Symptomatic Treatment Of Patients With Neuropathic Pain With LYRICA (NI-PMS)

This study has been completed.

Sponsor:

Information provided by:

Pfizer

ClinicalTrials.gov Identifier:

NCT00843284

First received: February 12, 2009

Last updated: October 21, 2009

Last verified: October 2009

History of Changes

Results First Received: March 11, 2009

Study Type:	Observational
Study Design:	Time Perspective: Prospective
Condition:	Neuropathic Pain
Intervention:	Drug: Pregabalin

Participant Flow

Hide Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study was conducted at 23 sites in Greece by investigators contracted by and under the direction of the sponsor. This study was performed by office-based physicians and in hospitals.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
This study enrolled subjects with a confirmed diagnosis of neuropathic pain, according to the neuropathic pain diagnostic (DN4) Questionnaire, completed by the investigator at baseline

Reporting Groups

	Description
Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses)	275 subjects received pregabalin alone while 416 subjects received pregabalin in combination with another neuropathic pain medication.

Participant Flow: Overall Study

	Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses)
STARTED	691
COMPLETED	619
NOT COMPLETED	72
Adverse Event	39
Lack of Efficacy	5
Lost to Follow-up	11
Other	10
Withdrawal by Subject	4
Death	3

Baseline Characteristics

Hide Baseline Characteristics

Reporting Groups

	Description
Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses)	275 subjects received pregabalin alone while 416 subjects received pregabalin in combination with another neuropathic pain medication.

Baseline Measures

	Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses)
Number of Participants [units: participants]	691
Age [units: years] Mean ± Standard Deviation	62.9 ± 13.7
Gender, Customized [units: participants]
Female	434
Male	254
Unspecified	3

Outcome Measures

Show All Outcome Measures

1. Primary:

Daily Average Pain Scores [ Time Frame: Baseline, Final Visit (Week 8 or discontinuation) ]

Show Outcome Measure 1

2. Primary:

Pain Related Sleep Interference [ Time Frame: Baseline, Final Visit (Week 8 or discontinuation) ]

Show Outcome Measure 2

3. Secondary:

Anxiety and Depression Symptoms [ Time Frame: Baseline, Final Visit (Week 8 or discontinuation) ]

Show Outcome Measure 3

4. Secondary:

Clinician Global Improvement of Change (CGIC) at Final Visit (Week 8 or Discontinuation) [ Time Frame: Final Visit (Week 8 or discontinuation) ]

Show Outcome Measure 4

5. Secondary:

Patient Global Improvement of Change (PGIC) at Final Visit (Week 8 or Discontinuation) [ Time Frame: Final Visit (Week 8 or discontinuation) ]

Show Outcome Measure 5

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

More Information

Hide 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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Pfizer has the right to review disclosures, requesting a delay of <60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), <12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential info other than study results.

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
No text entered.

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

No publications provided

Responsible Party:	Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier:	NCT00843284 History of Changes
Other Study ID Numbers:	A0081139, ATLAS
Study First Received:	February 12, 2009
Results First Received:	March 11, 2009
Last Updated:	October 21, 2009
Health Authority:	Greece: Ethics Committee

To Top