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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
Enrollment 10
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Study Drug CC 10004
Hide Arm/Group Description Study drug CC-10004 20mg taken orally twice a day for 12 weeks.
Period Title: Overall Study
Started 9 [1]
Completed 7 [2]
Not Completed 2
Reason Not Completed
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.
Arm/Group Title Study Drug CC 10004
Hide Arm/Group Description Study drug CC-10004 20mg taken orally twice a day for 12 weeks.
Overall Number of Baseline Participants 7
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants
<=18 years
0
   0.0%
Between 18 and 65 years
7
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants
Female
7
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 7 participants
7
1.Primary Outcome
Title Global Response Assessment
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Study Drug CC 10004
Hide Arm/Group Description:
Study drug CC-10004 20mg taken orally twice a day for 12 weeks.
Overall Number of Participants Analyzed 7
Measure Type: Number
Unit of Measure: participants
5
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Study Drug CC 10004
Hide Arm/Group Description Study drug CC-10004 20mg taken orally twice a day for 12 weeks.
All-Cause Mortality
Study Drug CC 10004
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Study Drug CC 10004
Affected / at Risk (%)
Total   0/9 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Study Drug CC 10004
Affected / at Risk (%)
Total   0/9 (0.00%) 
Small pilot study without placebo arm. Only 7 subjects completed treatment.
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
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