Trial Outcomes & Findings for Safety, Tolerability, and Efficacy of IA Verapamil in the Treatment of Joint Pain in Subjects With Osteoarthritis of the Knee (NCT NCT01645709)

Results Overview

To compare the efficacy of IA verapamil versus IA placebo for pain relief using the Western Ontario and McMaster Universities Arthritis Index (WOMAC) at week 4.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

81 participants

Primary outcome timeframe

4 weeks

Results posted on

2014-09-05

Participant Flow

Participant milestones

Participant milestones
Measure	Verapamil Subjects will be randomized to receive a single injection of IA Verapamil or IA Placebo at a ratio of 1:1. Verapamil	Placebo Subjects will be randomized to receive a single injection of IA Verapamil or IA Placebo at a ratio of 1:1. Placebo
Overall Study STARTED	0	0
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety, Tolerability, and Efficacy of IA Verapamil in the Treatment of Joint Pain in Subjects With Osteoarthritis of the Knee

Baseline characteristics by cohort

Baseline data not reported

PRIMARY outcome

Timeframe: 4 weeks

To compare the efficacy of IA verapamil versus IA placebo for pain relief using the Western Ontario and McMaster Universities Arthritis Index (WOMAC) at week 4.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 13 weeks

To compare the efficacy of IA verapamil and IA placebo using change from baseline in the following: • WOMAC total and subscale scores for pain, function, and stiffness at each visit

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 13 weeks

To compare the efficacy of IA verapamil and IA placebo using change from baseline in the following: • WOMAC pain subscale as measured from 2 to 12 weeks post-treatment using an AUC approach

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 13 weeks

To compare the efficacy of IA verapamil and IA placebo using change from baseline in the following: • In-clinic 24-hour recall pain intensity using the 0-10 numerical rating scale (NRS) at each visit

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 13 weeks

To compare the efficacy of IA verapamil and IA placebo using change from baseline in the following: • Difference in the current in-clinic pain intensity using the 0-10 NRS before and after exercise at each visit

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 13 weeks

To compare the efficacy of IA verapamil and IA placebo using change from baseline in the following: • Response rate

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 13 weeks

To compare the efficacy of IA verapamil and IA placebo using change from baseline in the following: • Patient Global Impression of Change (PGIC)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 13 weeks

To compare the efficacy of IA verapamil and IA placebo using change from baseline in the following: • Rescue medication use

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 13 weeks

Compare the safety of IA verapamil versus IA placebo using adverse events (AEs) as a comparator

Outcome measures

Outcome data not reported

Adverse Events

Verapamil

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

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

Stephen Snowdy, PhD

CaloSyn Pharma Inc.

Phone: 404-863-8892

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place