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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00380874
Recruitment Status : Terminated (See detailed description for termination reason)
First Posted : September 27, 2006
Results First Posted : April 17, 2009
Last Update Posted : October 7, 2009
Sponsor:
Information provided by:
Pfizer

Brief Summary:
Prevention and treatment of the severity of symptoms of chemotherapy-induced peripheral neuropathy.

Condition or disease Intervention/treatment Phase
Chemotherapy-Induced Peripheral Neuropathy Drug: Pregabalin Drug: Placebo Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : January 2007
Actual Primary Completion Date : March 2008
Actual Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Pregabalin

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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) ]
    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).


Secondary Outcome Measures :
  1. 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 ]
    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).

  2. 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 ]
    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).

  3. 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 ]
    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).

  4. 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 ]
    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.

  5. Number of Participants With Persistent Paresthesic, Dysesthesic, and Pain Symptoms [ Time Frame: Cycle 9 and Last Observation Carried Forward (LOCF) cycle endpoint ]
    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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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00380874


Locations
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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
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Study Director: Pfizer CT.gov Call Center Pfizer
Additional Information:
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Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00380874    
Other Study ID Numbers: A0081124
First Posted: September 27, 2006    Key Record Dates
Results First Posted: April 17, 2009
Last Update Posted: October 7, 2009
Last Verified: October 2009
Keywords provided by Pfizer:
Pain
chemotherapy
Additional relevant MeSH terms:
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Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Pregabalin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs