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Trial record 83 of 135 for:    AMITRIPTYLINE

CC-10004 For The Treatment Of Vulvodynia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00814632
Recruitment Status : Completed
First Posted : December 25, 2008
Results First Posted : September 29, 2014
Last Update Posted : August 13, 2015
Celgene Corporation
Information provided by (Responsible Party):
Kenneth Peters, MD, William Beaumont Hospitals

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.

Condition or disease Intervention/treatment Phase
Vulvodynia Drug: CC-10004 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Clinical Trial Of CC-10004 For The Treatment Of Vulvodynia
Study Start Date : December 2008
Actual Primary Completion Date : February 2011
Actual Study Completion Date : February 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Apremilast

Arm Intervention/treatment
Experimental: Study Drug CC 10004
Study drug CC-10004 20mg taken orally twice a day.
Drug: CC-10004
CC-10004 20 mg. twice a day for 12 weeks
Other Name: Study Drug

Primary Outcome Measures :
  1. Global Response Assessment [ Time Frame: 12 weeks ]

    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00814632

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United States, Michigan
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
Sponsors and Collaborators
Kenneth Peters, MD
Celgene Corporation
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Principal Investigator: Kenneth M Peters, M.D. Beaumont Hospitals

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Responsible Party: Kenneth Peters, MD, Principal Investigator, William Beaumont Hospitals Identifier: NCT00814632     History of Changes
Other Study ID Numbers: 2007-134
First Posted: December 25, 2008    Key Record Dates
Results First Posted: September 29, 2014
Last Update Posted: August 13, 2015
Last Verified: August 2015
Keywords provided by Kenneth Peters, MD, William Beaumont Hospitals:
pelvic pain
vulvar pain
Additional relevant MeSH terms:
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Vulvar Diseases
Genital Diseases, Female
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Immunosuppressive Agents
Immunologic Factors
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents