Study of NGX-4010 for the Treatment of Painful HIV-Associated Neuropathy

This study has been completed.

Study NCT00321672 Information provided by NeurogesX

First Received on May 2, 2006. Last Updated on May 13, 2011 History of Changes

Results First Received: June 16, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Conditions:	Pain HIV Infections Peripheral Nervous System Diseases
Interventions:	Drug: NGX-4010, 8% capsaicin patch Drug: 0.04% capsaicin patch

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
NGX-4010, 60 Minutes	Treatment with capsaicin patches consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive NGX 4010 (high concentration capsaicin, 640 mcg/cm^2) for 60 minutes.
Control Group, 60 Minutes	Treatment consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive a Control patch (low concentration capsaicin, 3.2 mcg/cm^2) for 60 minutes. The low dose of 3.2 mcg/cm^2 (0.04% w/w) used as the Control in this study was selected because it was expected to cause perceptible local sensation, thereby preserving the blind.
NGX-4010, 30 Minutes	Treatment with capsaicin patches consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive NGX 4010 (high concentration capsaicin, 640 mcg/cm^2) for 30 minutes.
Control Group , 30 Minutes	Treatment consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive a Control patch (low concentration capsaicin, 3.2 mcg/cm^2) for 30 minutes. The low dose of 3.2 mcg/cm^2 (0.04% w/w) used as the Control in this study was selected because it was expected to cause perceptible local sensation, thereby preserving the blind.

Participant Flow: Overall Study

	NGX-4010, 60 Minutes	Control Group, 60 Minutes	NGX-4010, 30 Minutes	Control Group , 30 Minutes
STARTED	165	89 ^[1]	167	73 ^[1]
COMPLETED	153	81	156	71
NOT COMPLETED	12	8	11	2
Withdrawal by Subject	5	1	2	0
Noncompliance	1	2	1	0
Adverse Event	1	1	0	0
Lack of Efficacy	1	1	0	0
Lost to Follow-up	2	0	4	2
Death	1	0	0	0
Too far to travel for visits	1	0	0	0
Incarcerated	0	0	2	0
Moved out of state	0	1	1	0
Protocol Violation	0	0	1	0
Diagnosis of testicular cancer	0	1	0	0
Extensive travel required for new job	0	1	0	0

[1]	One randomized to 30 minutes received 60 minutes. Under 30 for efficacy and under 60 for safety.

Baseline Characteristics

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Reporting Groups

	Description
NGX-4010, 60 Minutes	Treatment with capsaicin patches consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive NGX 4010 (high concentration capsaicin, 640 mcg/cm^2) for 60 minutes.
Control Group, 60 Minutes	Treatment consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive a Control patch (low concentration capsaicin, 3.2 mcg/cm^2) for 60 minutes. The low dose of 3.2 mcg/cm^2 (0.04% w/w) used as the Control in this study was selected because it was expected to cause perceptible local sensation, thereby preserving the blind.
NGX-4010, 30 Minutes	Treatment with capsaicin patches consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive NGX 4010 (high concentration capsaicin, 640 mcg/cm^2) for 30 minutes.
Control Group , 30 Minutes	Treatment consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive a Control patch (low concentration capsaicin, 3.2 mcg/cm^2) for 30 minutes. The low dose of 3.2 mcg/cm^2 (0.04% w/w) used as the Control in this study was selected because it was expected to cause perceptible local sensation, thereby preserving the blind.

Baseline Measures

	NGX-4010, 60 Minutes	Control Group, 60 Minutes	NGX-4010, 30 Minutes	Control Group , 30 Minutes	Total
Number of Participants [units: participants]	165	90	167	72	494
Age ^[1] [units: years] Mean ± Standard Deviation	49.0 ± 8.52	50.1 ± 9.33	50.5 ± 8.34	49.3 ± 7.78	49.7 ± 8.5
Gender ^[1] [units: participants]
Female	17	11	25	9	62
Male	148	79	142	63	432

[1]	60 minutes control group - one randomized 30 minutes received 60 minutes. Under 30 for efficacy and under 60 30 minutes control goup, one randomized to 30 minutes received 60 minutes. Under 30 for efficacy and under 60 for safety.

Outcome Measures

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1. Primary:

The Primary Measure of Efficacy Was the Percent Change in the “Average Pain for the Past 24 Hours” Numeric Pain Rating Scale (NPRS) Score From Baseline During Weeks 2 to 12. [ Time Frame: Weeks 2-12 ]

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2. Secondary:

Absolute Change in the Mean “Average Pain for the Past 24 Hours” Numeric Pain Rating Scale (NPRS) Score From Baseline During Weeks 2 to 12. [ Time Frame: Weeks 2-12. ]

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3. Secondary:

Proportion of Subjects Reaching 30% Decrease in Their Mean “Average Pain for the Past 24 Hours” Numeric Pain Rating Scale (NPRS) Score From Baseline During Weeks 2 to 12 [ Time Frame: Weeks 2-12 ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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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: 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 from the time submitted to the sponsor for review. The PI shall comply with the sponsor's requests to delete references to trade secrets, intellectual properties or other proprietary information.

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
Differences between the 60- and 30-minute Control groups prevented pooling according to prespecified criteria resulting in treatment comparisons between 60- and 30-minute NGX-4010 groups and their respective Control groups with relatively low power.

Results Point of Contact:

Name/Title: Trudy Vanhove, VP Clinical Development
Organization: NeurogesX
phone: 650-393-7444
e-mail: tvanhove@neurogesx.com

No publications provided

Responsible Party:	Trudy Vanhove, VP Clinical Development, NeurogesX
ClinicalTrials.gov Identifier:	NCT00321672 History of Changes
Other Study ID Numbers:	C119
Study First Received:	May 2, 2006
Results First Received:	June 16, 2010
Last Updated:	May 13, 2011
Health Authority:	United States: Food and Drug Administration