Trial Outcomes & Findings for Treating Urological Chronic Pelvic Pain Syndrome (UCPPS) Pain (NCT NCT02385266)

NCT ID: NCT02385266

Last Updated: 2023-05-17

Results Overview

The visual analog scale (VAS) is a measurement tool used to assess the level of pain experienced by a patient. The scale is a 100 mm horizontal line, with one end representing "no pain" and the other end representing "worst pain imaginable." The patient is asked to mark on the line the point that best represents their level of pain. The minimum score is 0 mm, indicating no pain, while the maximum score is 100 mm, indicating the worst pain imaginable. Higher scores on the VAS indicate a worse outcome, while lower scores indicate a better outcome. The VAS score can be determined by measuring the distance in millimeters from the left end of the line to the point marked by the patient. The range of scores can be used to interpret the level of pain experienced by the patient, with higher scores indicating greater pain severity.

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 24 participants
• Primary outcome timeframe: 18 weeks after baseline visit
• Results posted on: 2023-05-17

Participant Flow

Participant milestones

Measure	D-Cycloserine and Acetominophen D-cycloserine 200mg/bid and Acetaminophen prn D-Cycloserine: Pharmaceutical intervention aimed at altering central nervous system function takes place over 4.5 months with daily use of d-Cycloserine.	Placebo and Acetominophen Placebo capsules (lactose)/bid and Acetaminophen prn Placebo (for D-cycloserine): Lactose filled capsules to mimic DCS 200mg capsules
Overall Study STARTED	12	12
Overall Study COMPLETED	11	9
Overall Study NOT COMPLETED	1	3

Reasons for withdrawal

Measure	D-Cycloserine and Acetominophen D-cycloserine 200mg/bid and Acetaminophen prn D-Cycloserine: Pharmaceutical intervention aimed at altering central nervous system function takes place over 4.5 months with daily use of d-Cycloserine.	Placebo and Acetominophen Placebo capsules (lactose)/bid and Acetaminophen prn Placebo (for D-cycloserine): Lactose filled capsules to mimic DCS 200mg capsules
Overall Study Withdrawal by Subject	1	3

Baseline Characteristics

Treating Urological Chronic Pelvic Pain Syndrome (UCPPS) Pain

Baseline characteristics by cohort

Measure	D-Cycloserine and Acetominophen n=12 Participants D-cycloserine 200mg/bid and Acetaminophen prn D-Cycloserine: Pharmaceutical intervention aimed at altering central nervous system function takes place over 4.5 months with daily use of d-Cycloserine.	Placebo and Acetominophen n=12 Participants Placebo capsules (lactose)/bid and Acetaminophen prn Placebo (for D-cycloserine): Lactose filled capsules to mimic DCS 200mg capsules	Total n=24 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=5 Participants	12 Participants n=7 Participants	24 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	44.7 years STANDARD_DEVIATION 14.8 • n=5 Participants	39.7 years STANDARD_DEVIATION 10.3 • n=7 Participants	43.4 years STANDARD_DEVIATION 12.1 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	12 Participants n=7 Participants	24 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants	12 participants n=7 Participants	24 participants n=5 Participants

PRIMARY outcome

Timeframe: 18 weeks after baseline visit

The visual analog scale (VAS) is a measurement tool used to assess the level of pain experienced by a patient. The scale is a 100 mm horizontal line, with one end representing "no pain" and the other end representing "worst pain imaginable." The patient is asked to mark on the line the point that best represents their level of pain.

The minimum score is 0 mm, indicating no pain, while the maximum score is 100 mm, indicating the worst pain imaginable. Higher scores on the VAS indicate a worse outcome, while lower scores indicate a better outcome.

The VAS score can be determined by measuring the distance in millimeters from the left end of the line to the point marked by the patient. The range of scores can be used to interpret the level of pain experienced by the patient, with higher scores indicating greater pain severity.

Outcome measures

Measure	D-Cycloserine and Acetominophen n=11 Participants D-cycloserine 200mg/bid and Acetaminophen prn D-Cycloserine: Pharmaceutical intervention aimed at altering central nervous system function takes place over 4.5 months with daily use of d-Cycloserine.	Placebo and Acetominophen n=9 Participants Placebo capsules (lactose)/bid and Acetaminophen prn Placebo (for D-cycloserine): Lactose filled capsules to mimic DCS 200mg capsules
Visual Analog Scale (VAS)	3.2 units on a scale Standard Deviation 2.6	3.0 units on a scale Standard Deviation 1.5

Adverse Events

D-Cycloserine and Acetominophen

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo and Acetominophen

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

Camila Bonin Pinto, PhD

Northwestern University

Phone: 3125033971

Email: camila.pinto@northwestern.edu

Results disclosure agreements

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