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Trial record 82 of 133 for:    Complex Regional Pain Syndrome

Effects of Pennsaid on Clinical Neuropathic Pain

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ClinicalTrials.gov Identifier: NCT01508676
Recruitment Status : Completed
First Posted : January 12, 2012
Results First Posted : February 6, 2017
Last Update Posted : February 6, 2017
Sponsor:
Information provided by (Responsible Party):
Jianren Mao, MD, PhD, Massachusetts General Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Conditions Neuralgia
Postherpetic Neuralgia
Reflex Sympathetic Dystrophy
Complex Regional Pain Syndrome (CRPS)
Interventions Drug: Pennsaid
Drug: Placebo (2.3% DMSO solution)
Enrollment 35

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Pennsaid Phase I, Placebo Phase II Placebo Phase I, Pennsaid Phase II
Hide Arm/Group Description

Phase I: 2 weeks applying Pennsaid lotion (20-40 drops; 2-4 times daily).

Washout: 1 week, applying nothing.

Phase II: 2 weeks applying Placebo lotion (20-40 drops; 2-4 times daily).

Phase I: 2 weeks applying Placebo lotion (20-40 drops; 2-4 times daily).

Washout: 1 week, applying nothing.

Phase II: 2 weeks applying Pennsaid lotion (20-40 drops; 2-4 times daily).

Period Title: Phase I (2 Weeks)
Started 18 17
Completed 16 14
Not Completed 2 3
Reason Not Completed
Medication Exclusion             1             1
Wrong Pain Type             1             0
Positive Drug Screen             0             2
Period Title: Washout Period (1 Week)
Started 16 14
Completed 16 14
Not Completed 0 0
Period Title: Phase II (2 Weeks)
Started 16 14
Completed 15 13
Not Completed 1 1
Reason Not Completed
Skin Sensitivity             0             1
Medication Exclusion             1             0
Arm/Group Title Pennsaid Phase I Placebo Phase I Total
Hide Arm/Group Description Pennsaid (20-40 drops; 2-4 times daily). Upon completion of the first phase, subjects in each arm will be crossed over (i.e., from placebo to Pennsaid and vise versa). Pennsaid or placebo lotion will be packed in a container with identical appearance before being dispensed to study subjects. Placebo lotion (20-40 drops; 2-4 times daily). Upon completion of the first phase, subjects in each arm will be crossed over (i.e., from placebo to Pennsaid and vise versa). Pennsaid or placebo lotion will be packed in a container with identical appearance before being dispensed to study subjects. Total of all reporting groups
Overall Number of Baseline Participants 18 17 35
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 17 participants 35 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
17
  94.4%
15
  88.2%
32
  91.4%
>=65 years
1
   5.6%
2
  11.8%
3
   8.6%
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 17 participants 35 participants
Female
9
  50.0%
8
  47.1%
17
  48.6%
Male
9
  50.0%
9
  52.9%
18
  51.4%
1.Primary Outcome
Title VAS After Treatment
Hide Description

Subjects rated their pain using the Visual Analog Scale after a 2 week phase of using pennsaid lotion and after a 2 week phase of using placebo lotion.

The Visual Analog Scale is subject reported on a scale of 0-10 with 0 being no pain, and 10 being the worst pain they can imagine. Results reported are an average of reported VAS scores for the 28 subjects who completed both phase I and phase II of the study.

Time Frame 2 weeks.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Only subjects who completed both phases of the crossover study were considered for data analysis.
Arm/Group Title Pennsaid Placebo
Hide Arm/Group Description:
All subjects who recieved Pennsaid lotion in either Phase I or II were considered.
All subjects who recieved Pennsaid lotion in either Phase I or II were considered.
Overall Number of Participants Analyzed 28 28
Mean (Standard Deviation)
Unit of Measure: Visual Analog Scale
4.9  (1.9) 5.6  (2.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pennsaid, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .04
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
2.Secondary Outcome
Title Clinical Neuropathic Pain Features- Burning After Treatment
Hide Description

Subjects rated their "burning pain" using the Visual Analog Scale after a 2 week phase of using pennsaid lotion and after a 2 week phase of using placebo lotion.

The Visual Analog Scale is subject reported on a scale of 0-10 with 0 being no pain, and 10 being the worst pain they can imagine. Results reported are an average of reported VAS scores for the 28 subjects who completed both phase I and phase II of the study.

Time Frame 2 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Only subjects
Arm/Group Title Pennsaid Placebo
Hide Arm/Group Description:
All subjects who recieved Pennsaid lotion in either Phase I or II were considered.
All subjects who recieved Placebo lotion in either Phase I or II were considered.
Overall Number of Participants Analyzed 28 28
Mean (Standard Deviation)
Unit of Measure: Visual Analog Scale
2.9  (2.6) 4.3  (2.8)
3.Secondary Outcome
Title Clinical Neuropathic Pain Features- Constant Pain and Hypersensitivity After Treatment
Hide Description

Subjects rated their "constant pain" and "hypersensitivity" using the Visual Analog Scale after a 2 week phase of using pennsaid lotion and after a 2 week phase of using placebo lotion.

The Visual Analog Scale is subject reported on a scale of 0-10 with 0 being no pain, and 10 being the worst pain they can imagine. Results reported are an average of reported VAS scores for the 28 subjects who completed both phase I and phase II of the study.

Time Frame 2 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pennsaid Placebo
Hide Arm/Group Description:
All subjects who recieved Pennsaid lotion in either Phase I or II were considered.
All subjects who recieved Placebo lotion in either Phase I or II were considered.
Overall Number of Participants Analyzed 28 28
Mean (Standard Deviation)
Unit of Measure: Visual Analog Scale
4.0  (2.9) 4.3  (2.8)
Time Frame Adverse event data was collected over the length of a subject's participation in the study (5 weeks).
Adverse Event Reporting Description Due to the study design, subjects who withdrew before completing the entire study were not considered for any treatment period that they did not participate in due to drop out or withdrawl. Subjects who completed only part of a treatment period were considered.These numbers may differ from the total number enrolled in the study for this reason.
 
Arm/Group Title Pennsaid Placebo
Hide Arm/Group Description Pennsaid (20-40 drops; 2-4 times daily for 2 weeks). Placebo lotion (20-40 drops; 2-4 times daily for 2 weeks).
All-Cause Mortality
Pennsaid Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Pennsaid Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/32 (0.00%)   0/33 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Pennsaid Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/32 (0.00%)   0/33 (0.00%) 
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: Dr. Jianren Mao
Organization: Massachusetts General Hospital
Phone: 6177246102
Responsible Party: Jianren Mao, MD, PhD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01508676     History of Changes
Other Study ID Numbers: 2011p000897
First Submitted: January 4, 2012
First Posted: January 12, 2012
Results First Submitted: September 23, 2016
Results First Posted: February 6, 2017
Last Update Posted: February 6, 2017