Neuropathic PainPhase 1NCT01243307
A Study to Investigate the Pharmacodynamic Effects of CT327 on Intra-dermal Nerve Growth Factor (NGF) and Evoked Pain Responses, in Healthy Male Volunteers
A Phase 1 study of Neuropathic Pain, run by Creabilis SA at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 to 64 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Neuropathic Pain
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2011to May 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Neuropathic Pain
- Being tested
- CT327 (or placebo) followed by placebo (or CT327)
- Medical subject headings
- Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT327 (or placebo) followed by placebo (or CT327)Drug
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 group | Role | What they receive |
|---|---|---|
| CT327 treatment period 1 | Experimental | Subjects in Group 1 will receive CT327 during treatment/testing period 1 and placebo during treatment/testing period 2 Receives: Drug: CT327 (or placebo) followed by placebo (or CT327) |
| CT327 treatment period 2 | Experimental | Subjects in Group 2 will receive placebo during treatment/testing period 1 and CT327 during treatment/testing period 2 Receives: Drug: CT327 (or placebo) followed by placebo (or CT327) |
What is being measured
The primary outcome is the main question the study is designed to answer.
An alteration in the peripheral sensitisation after treatment with CT327
Measured: 2 treatment/testing periods each lasting 4 days and separated by at least 10 days
Secondary outcomes (1)
The change in pain determined with the visual analogue scale (VAS) and the change in areas assessed with von Frey filaments and standardized brush.
Measured: 2 treatment/testing periods each lasting 4 days and separated by at least 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2010 (estimated)
- Study startJan 2011
- Primary completionApr 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuropathic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Creabilis SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Aalborg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01243307
- Sponsor's protocol ID
- CT327-1002
- Status last verified
- Jun 2011
- First submitted
- 17 Nov 2010
- Last updated
- 8 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01243307
- Acronym / sponsor ID
- CT327-1002
- Conditions
- Neuropathic Pain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Creabilis SAIndustry (pharma, biotech, devices)
- Collaborators
- Aalborg University Hospital
- Study start
- Jan 2011
- Primary completion
- Apr 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 18 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CT327 treatment period 1 | Experimental | Drug: CT327 (or placebo) followed by placebo (or CT327)Subjects in Group 1 will receive CT327 during treatment/testing period 1 and placebo during treatment/testing period 2 |
| CT327 treatment period 2 | Experimental | Drug: CT327 (or placebo) followed by placebo (or CT327)Subjects in Group 2 will receive placebo during treatment/testing period 1 and CT327 during treatment/testing period 2 |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | CT327 treatment period 1, CT327 treatment period 2 |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study of Neuropathic Pain, run by Creabilis SA at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2011.