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Trial record 90 of 22163 for:    Placebo AND subjects

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

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ClinicalTrials.gov Identifier: NCT01645709
Recruitment Status : Terminated (Sponsor decision to terminate study)
First Posted : July 20, 2012
Results First Posted : September 5, 2014
Last Update Posted : September 5, 2014
Sponsor:
Collaborator:
Health Decisions
Information provided by (Responsible Party):
Calosyn Pharma, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Osteoarthritis of the Knee
Interventions Drug: Verapamil
Drug: Placebo
Enrollment 81
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Verapamil Placebo
Hide Arm/Group Description

Subjects will be randomized to receive a single injection of IA Verapamil or IA Placebo at a ratio of 1:1.

Verapamil

Subjects will be randomized to receive a single injection of IA Verapamil or IA Placebo at a ratio of 1:1.

Placebo

Period Title: Overall Study
Started 0 [1] 0 [1]
Completed 0 [1] 0 [1]
Not Completed 0 0
[1]
Study was terminated; not made unblind
Arm/Group Title Verapamil Placebo Total
Hide Arm/Group Description

Subjects will be randomized to receive a single injection of IA Verapamil or IA Placebo at a ratio of 1:1.

Verapamil

Subjects will be randomized to receive a single injection of IA Verapamil or IA Placebo at a ratio of 1:1.

Placebo

Total of all reporting groups
Overall Number of Baseline Participants 0 0 0
Hide Baseline Analysis Population Description
Study was terminated and no data is available
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
Female
Male
1.Primary Outcome
Title Compare Efficacy of Verapmil vs Placebo at Week 4
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Verapamil Placebo
Hide Arm/Group Description:

Subjects will be randomized to receive a single injection of IA Verapamil or IA Placebo at a ratio of 1:1.

Verapamil

Subjects will be randomized to receive a single injection of IA Verapamil or IA Placebo at a ratio of 1:1.

Placebo

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Compare Efficacy of Verapamil to Placebo Compared to Baseline
Hide Description

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

Time Frame 13 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Verapamil Placebo
Hide Arm/Group Description:

Subjects will be randomized to receive a single injection of IA Verapamil or IA Placebo at a ratio of 1:1.

Verapamil

Subjects will be randomized to receive a single injection of IA Verapamil or IA Placebo at a ratio of 1:1.

Placebo

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Compare Efficacy of Verapamil to Placebo Compared to Baseline
Hide Description

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

Time Frame 13 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Verapamil Placebo
Hide Arm/Group Description:

Subjects will be randomized to receive a single injection of IA Verapamil or IA Placebo at a ratio of 1:1.

Verapamil

Subjects will be randomized to receive a single injection of IA Verapamil or IA Placebo at a ratio of 1:1.

Placebo

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Compare Efficacy of Verapamil to Placebo Compared to Baseline
Hide Description

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

Time Frame 13 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Verapamil Placebo
Hide Arm/Group Description:

Subjects will be randomized to receive a single injection of IA Verapamil or IA Placebo at a ratio of 1:1.

Verapamil

Subjects will be randomized to receive a single injection of IA Verapamil or IA Placebo at a ratio of 1:1.

Placebo

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Compare Efficacy of Verapamil to Placebo Compared to Baseline
Hide Description

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

Time Frame 13 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Verapamil Placebo
Hide Arm/Group Description:

Subjects will be randomized to receive a single injection of IA Verapamil or IA Placebo at a ratio of 1:1.

Verapamil

Subjects will be randomized to receive a single injection of IA Verapamil or IA Placebo at a ratio of 1:1.

Placebo

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Compare Efficacy of Verapamil to Placebo Compared to Baseline
Hide Description

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

• Response rate

Time Frame 13 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Verapamil Placebo
Hide Arm/Group Description:

Subjects will be randomized to receive a single injection of IA Verapamil or IA Placebo at a ratio of 1:1.

Verapamil

Subjects will be randomized to receive a single injection of IA Verapamil or IA Placebo at a ratio of 1:1.

Placebo

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Compare Efficacy of Verapamil to Placebo Compared to Baseline
Hide Description

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

• Patient Global Impression of Change (PGIC)

Time Frame 13 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Verapamil Placebo
Hide Arm/Group Description:

Subjects will be randomized to receive a single injection of IA Verapamil or IA Placebo at a ratio of 1:1.

Verapamil

Subjects will be randomized to receive a single injection of IA Verapamil or IA Placebo at a ratio of 1:1.

Placebo

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
8.Secondary Outcome
Title Compare Efficacy of Verapamil to Placebo Compared to Baseline
Hide Description

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

• Rescue medication use

Time Frame 13 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Verapamil Placebo
Hide Arm/Group Description:

Subjects will be randomized to receive a single injection of IA Verapamil or IA Placebo at a ratio of 1:1.

Verapamil

Subjects will be randomized to receive a single injection of IA Verapamil or IA Placebo at a ratio of 1:1.

Placebo

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
9.Secondary Outcome
Title Number of Subjects With Adverse Events
Hide Description Compare the safety of IA verapamil versus IA placebo using adverse events (AEs) as a comparator
Time Frame 13 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Verapamil Placebo
Hide Arm/Group Description:

Subjects will be randomized to receive a single injection of IA Verapamil or IA Placebo at a ratio of 1:1.

Verapamil

Subjects will be randomized to receive a single injection of IA Verapamil or IA Placebo at a ratio of 1:1.

Placebo

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Verapamil Placebo
Hide Arm/Group Description

Subjects will be randomized to receive a single injection of IA Verapamil or IA Placebo at a ratio of 1:1.

Verapamil

Subjects will be randomized to receive a single injection of IA Verapamil or IA Placebo at a ratio of 1:1.

Placebo

All-Cause Mortality
Verapamil Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Verapamil Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Verapamil Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Stephen Snowdy, PhD
Organization: CaloSyn Pharma Inc.
Phone: 404-863-8892
Responsible Party: Calosyn Pharma, Inc.
ClinicalTrials.gov Identifier: NCT01645709     History of Changes
Other Study ID Numbers: CS-201
First Submitted: July 17, 2012
First Posted: July 20, 2012
Results First Submitted: August 26, 2014
Results First Posted: September 5, 2014
Last Update Posted: September 5, 2014