A Study to Investigate the Pharmacodynamic Effects of CT327 on Intra-dermal Nerve Growth Factor (NGF) and Evoked Pain Responses, in Healthy Male Volunteers

This study has been completed.

Sponsor:

Collaborator:

Aalborg Universityhospital

Information provided by:

Creabilis SA

ClinicalTrials.gov Identifier:

NCT01243307

First received: November 17, 2010

Last updated: June 6, 2011

Last verified: June 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	November 17, 2010
Last Updated Date	June 6, 2011
Start Date ^ICMJE	January 2011
Primary Completion Date	April 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: November 17, 2010)	An alteration in the peripheral sensitisation after treatment with CT327 [ Time Frame: 2 treatment/testing periods each lasting 4 days and separated by at least 10 days ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01243307 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: November 17, 2010)	The change in pain determined with the visual analogue scale (VAS) and the change in areas assessed with von Frey filaments and standardized brush. [ Time Frame: 2 treatment/testing periods each lasting 4 days and separated by at least 10 days ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	A Study to Investigate the Pharmacodynamic Effects of CT327 on Intra-dermal Nerve Growth Factor (NGF) and Evoked Pain Responses, in Healthy Male Volunteers
Official Title ^ICMJE	A Phase I, Single-centre, Multiple-dose, Placebo-controlled Crossover Study to Investigate the Pharmacodynamic Effects of CT327 (0.1% Topical Cream) on Intra-dermal Nerve Growth Factor (NGF) and Evoked Pain Responses, in Healthy Male Volunteers
Brief Summary	The primary objective of this study is to compare the effect of CT327 to placebo against experimental induced superficial, deep and hyperalgesic pain. The secondary objectives are to elucidate the mechanisms of CT327 using experimental pain models.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Basic Science
Condition ^ICMJE	Neuropathic Pain
Intervention ^ICMJE	Drug: CT327 (or placebo) followed by placebo (or CT327) During treatment/testing period 1, subjects will apply 0.25 g CT327 (or placebo) to 4 test fields of skin (2 on their arms and 2 on their legs) twice daily, 12 hours apart for a total of 7 applications. During treatment/testing period 2, subjects will apply 0.25 g placebo (or CT327) to 4 different test fields of skin (2 on their arms and 2 on their legs) twice daily, 12 hours apart for a total of 7 applications.
Study Arm (s)	Experimental: CT327 treatment period 1 Subjects in Group 1 will receive CT327 during treatment/testing period 1 and placebo during treatment/testing period 2 Intervention: Drug: CT327 (or placebo) followed by placebo (or CT327) Experimental: CT327 treatment period 2 Subjects in Group 2 will receive placebo during treatment/testing period 1 and CT327 during treatment/testing period 2 Intervention: Drug: CT327 (or placebo) followed by placebo (or CT327)
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Estimated Enrollment ^ICMJE	24
Completion Date	May 2011
Primary Completion Date	April 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Subjects must be able to understand the contents of the study, comply with the study and willing to sign informed consent Subjects must be free from clinically significant illness or disease as determined by their medical history, physical examination, laboratory and other tests All male subjects must take adequate contraceptive precautions during the course of the study and for 30 days after their participation in the study has ended Exclusion Criteria: Participation in other clinical studies within 3 months before screening Scheduled for surgery, medical treatment or any hospital admission that would fall within the study Use of strong painkillers Use of any analgesic within 24 hours before start of study Use of a regular course of prescribed medication and/or herbal medicine The presence of lesions, significant scars, cuts, wounds, dermal abnormalities, tattoos or naevi in the test areas A past history of contact dermatitis, psoriasis or keloid Any clinically significant ECG abnormality at screening A history of drug or other allergy that contraindicates his participation. Regular or average consumption of more than 21 units of alcohol per week (one unit of alcohol equals approximately 250 mL of beer, 125 mL of wine or 20 mL of spirits). Smokes more than five cigarettes (on average) per day, or had been a smoker of more than 5 cigarettes (on average) per day within the 3 months prior to screening. A known history of drug or alcohol abuse. As a result of the medical screening process, the PI or medical delegate considers the subject unfit for the study. Use of any prescription medication within 2 weeks or 5 half-lives (whichever is longer) of dosing. Use of non-prescription medication (e.g. aspirin, vitamins and herbal and dietary supplements) within 7 days prior to dosing, or 14 days if the medication contained grapefruit/ grapefruit juice or St John's Wort.
Gender	Male
Ages	18 Years to 64 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Denmark

Administrative Information
NCT Number ^ICMJE	NCT01243307
Other Study ID Numbers ^ICMJE	CT327-1002
Has Data Monitoring Committee	No
Responsible Party	Creabilis Therapeutics
Study Sponsor ^ICMJE	Creabilis SA
Collaborators ^ICMJE	Aalborg Universityhospital
Investigators ^ICMJE	Not Provided
Information Provided By	Creabilis SA
Verification Date	June 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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