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Prevention And Treatment Of Chemotherapy-Induced Peripheral Neuropathy In Subjects With Advanced Colorectal Cancer

Last updated on May 12, 2018

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Study Location
Pfizer Investigational Site
St. Leonards, New South Wales, 2065 Australia
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Chemotherapy-Induced Peripheral Neuropathy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-80 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT00380874
Pfizer
Terminated
Prevention And Treatment Of Chemotherapy-Induced Peripheral Neuropathy In Subjects With Advanced Colorectal Cancer

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Prevention And Treatment Of Chemotherapy-Induced Peripheral Neuropathy In Subjects With Advanced Colorectal Cancer
A Randomized, Double-Blind, Placebo-Controlled Trial Of The Prevention And Treatment Of Chemotherapy-Induced Peripheral Neuropathy Symptoms In Subjects With Advanced Colorectal Cancer
Prevention and treatment of the severity of symptoms of chemotherapy-induced peripheral neuropathy.
This study was terminated on July 15, 2008. The results of an interim analysis showed that the conditional power to detect a difference in treatment groups was insufficient to warrant study continuation and therefore termination of the trial was recommended. The decision to terminate the trial was not based on safety concerns.
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Chemotherapy-Induced Peripheral Neuropathy
  • Drug: Pregabalin
    150- 600 mg/day (double blind in divided doses)
    Other Name: Chemotherapy
  • Drug: Placebo
    Placebo
    Other Name: Chemotherapy
  • Experimental: 1
    flexible dosing
    Intervention: Drug: Pregabalin
  • Placebo Comparator: 2
    Intervention: Drug: Placebo
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
64
March 2008
March 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Germany,   Italy,   Korea, Republic of,   Spain,   Taiwan
 
 
NCT00380874
A0081124
Yes
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2009

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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