Trial Outcomes & Findings for CC-10004 For The Treatment Of Vulvodynia (NCT NCT00814632)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

10 participants

Primary outcome timeframe

12 weeks

Results posted on

2015-08-13

Participant Flow

Participant milestones

Participant milestones
Measure	Study Drug CC 10004 Study drug CC-10004 20mg taken orally twice a day for 12 weeks.
Overall Study STARTED	9
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Study Drug CC 10004 Study drug CC-10004 20mg taken orally twice a day for 12 weeks.
Overall Study Lack of Efficacy	2

Baseline Characteristics

CC-10004 For The Treatment Of Vulvodynia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Study Drug CC 10004 n=7 Participants Study drug CC-10004 20mg taken orally twice a day for 12 weeks.
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=99 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants
Sex: Female, Male Female	7 Participants n=99 Participants
Sex: Female, Male Male	0 Participants n=99 Participants
Region of Enrollment United States	7 participants n=99 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Study Drug CC 10004 n=7 Participants Study drug CC-10004 20mg taken orally twice a day for 12 weeks.
Global Response Assessment	5 participants

Adverse Events

Study Drug CC 10004

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Kenneth M. Peters, MD

William Beaumont Hospital

Phone: 248-551-0387

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place