Prevention And Treatment Of Chemotherapy-Induced Peripheral Neuropathy In Subjects With Advanced Colorectal Cancer
This study has been terminated.
(See detailed description for termination reason)
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00380874
First received: September 25, 2006
Last updated: October 1, 2009
Last verified: October 2009
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Purpose
Prevention and treatment of the severity of symptoms of chemotherapy-induced peripheral neuropathy.
| Condition | Intervention | Phase |
|---|---|---|
|
Chemotherapy-Induced Peripheral Neuropathy |
Drug: Pregabalin Drug: Placebo |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
Charcot-Marie-Tooth disease
hereditary neuropathy with liability to pressure palsies
Drug Information available for:
Pregabalin
U.S. FDA Resources
Further study details as provided by Pfizer:
Primary Outcome Measures:
- 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) ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- Number of Participants With Persistent Paresthesic, Dysesthesic, and Pain Symptoms [ Time Frame: Cycle 9 and Last Observation Carried Forward (LOCF) cycle endpoint ] [ Designated as safety issue: No ]
| Enrollment: | 64 |
| Study Start Date: | January 2007 |
| Study Completion Date: | March 2008 |
| Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
flexible dosing
|
Drug: Pregabalin
150- 600 mg/day (double blind in divided doses)
Other Name: Chemotherapy
|
| Placebo Comparator: 2 |
Drug: Placebo
Placebo
Other Name: Chemotherapy
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00380874
Locations
| Australia, New South Wales | |
| Pfizer Investigational Site | |
| St. Leonards, New South Wales, Australia, 2065 | |
| Australia, South Australia | |
| Pfizer Investigational Site | |
| Adelaide, South Australia, Australia, 5000 | |
| Germany | |
| Pfizer Investigational Site | |
| Bielefeld, Germany, 33611 | |
| Pfizer Investigational Site | |
| Essen, Germany, 45122 | |
| Pfizer Investigational Site | |
| Hamm, Germany, 59071 | |
| Italy | |
| Pfizer Investigational Site | |
| Chieti Scalo, Italy, 66013 | |
| Pfizer Investigational Site | |
| Potenza, Italy, 85100 | |
| Korea, Republic of | |
| Pfizer Investigational Site | |
| Goyang-si, Gyeonggi-do, Korea, Republic of, 411-769 | |
| Pfizer Investigational Site | |
| Seoul, Korea, Republic of, 130-702 | |
| Pfizer Investigational Site | |
| Seoul, Korea, Republic of, 137-701 | |
| Spain | |
| Pfizer Investigational Site | |
| Santander, Cantabria, Spain, 39008 | |
| Pfizer Investigational Site | |
| Alicante, Spain, 03010 | |
| Pfizer Investigational Site | |
| Jaen, Spain, 23007 | |
| Taiwan | |
| Pfizer Investigational Site | |
| Niao-Sung Hsiang, Kaohsiung Hsien, Taiwan | |
| Pfizer Investigational Site | |
| Taipei, Taiwan, 10449 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer, Inc. |
| ClinicalTrials.gov Identifier: | NCT00380874 History of Changes |
| Other Study ID Numbers: | A0081124 |
| Study First Received: | September 25, 2006 |
| Results First Received: | March 10, 2009 |
| Last Updated: | October 1, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Pfizer:
|
Pain chemotherapy |
Additional relevant MeSH terms:
|
Colorectal Neoplasms Peripheral Nervous System Diseases Demyelinating Diseases Polyneuropathies Nerve Compression Syndromes Neurologic Manifestations Neurotoxicity Syndromes Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases |
Intestinal Diseases Rectal Diseases Neuromuscular Diseases Nervous System Diseases Signs and Symptoms Poisoning Substance-Related Disorders Pregabalin Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013