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

Neuropathic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01243307
• Other study ID #: CT327-1002
• Status: Completed
• Phase: Phase 1
• First received: November 17, 2010
• Last updated: June 6, 2011
• Start date: January 2011
• Est. completion date: May 2011

Study information

• Verified date: June 2011
• Source: Creabilis SA
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: May 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 64 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Neuralgia
• Neuropathic Pain

Intervention

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.

Locations

Country	Name	City	State
Denmark	Department of Gastroenterology Aalborg Hospital	Aalborg

Sponsors (2)

Lead Sponsor	Collaborator
Creabilis SA	Aalborg Universitetshospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	An alteration in the peripheral sensitisation after treatment with CT327		2 treatment/testing periods each lasting 4 days and separated by at least 10 days	No
Secondary	The change in pain determined with the visual analogue scale (VAS) and the change in areas assessed with von Frey filaments and standardized brush.		2 treatment/testing periods each lasting 4 days and separated by at least 10 days	No