Postherpetic NeuralgiaPhase 2NCT00576108
A 2 Week Study of Topical KD7040 in the Treatment of Postherpetic Neuralgia (PHN)
A Phase 2 study testing KD7040 Topical Gel in people with Postherpetic Neuralgia and Shingles, run by Kalypsys, Inc. at 1 site in United States.
Trial summary
This study will evaluate the safety and efficacy of 2 weeks of topical KD7040 versus placebo in the treatment of postherpetic neuralgia. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Postherpetic Neuralgia, Shingles, Herpes Zoster
- What is being tested?
- KD7040 Topical Gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2007to Jul 2008
- Phase
- Phase 2
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects ages 18-85 years
- Previous diagnosis of Shingles (Herpes Zoster) with pain persisting for at least 3 months, but not longer than 5 years, after healing of rash
- Subject with intact skin in the targeted treatment area
- Female subjects of childbearing potential must have a negative serum pregnancy test at screening, a negative urine human chorionic gonadotropin (hCG) test prior to randomization, and must use medically acceptable methods of birth control. All subjects must agree to take every precaution to ensure that pregnancy will not occur during the study.
- Subject must be willing and able to complete screening and study procedures as described int he protocol.
- Subject must voluntarily provide written Informed Consent prior to participation.
Who cannot join
- Subjects with known hypersensitivity to KD7040 or methylparaben, or previous exposure to KD7040.
- Subjects pregnant, nursing or planning to become pregnant.
- Subjects who are immunocompromised or have clinically significant hematological abnormalities.
- Subjects with system dermatological conditions (e.g., psoriasis, atopic dermatitis) or impaired wound healing.
- Subjects who have had local anesthetic nerve blocks within 48 hours of study entry.
- Subjects having other sever pain which may confound assessment of PHN.
- Subjects who have serious, unstable, or clinically significant medical or psychological conditions, which, in the opinion of the Investigator(s) would compromise the subjects' participation in the study.
Trial locations and contacts
1 site in 1 country.
About this study
This study will evaluate the safety and efficacy of 2 weeks of topical KD7040 versus placebo in the treatment of postherpetic neuralgia.
- Conditions
- Postherpetic Neuralgia, Shingles, Herpes Zoster, Neuropathic Pain
- Being tested
- KD7040 Topical Gel, Placebo gel
- Medical subject headings
- Neuralgia, Postherpetic, Herpes Zoster, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KD7040 Topical GelDrug
KD7040 topical gel
Placebo gelDrug
Placebo gel
| Study group | Role | What they receive |
|---|---|---|
| KD7040 topical gel | Experimental | Not described Receives: Drug: KD7040 Topical Gel |
| Placebo gel | Placebo comparator | Not described Receives: Drug: Placebo gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Worst daily pain
Measured: Once daily
Secondary outcomes (1)
Average daily pain
Measured: Once daily
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2007 (estimated)
- Study startNov 2007
- Primary completionJul 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postherpetic NeuralgiaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kalypsys, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00576108
- Sponsor's protocol ID
- KD7040-NP02
- Status last verified
- Jul 2008
- First submitted
- 14 Dec 2007
- Last updated
- 22 Jul 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 2 Week Study of Topical KD7040 in the Treatment of Postherpetic Neuralgia (PHN)
- ClinicalTrials.gov ID
- NCT00576108
- Acronym / sponsor ID
- KD7040-NP02
- Conditions
- Postherpetic Neuralgia, Shingles, Herpes Zoster, Neuropathic Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Kalypsys, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2007
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 18 Dec 2007 (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.
This study will evaluate the safety and efficacy of 2 weeks of topical KD7040 versus placebo in the treatment of postherpetic neuralgia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KD7040 topical gel | Experimental | Drug: KD7040 Topical Gel |
| Placebo gel | Placebo comparator | Drug: Placebo gel |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female subjects ages 18-85 years
- Previous diagnosis of Shingles (Herpes Zoster) with pain persisting for at least 3 months, but not longer than 5 years, after healing of rash
- Subject with intact skin in the targeted treatment area
- Female subjects of childbearing potential must have a negative serum pregnancy test at screening, a negative urine human chorionic gonadotropin (hCG) test prior to randomization, and must use medically acceptable methods of birth control. All subjects must agree to take every precaution to ensure that pregnancy will not occur during the study.
- Subject must be willing and able to complete screening and study procedures as described int he protocol.
Key exclusion criteria (7 listed)
- Subjects with known hypersensitivity to KD7040 or methylparaben, or previous exposure to KD7040.
- Subjects pregnant, nursing or planning to become pregnant.
- Subjects who are immunocompromised or have clinically significant hematological abnormalities.
- Subjects with system dermatological conditions (e.g., psoriasis, atopic dermatitis) or impaired wound healing.
- Subjects who have had local anesthetic nerve blocks within 48 hours of study entry.
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 |
|---|---|---|
| KD7040 Topical GelKD7040 topical gel | Drug | KD7040 topical gel |
| Placebo gelPlacebo gel | Drug | Placebo gel |
Primary outcome
Worst daily pain
Time frame: Once daily
1 secondary outcome
Average daily pain
Time frame: Once daily
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 22 Jul 2008.
Related trials for Postherpetic Neuralgia
Not yet recruitingPhase 1
Simultaneous Engagement of Networks for Alleviating Pain (SENAP)
Neuropathic Pain, Postherpetic Neuralgia
Active, not recruiting
Transcranial Magnetic Stimulation for Chronic Neuropathic Pain
Chronic Neuropathic Pain, Post-Stroke Pain
Active, not recruitingObservational study
Obesity and Obesity-Related Factors and Risk of Herpes Zoster (Shingles) and Postherpetic Neuralgia
Herpes Zoster (HZ)
Recruiting
The Analgesic Efficacy and Safety of Venlafaxine for Prevention of Postherpetic Neuralgia in Patients With Acute Herpes Zoster
Herpes Zoster, Pain
Not yet recruiting
Efficacy and Safety of Intravenous Dexamethasone Palmitate Treatments in Acute and Subacute Herpes Zoster Pain
Herpes Zoster Pain
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 2 study testing KD7040 Topical Gel in people with Postherpetic Neuralgia and Shingles, run by Kalypsys, Inc. at 1 site in United States.
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 6 inclusion and 7 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 22 Jul 2008. 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 United States. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Worst daily pain (time frame: Once daily). 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 22 Jul 2008.