CC-10004 For The Treatment Of Vulvodynia
Information source: William Beaumont Hospitals
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Vulvodynia
Intervention: CC-10004 (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: William Beaumont Hospitals Official(s) and/or principal investigator(s):
Kenneth M Peters, M.D., Principal Investigator, Affiliation: Beaumont Hospitals
Overall contact:
Karen Sherer, RN, Phone: 248-551-3565
Summary
Vulvodynia is characterized by persistent vulvar pain, which often occurs upon touch or
pressure. Thecause 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.
Clinical Details
Official title: A Clinical Trial Of CC-10004 For The Treatment Of Vulvodynia
Study design: Treatment, Randomized, Open Label, Placebo Control, Single Group Assignment, Safety/Efficacy Study
Primary outcome: The Global Response Assessment---subjects reporting a moderate or marked improvement will be considered responders.
Detailed description:
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 69 Years.
Gender(s): Female.
Criteria:
Inclusion Criteria:
1. Participant must understand and voluntarily sign and date the appropriate Informed
Consent document.
2. Female who is ≥ 18 years of age and <70 years of age.
3. Participant must be able to adhere to the study visit schedule and other protocol
requirements.
4. Participant must have vulvodynia--vulvar pain at 2 or more sites tested of at least 3
or greater on a 0-10 Likert scale.
5. Subject - reported vulvar pain for at least 3 months prior to enrollment.
6. Participant who is currently taking narcotics for pelvic pain must be on a stable
regimen for 3 months prior to enrollment in the study.
7. Females of childbearing potential (FCBP) must have a negative urine pregnancy test at
screening/baseline (Visit 1). In addition, sexually active FCBP must agree to use
TWO of the following adequate forms of contraception while on study medication: oral,
injectable, or implantable hormonal contraceptives; tubal ligation; intrauterine
device; barrier contraceptive with spermicide; or vasectomized partner. A FCBP must
agree to have pregnancy tests every 28 days while on study medication.
8. Subject must meet the following laboratory criteria:
- Hemoglobin > 9 g/dL
- Hematocrit ≥ 27%
- White blood cell (WBC) count ≥ 3000 /mL (≥ 3. 0 X 109/L) and < 20,000/mL (< 20 X
109/L)
- Neutrophils ≥ 1500 /mL (≥ 1. 5 X 109/L)
- Platelets ≥ 100,000 /mL (≥ 100 X 109/L)
- Serum creatinine ≤ 1. 5 mg/dL (≤ 132. 6 μmol/L)
- Total bilirubin £ 2. 0 mg/dL
- Aspartate transaminase (AST [serum glutamic oxaloacetic transaminase, SGOT]) and
alanine transaminase (ALT [serum glutamate pyruvic transaminase, SGPT]) < 1. 5x
upper limit of normal (ULN)
Exclusion Criteria:
1. Pregnant or lactating females
2. History of any clinically significant cardiac, endocrinologic, pulmonary, neurologic,
psychiatric, hepatic, renal, hematologic, immunologic conditions, or other major
diseases
3. Any condition, including the presence of laboratory abnormalities, which places the
subject at unacceptable risk if he/she were to participate in the study or confounds
the ability to interpret data from the study
4. History of active Mycobacterium tuberculosis infection (any subspecies) within 3
years prior to the screening visit. Infections that occurred > 3 years prior to
entry must have been effectively treated.
5. Positive TB skin test (Mantoux test)
6. History of incompletely treated latent Mycobacterium tuberculosis infection as
indicated by a positive positive Purified Protein Derivative [PPD] skin test or in
vitro test [T-SPOT®. TB, QuantiFERON Gold®] or chest x-ray.
7. Clinically significant abnormality on the chest x-ray (CXR) at screening.
8. Use of any investigational medication within 28 days prior to randomization or 5
half-lives if known (whichever is longer)
9. Any clinically significant abnormality on 12-lead ECG at screening
10. Positive human immunodeficiency virus (HIV), hepatitis B, or hepatitis C laboratory
test result indicating active infection at screening.
11. History of malignancy within previous 5 years (except for treated basal-cell skin
carcinoma(s) and/or fewer than 3 treated squamous-cell skin carcinomas)
12. History of a vestibulectomy
Locations and Contacts
Karen Sherer, RN, Phone: 248-551-3565
William Beaumont Hospital, Royal Oak, Michigan 48073, United States; Recruiting
Karen Sherer, RN, Phone: 248-551-3565
Kenneth M Peters, M.D., Principal Investigator
Additional Information
Starting date: December 2008
Ending date: December 2011
Last updated: July 24, 2009
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