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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
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
Sex
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
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2008
Sample size
Target
Accrual to date
Final
64
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's Upjohn has merged with Mylan to form Viatris Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00380874