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CC-10004 For The Treatment Of Vulvodynia

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ClinicalTrials.gov Identifier: NCT00814632
Recruitment Status : Completed
First Posted : December 25, 2008
Results First Posted : September 29, 2014
Last Update Posted : August 13, 2015
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
Kenneth Peters, MD, William Beaumont Hospitals

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Vulvodynia
Intervention: Drug: CC-10004

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Study Drug CC 10004 Study drug CC-10004 20mg taken orally twice a day for 12 weeks.

Participant Flow:   Overall Study
    Study Drug CC 10004
STARTED   9 [1] 
COMPLETED   7 [2] 
NOT COMPLETED   2 
Lack of Efficacy                2 
[1] Ten were allocated to treatment intervention however one was not treated due to lactose allergy.
[2] Two subjects withdrew early due to lack of efficacy.



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Study Drug CC 10004 Study drug CC-10004 20mg taken orally twice a day for 12 weeks.

Baseline Measures
   Study Drug CC 10004 
Overall Participants Analyzed 
[Units: Participants]
 7 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   7 
>=65 years   0 
Gender 
[Units: Participants]
 
Female   7 
Male   0 
Region of Enrollment 
[Units: Participants]
 
United States   7 


  Outcome Measures

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


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Small pilot study without placebo arm. Only 7 subjects completed treatment.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Kenneth M. Peters, MD
Organization: William Beaumont Hospital
phone: 248-551-0387
e-mail: kmpeters@beaumont.edu



Responsible Party: Kenneth Peters, MD, William Beaumont Hospitals
ClinicalTrials.gov Identifier: NCT00814632     History of Changes
Other Study ID Numbers: 2007-134
First Submitted: December 23, 2008
First Posted: December 25, 2008
Results First Submitted: December 24, 2013
Results First Posted: September 29, 2014
Last Update Posted: August 13, 2015