycle 9
Secondary outcome [2] 0 0
Duration Adjusted Average Change (DAAC) of Dysesthesia Symptom Score Within Each Cycle of Chemotherapy Measured by Numeric Rating Scale (NRS)
Timepoint [2] 0 0
Baseline to Cycle 9, LOCF cycle endpoint
Secondary outcome [3] 0 0
Duration Adjusted Average Change (DAAC) of Pain Symptom Score Within Each Cycle of Chemotherapy Measured by Numeric Rating Scale (NRS)
Timepoint [3] 0 0
Baseline to Cycle 9, LOCF cycle endpoint
Secondary outcome [4] 0 0
Change in Pain Scores Rated on Neuropathic Pain Symptom Inventory (NPSI) Subscales From Baseline Cycle
Timepoint [4] 0 0
Baseline to Cycle 9, Last Observation Carried Forward (LOCF) cycle endpoint
Secondary outcome [5] 0 0
Number of Participants With Persistent Paresthesic, Dysesthesic, and Pain Symptoms
Timepoint [5] 0 0
Cycle 9 and Last Observation Carried Forward (LOCF) cycle endpoint

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
Minimum age
18 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA
Recruitment hospital [1] 0 0
Pfizer Investigational Site - St. Leonards
Recruitment hospital [2] 0 0
Pfizer Investigational Site - Adelaide
Recruitment postcode(s) [1] 0 0
2065 - St. Leonards
Recruitment postcode(s) [2] 0 0
5000 - Adelaide
Recruitment outside Australia
Country [1] 0 0
Germany
State/province [1] 0 0
Bielefeld
Country [2] 0 0
Germany
State/province [2] 0 0
Essen
Country [3] 0 0
Germany
State/province [3] 0 0
Hamm
Country [4] 0 0
Italy
State/province [4] 0 0
Chieti Scalo
Country [5] 0 0
Italy
State/province [5] 0 0
Potenza
Country [6] 0 0
Korea, Republic of
State/province [6] 0 0
Gyeonggi-do
Country [7] 0 0
Korea, Republic of
State/province [7] 0 0
Seoul
Country [8] 0 0
Spain
State/province [8] 0 0
Cantabria
Country [9] 0 0
Spain
State/province [9] 0 0
Alicante
Country [10] 0 0
Spain
State/province [10] 0 0
Jaen
Country [11] 0 0
Taiwan
State/province [11] 0 0
Kaohsiung Hsien
Country [12] 0 0
Taiwan
State/province [12] 0 0
Taipei

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Prevention and treatment of the severity of symptoms of chemotherapy-induced peripheral
neuropathy.
Trial website
https://clinicaltrials.gov/show/NCT00380874
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT00380874