A Study of the Efficacy and Safety of Amitriptyline/Ketamine Topical Cream in Patients With Diabetic Peripheral Neuropathy

This study has been completed.

Study NCT00476151 Information provided by EpiCept Corporation

First Received on May 17, 2007. Last Updated on April 19, 2011 History of Changes

Results First Received: September 28, 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:	Diabetic Peripheral Neuropathy Neuralgia
Interventions:	Drug: EpiCept NP-1 (4% Amitriptyline/ 2% Ketamine) Topical Cream Drug: placebo cream

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
Placebo Cream	vehicle cream applied twice daily for 4 weeks
Amitriptyline 4% Ketamine 2% Cream	active topical cream applied twice daily for 4 weeks

Participant Flow: Overall Study

	Placebo Cream	Amitriptyline 4% Ketamine 2% Cream
STARTED	112	114
COMPLETED	109	107
NOT COMPLETED	3	7
Adverse Event	0	2
Protocol Violation	1	3
Withdrawal by Subject	2	0
Physician Decision	0	2

Baseline Characteristics

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Reporting Groups

	Description
Placebo Cream	vehicle cream applied twice daily for 4 weeks
Amitriptyline 4% Ketamine 2% Cream	active topical cream applied twice daily for 4 weeks

Baseline Measures

	Placebo Cream	Amitriptyline 4% Ketamine 2% Cream	Total
Number of Participants [units: participants]	112	114	226
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	86	94	180
>=65 years	26	20	46
Age [units: years] Mean ± Standard Deviation	55.05 ± 11.044	56.06 ± 9.350	55.56 ± 10.214
Gender [units: participants]
Female	55	49	104
Male	57	65	122
Region of Enrollment [units: participants]
India	112	114	226

Outcome Measures

1. Primary:

Placebo vs. Active Comparison of the Change From Average Pain at Baseline to Average Pain at 4 Weeks. [ Time Frame: baseline and 4 weeks treatment ]

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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 NOT 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.

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
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Results Point of Contact:

Name/Title: Chief Medical Officer
Organization: EpiCept Corporation
phone: 914-606-3500
e-mail: deverton@epicept.com

No publications provided

Responsible Party:	Stephane Allard, Chief Medical Officer, EpiCept Corporation
ClinicalTrials.gov Identifier:	NCT00476151 History of Changes
Other Study ID Numbers:	EPC2006-01
Study First Received:	May 17, 2007
Results First Received:	September 28, 2010
Last Updated:	April 19, 2011
Health Authority:	United States: Food and Drug Administration; India: Ministry of Health