CC-10004 For The Treatment Of Vulvodynia

NCT00814632 | Completed Phase 2 Results DMC

• 1 other identifier: 2007-134
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Vulvodynia

Keywords

vulvodynia; pelvic pain; vulvar pain

Outcome Measures

Primary Outcomes (1)

• 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.

  12 weeks

Study Arms (1)

Study Drug CC 10004

EXPERIMENTAL

Study drug CC-10004 20mg taken orally twice a day.

Drug: CC-10004

Interventions

CC-10004 DRUG

CC-10004 20 mg. twice a day for 12 weeks

Also known as: Study Drug

Study Drug CC 10004

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kenneth Peters, MD: lead
• Celgene Corporation: collaborator

Study Sites (1)

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

MeSH Terms

Conditions

Vulvodynia; Pelvic Pain

Interventions

apremilast; Drug Evaluation

Condition Hierarchy (Ancestors)

Vulvar Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drug Development; Investigative Techniques; Evaluation Studies as Topic

Limitations and Caveats

Small pilot study without placebo arm. Only 7 subjects completed treatment.

Results Point of Contact

• Title: Kenneth M. Peters, MD
• Organization: William Beaumont Hospital

kmpeters@beaumont.edu

248-551-0387

Study Officials

• Kenneth M Peters, M.D.

  Beaumont Hospitals

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 23, 2008
• First Posted: December 25, 2008
• Study Start: December 1, 2008
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: August 13, 2015
• Results First Posted: September 29, 2014

Record last verified: 2015-08

Locations

US (1)