CC-10004 For The Treatment Of Vulvodynia
Primary Purpose
Vulvodynia
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
CC-10004
Sponsored by
About this trial
This is an interventional treatment trial for Vulvodynia focused on measuring vulvodynia, pelvic pain, vulvar pain
Eligibility Criteria
Inclusion Criteria:
- Participant must understand and voluntarily sign and date the appropriate Informed Consent document.
- Female who is ≥ 18 years of age and <70 years of age.
- Participant must be able to adhere to the study visit schedule and other protocol requirements.
- Participant must have vulvodynia--vulvar pain at 2 or more sites tested of at least 3 or greater on a 0-10 Likert scale.
- Subject -reported vulvar pain for at least 3 months prior to enrollment.
- Participant who is currently taking narcotics for pelvic pain must be on a stable regimen for 3 months prior to enrollment in the study.
- 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.
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:
- Pregnant or lactating females
- History of any clinically significant cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic conditions, or other major diseases
- 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
- 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.
- Positive TB skin test (Mantoux test)
- 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.
- Clinically significant abnormality on the chest x-ray (CXR) at screening.
- Use of any investigational medication within 28 days prior to randomization or 5 half-lives if known (whichever is longer)
- Any clinically significant abnormality on 12-lead ECG at screening
- Positive human immunodeficiency virus (HIV), hepatitis B, or hepatitis C laboratory test result indicating active infection at screening.
- 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)
- History of a vestibulectomy
Sites / Locations
- William Beaumont Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Study Drug CC 10004
Arm Description
Study drug CC-10004 20mg taken orally twice a day.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT00814632
First Posted
December 23, 2008
Last Updated
August 11, 2015
Sponsor
Kenneth Peters, MD
Collaborators
Celgene Corporation
1. Study Identification
Unique Protocol Identification Number
NCT00814632
Brief Title
CC-10004 For The Treatment Of Vulvodynia
Official Title
A Clinical Trial Of CC-10004 For The Treatment Of Vulvodynia
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
February 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Kenneth Peters, MD
Collaborators
Celgene Corporation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vulvodynia
Keywords
vulvodynia, pelvic pain, vulvar pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Study Drug CC 10004
Arm Type
Experimental
Arm Description
Study drug CC-10004 20mg taken orally twice a day.
Intervention Type
Drug
Intervention Name(s)
CC-10004
Other Intervention Name(s)
Study Drug
Intervention Description
CC-10004 20 mg. twice a day for 12 weeks
Primary Outcome Measure Information:
Title
Global Response Assessment
Description
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Participant must understand and voluntarily sign and date the appropriate Informed Consent document.
Female who is ≥ 18 years of age and <70 years of age.
Participant must be able to adhere to the study visit schedule and other protocol requirements.
Participant must have vulvodynia--vulvar pain at 2 or more sites tested of at least 3 or greater on a 0-10 Likert scale.
Subject -reported vulvar pain for at least 3 months prior to enrollment.
Participant who is currently taking narcotics for pelvic pain must be on a stable regimen for 3 months prior to enrollment in the study.
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.
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:
Pregnant or lactating females
History of any clinically significant cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic conditions, or other major diseases
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
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.
Positive TB skin test (Mantoux test)
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.
Clinically significant abnormality on the chest x-ray (CXR) at screening.
Use of any investigational medication within 28 days prior to randomization or 5 half-lives if known (whichever is longer)
Any clinically significant abnormality on 12-lead ECG at screening
Positive human immunodeficiency virus (HIV), hepatitis B, or hepatitis C laboratory test result indicating active infection at screening.
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)
History of a vestibulectomy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenneth M Peters, M.D.
Organizational Affiliation
Beaumont Hospitals
Official's Role
Principal Investigator
Facility Information:
Facility Name
William Beaumont Hospital
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
12. IPD Sharing Statement
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CC-10004 For The Treatment Of Vulvodynia
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