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

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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

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Chemotherapy-Induced Peripheral Neuropathy
Interventions: Drug: Pregabalin
Drug: Placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of the 69 subjects screened, 64 were randomized, and 61 received treatment. Of the 8 subjects screened but not treated, 1 was ineligible due to an abnormal laboratory test result, 6 were ineligible due to a reason categorized as other, and 1 was no longer willing to continue in the study.

Reporting Groups
  Description
Pregabalin Pregabalin 150 to 600 milligrams per day (mg/day) flexible dose + chemotherapy (oxaliplatin combined with 5-fluorouracil/folinic acid (5-FU/FA). Possible dose levels of pregabalin were 150 mg/day (75 mg capsules twice a day [BID]), 300 mg/day (150 mg capsules BID) or 600 mg/day (300 mg capsules BID).
Placebo matching placebo + chemotherapy (oxaliplatin combined with 5-fluorouracil/folinic acid (5-FU/FA).

Participant Flow:   Overall Study
    Pregabalin   Placebo
STARTED   32   29 
COMPLETED   19   19 
NOT COMPLETED   13   10 
Adverse Event                7                7 
Death                1                0 
Withdrawal by Subject                2                1 
Not related to study drug                3                2 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Pregabalin Pregabalin 150 to 600 milligrams per day (mg/day) flexible dose + chemotherapy (oxaliplatin combined with 5-fluorouracil/folinic acid (5-FU/FA). Possible dose levels of pregabalin were 150 mg/day (75 mg capsules twice a day [BID]), 300 mg/day (150 mg capsules BID) or 600 mg/day (300 mg capsules BID).
Placebo matching placebo + chemotherapy (oxaliplatin combined with 5-fluorouracil/folinic acid (5-FU/FA).
Total Total of all reporting groups

Baseline Measures
   Pregabalin   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 32   29   61 
Age 
[Units: Years]
Mean (Standard Deviation)
 58.9  (11.3)   56.1  (12.9)   57.6  (12.0) 
Gender 
[Units: Participants]
     
Female   11   8   19 
Male   21   21   42 


  Outcome Measures

1.  Primary:   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) ]

2.  Secondary:   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 ]

3.  Secondary:   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 ]

4.  Secondary:   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 ]

5.  Secondary:   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 ]

6.  Secondary:   Number of Participants With Persistent Paresthesic, Dysesthesic, and Pain Symptoms   [ Time Frame: Cycle 9 and Last Observation Carried Forward (LOCF) cycle endpoint ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Due to lack of symptom emergence, enrollment was halted, and endpoint modified because primary assumptions upon which it was powered (emergence of symptomatology) were not met, and not all endpoints were able to be reliably analyzed.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc
phone: 1-800-718-1021
e-mail: ClinicalTrials.govCallCenter@pfizer.com



Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00380874     History of Changes
Other Study ID Numbers: A0081124
First Submitted: September 25, 2006
First Posted: September 27, 2006
Results First Submitted: March 10, 2009
Results First Posted: April 17, 2009
Last Update Posted: October 7, 2009