A Phase 2 interventional study of CC-10004 in Vulvodynia, sponsored by Kenneth Peters, MD. Completed at 1 site in United States. Open to female participants aged 18 Years to 69 Years. Per ClinicalTrials.gov, last updated 2015-08-13.
Sponsored by Kenneth Peters, MD · Phase 2, Interventional, and Treatment
Vulvodynia is characterized by persistent vulvar pain, which often occurs upon touch or pressure. The cause of vulvodynia is unknown but is presumed to involve many factors. Some of these factors may include altered immune response, infections, altered vaginal acid-base balance, allergic reactions and psychosexual disorders. Women are generally treated with medications such as anti-histamines, anti-depressants and anti-inflammatories, or with physical therapy to minimize symptoms. Other therapies for vulvodynia include topical agents (lidocaine, or compounded medications such as baclofen, gabapentin and amitriptyline), oral medications (gabapentin, pregabalin, calcium citrate), complementary therapies (yoga, guided imagery, cognitive behavioral therapy) or a low-oxalate diet, but these are often ineffective. Surgery for vulvodynia may be helpful in the hard to manage cases, but is utilized as a last resort.
CC-10004 is a well-tolerated, selective PDE4 inhibitor with a demonstrated inhibitory effect on inflammatory mediators and is under development for the treatment of inflammatory and immune mediated conditions.
This is an open-label, one arm, phase II study at William Beaumont Hospital. Twenty female subjects aged 18 or older meeting criteria for diagnosis of vulvodynia or vulvar vestibulitis (vestibulodynia) will be treated with CC-10004 at 20mg orally twice a day for 12 weeks.The patient will be seen for a total of ten visits by the study coordinator.
106 studies on the registry are indexed under Vulvodynia; 21 are open to participants now.
This study's enrollment of 10 is below the median of 44 across 79 interventional studies indexed under Vulvodynia.
Browse Vulvodynia studies →Kenneth Peters, MD is the lead sponsor of 14 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Subject must meet the following laboratory criteria:
Exclusion Criteria:
Study drug CC-10004 20mg taken orally twice a day.
Drug: CC-10004
CC-10004 20 mg. twice a day for 12 weeks
Also known as: Study Drug
Global Response Assessment
The primary efficacy measure was a Global Response Assessment (GRA), a subject completed questionnaire that measures improvement in overall symptoms. The GRA is a 7-point scale the allows the subject to respond to the question: "As compared to when you started the study, overall how do you feel? The responses are: Markedly Improved - 7, Moderately Improved - 6, Mildly Improved - 5, Same - 4, Mildly Worse - 3, Moderately Worse - 2, Markedly Worse - 1. The primary outcome showing response to treatment was the number of subjects that were moderately or markedly improved on the GRA scale.
Time frame: 12 weeks
| Milestone | Study Drug CC 10004 |
|---|---|
| Started | 9 |
| Completed | 7 |
| Not completed | 2 |
| Withdrew: Lack of efficacy | 2 |
The primary efficacy measure was a Global Response Assessment (GRA), a subject completed questionnaire that measures improvement in overall symptoms. The GRA is a 7-point scale the allows the subject to respond to the question: "As compared to when you started the study, overall how do you feel? The responses are: Markedly Improved - 7, Moderately Improved - 6, Mildly Improved - 5, Same - 4, Mildly Worse - 3, Moderately Worse - 2, Markedly Worse - 1. The primary outcome showing response to treatment was the number of subjects that were moderately or markedly improved on the GRA scale.
| participants | Study Drug CC 10004 |
|---|---|
| Global Response Assessment | 5 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Study Drug CC 10004 | — | 0/9 (0%) | 0/9 (0%) |
| Age, Categorical(Participants) | Study Drug CC 10004 |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 7 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | Study Drug CC 10004 |
|---|---|
| Female | 7 |
| Male | 0 |
| Region of Enrollment(participants) | Study Drug CC 10004 |
|---|---|
| United States | 7 |
This study is completed, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.
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Kenneth Peters, MD