Trial Outcomes & Findings for An Open-Label Study of CC-10004 for Chronic Prostatitis/Chronic Pelvic Pain Syndrome (NCT NCT00701311)

NCT ID: NCT00701311

Last Updated: 2014-10-06

Results Overview

The primary efficacy measure was a Global Response Assessment (GRA), a subject completed questionnaire that measures improvement in overall symptoms on a 7-point scale: 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: 21 participants
• Primary outcome timeframe: 12 weeks
• Results posted on: 2014-10-06

Participant Flow

Recruitment took place over approximately one year from the offices of private urologists.

A total of 21 male subjects meeting inclusion criteria were recruited. Of these, two failed screening and two were enrolled but did not start drug. Therefore 17 subjects started treatment drug.

Participant milestones

Measure	CC-10004 CC-10004 administered 20mg po twice daily for up to 12 weeks.
Overall Study STARTED	17
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Measure	CC-10004 CC-10004 administered 20mg po twice daily for up to 12 weeks.
Overall Study Lack of Efficacy	3
Overall Study Adverse Event	3
Overall Study Withdrawal by Subject	2

Baseline Characteristics

An Open-Label Study of CC-10004 for Chronic Prostatitis/Chronic Pelvic Pain Syndrome

Baseline characteristics by cohort

Measure	CC-10004 n=17 Participants CC-10004 administered 20mg po twice daily for up to 12 weeks.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	17 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	48.2 years STANDARD_DEVIATION 10 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants
Region of Enrollment United States	17 participants n=5 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 on a 7-point scale: 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

Measure	CC-10004 n=17 Participants CC-10004 administered 20mg po twice daily for up to 12 weeks.
Global Response Assessment	2 participants

Adverse Events

Treatment Arm

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Treatment Arm n=17 participants at risk Open label, one arm study.
Gastrointestinal disorders Nausea	17.6% 3/17
Gastrointestinal disorders Diarrhea	11.8% 2/17
Nervous system disorders Headache	11.8% 2/17
Nervous system disorders Dizziness	11.8% 2/17
Vascular disorders Facial Flushing	5.9% 1/17
Skin and subcutaneous tissue disorders Lower extremity ulcer	5.9% 1/17
Skin and subcutaneous tissue disorders Mouth Ulcer	5.9% 1/17

Additional Information

Kenneth M. Peters, MD

William Beaumont Hospital

Phone: 248-551-0387

Email: kmpeters@beaumont.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place