Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Treatment of Complex Regional Pain Syndrome With Once Daily Gastric-Retentive Gabapentin (Gralise)

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: NCT01623271
Recruitment Status : Terminated (Due to limited population of research participants.)
First Posted : June 19, 2012
Results First Posted : April 4, 2017
Last Update Posted : September 12, 2018
Sponsor:
Information provided by (Responsible Party):
Jianren Mao, MD, PhD, Massachusetts General Hospital

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Complex Regional Pain Syndrome I (CRPS I)
Intervention Drug: Gabapentin
Enrollment 5
Recruitment Details  
Pre-assignment Details  
Arm/Group Title CRPS I Pain Subjects
Hide Arm/Group Description

This is an open label study that involves taking Gralise pills (gastic-retentive gabapentin) for 8 weeks.

Day 1-15: Titration phase- titrate Gralise from 300 mg/day to 1800 mg/day Day 16-42: Maintenance phase- maintain the dose of 1800 mg/day Day 43-56: Taper phase- taper the Gralise from 100 mg/day to 300 mg/day

Period Title: Overall Study
Started 5
Completed 3
Not Completed 2
Reason Not Completed
Withdrawal by Subject             2
Arm/Group Title CRPS I Pain Subjects
Hide Arm/Group Description

This is an open label study that involves taking Gralise pills (gastic-retentive gabapentin) for 8 weeks.

Day 1-15: Titration phase- titrate Gralise from 300 mg/day to 1800 mg/day Day 16-42: Maintenance phase- maintain the dose of 1800 mg/day Day 43-56: Taper phase- taper the Gralise from 100 mg/day to 300 mg/day

Overall Number of Baseline Participants 5
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
<=18 years
0
   0.0%
Between 18 and 65 years
3
  60.0%
>=65 years
2
  40.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
Female
2
  40.0%
Male
3
  60.0%
Visual Analog Scale (VAS)   [1] 
Mean (Full Range)
Unit of measure:  Units on a scale
Number Analyzed 5 participants
5.8
(3 to 9)
[1]
Measure Description: Pain score on a scale of 0-10
1.Primary Outcome
Title Visual Analog Scale (VAS) at Visit 3
Hide Description Subjects rated their pain using the VAS at visit 3, which was the last day of their maintenance phase. After this visit, subjects begin to taper the gralise. The VAS 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 the 3 subjects who completed visit 3.
Time Frame At visit 3
Hide Outcome Measure Data
Hide Analysis Population Description
Only 3 subjects completed visit 3. The other 2 subjects dropped out due to expected side effects.
Arm/Group Title CRPS I Pain Subjects
Hide Arm/Group Description:

This is an open label study that involves taking Gralise pills (gastic-retentive gabapentin) for 8 weeks.

Day 1-15: Titration phase- titrate Gralise from 300 mg/day to 1800 mg/day Day 16-42: Maintenance phase- maintain the dose of 1800 mg/day Day 43-56: Taper phase- taper the Gralise from 100 mg/day to 300 mg/day

Overall Number of Participants Analyzed 3
Mean (Standard Deviation)
Unit of Measure: units on the VAS
3.67  (1.15)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CRPS I Pain Subjects
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title CRPS I Pain Subjects
Hide Arm/Group Description

This is an open label study that involves taking Gralise pills (gastic-retentive gabapentin) for 8 weeks.

Day 1-15: Titration phase- titrate Gralise from 300 mg/day to 1800 mg/day Day 16-42: Maintenance phase- maintain the dose of 1800 mg/day Day 43-56: Taper phase- taper the Gralise from 100 mg/day to 300 mg/day

All-Cause Mortality
CRPS I Pain Subjects
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
CRPS I Pain Subjects
Affected / at Risk (%) # Events
Total   0/5 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
CRPS I Pain Subjects
Affected / at Risk (%) # Events
Total   2/5 (40.00%)    
General disorders   
Expected Side Effects of Gralise * [1]  2/5 (40.00%)  2
*
Indicates events were collected by non-systematic assessment
[1]
- Headache, nausea, dizziness, fatigue, increased joint pain
Problems with recruitment and early termination of the study consequently resulted in uninterpretable data.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Jianren Mao, MD, PhD
Organization: Massachusetts General Hospital
Phone: 617-724-6102
Responsible Party: Jianren Mao, MD, PhD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01623271     History of Changes
Other Study ID Numbers: 2012P000466
First Submitted: June 12, 2012
First Posted: June 19, 2012
Results First Submitted: December 22, 2016
Results First Posted: April 4, 2017
Last Update Posted: September 12, 2018