ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 82 of 130 for:    Complex Regional Pain Syndrome

Effects of Pennsaid on Clinical Neuropathic Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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)

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Pennsaid Phase I, Placebo Phase II

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).

Placebo Phase I, Pennsaid Phase II

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).


Participant Flow for 3 periods

Period 1:   Phase I (2 Weeks)
    Pennsaid Phase I, Placebo Phase II   Placebo Phase I, Pennsaid Phase II
STARTED   18   17 
COMPLETED   16   14 
NOT COMPLETED   2   3 
Medication Exclusion                1                1 
Wrong Pain Type                1                0 
Positive Drug Screen                0                2 

Period 2:   Washout Period (1 Week)
    Pennsaid Phase I, Placebo Phase II   Placebo Phase I, Pennsaid Phase II
STARTED   16   14 
COMPLETED   16   14 
NOT COMPLETED   0   0 

Period 3:   Phase II (2 Weeks)
    Pennsaid Phase I, Placebo Phase II   Placebo Phase I, Pennsaid Phase II
STARTED   16   14 
COMPLETED   15   13 
NOT COMPLETED   1   1 
Skin Sensitivity                0                1 
Medication Exclusion                1                0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Pennsaid Phase I 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 Phase I 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 Total of all reporting groups

Baseline Measures
   Pennsaid Phase I   Placebo Phase I   Total 
Overall Participants Analyzed 
[Units: Participants]
 18   17   35 
Age 
[Units: Participants]
Count of 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 
[Units: Participants]
Count of Participants
     
Female      9  50.0%      8  47.1%      17  48.6% 
Male      9  50.0%      9  52.9%      18  51.4% 


  Outcome Measures

1.  Primary:   VAS After Treatment   [ Time Frame: 2 weeks. ]

2.  Secondary:   Clinical Neuropathic Pain Features- Burning After Treatment   [ Time Frame: 2 weeks ]

3.  Secondary:   Clinical Neuropathic Pain Features- Constant Pain and Hypersensitivity After Treatment   [ Time Frame: 2 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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
e-mail: mghpainresearch@partners.org



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