Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 38 of 424 for:    Pregabalin

Pregabalin in CIPN

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: NCT02394951
Recruitment Status : Completed
First Posted : March 20, 2015
Results First Posted : May 14, 2019
Last Update Posted : May 14, 2019
Sponsor:
Information provided by (Responsible Party):
simon.haroutounian, Washington University School of Medicine

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Other
Conditions Neuropathy
Pain
Interventions Drug: Pregabalin
Drug: Placebo
Enrollment 26
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Pregabalin First Then Placebo Placebo First Then Pregabalin
Hide Arm/Group Description

Pregabalin administered for 4 weeks, titrated to highest tolerated dose up to 600 mg/day.

Pregabalin: Anticonvulsant

Placebo: Identical, matching inactive substance

Identical, matching inactive substance administered for 4 weeks following the same dosing regimen.

Pregabalin: Anticonvulsant

Placebo: Identical, matching inactive substance

Period Title: Period I
Started 12 14
Completed 11 13
Not Completed 1 1
Period Title: Period II
Started 11 13
Completed 11 9
Not Completed 0 4
Arm/Group Title Pregabalin First Then Placebo Placebo First Then Pregabalin Total
Hide Arm/Group Description

Pregabalin administered for 4 weeks, titrated to highest tolerated dose up to 600 mg/day.

Pregabalin: Anticonvulsant

Placebo: Identical, matching inactive substance

Identical, matching inactive substance administered for 4 weeks following the same dosing regimen.

Pregabalin: Anticonvulsant

Placebo: Identical, matching inactive substance

Total of all reporting groups
Overall Number of Baseline Participants 12 14 26
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants 14 participants 26 participants
65.1  (8.2) 59.9  (11.4) 62.3  (10.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 14 participants 26 participants
Female
5
  41.7%
3
  21.4%
8
  30.8%
Male
7
  58.3%
11
  78.6%
18
  69.2%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 14 participants 26 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
  16.7%
0
   0.0%
2
   7.7%
White
10
  83.3%
14
 100.0%
24
  92.3%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 12 participants 14 participants 26 participants
12 14 26
1.Primary Outcome
Title Change in Spontaneous Pain Intensity as a Function of Baseline MPT
Hide Description Correlation between Mechanical Pain Threshold (MPT in mN) at baseline and reduction in spontaneous pain intensity (% reduction on 0-10 NRS) at the end of 4-week treatment. The slopes (Pearson coefficients) of the correlation obtained from pregabalin vs. placebo will be compared.
Time Frame Baseline to week 4
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description:

Pregabalin administered for 4 weeks, titrated to highest tolerated dose up to 600 mg/day.

Pregabalin: Anticonvulsant

Placebo: Identical, matching inactive substance

Identical, matching inactive substance administered for 4 weeks following the same dosing regimen.

Pregabalin: Anticonvulsant

Placebo: Identical, matching inactive substance

Overall Number of Participants Analyzed 23 23
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Pearson correlation coefficient
-0.0179
(-0.0459 to 0.0101)
-0.0172
(-0.0514 to 0.0170)
2.Secondary Outcome
Title Absolute Change in Pain Intensity, Measured on 0-10 Numerical Rating Scale (NRS)
Hide Description Absolute change in pain intensity on 0-10 numerical rating scale (NRS) from baseline to 4 weeks with pregabalin vs. placebo NRS: 0= no pain, 10= worst pain
Time Frame Baseline to week 4
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description:

Pregabalin administered for 4 weeks, titrated to highest tolerated dose up to 600 mg/day.

Pregabalin: Anticonvulsant

Placebo: Identical, matching inactive substance

Identical, matching inactive substance administered for 4 weeks following the same dosing regimen.

Pregabalin: Anticonvulsant

Placebo: Identical, matching inactive substance

Overall Number of Participants Analyzed 24 24
Mean (Standard Deviation)
Unit of Measure: units on a scale (0-10 NRS)
-1.0  (1.13) 0.3  (1.10)
3.Secondary Outcome
Title Change in NPSI Outcomes
Hide Description Change from baseline to week 4 in total NPSI (Neuropathic Pain Symptom Inventory) score The total NPSI score is comprised by adding 5 sub-scores (Burning pain, Pressing pain, Paroxysmal pain, Evoked pain, and Paresthesia/Dysesthesia) and is expressed on a 0-100 scale; 0-minimum (least), and 100 maximum (worst) score
Time Frame Baseline to week 4
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description:

Pregabalin administered for 4 weeks, titrated to highest tolerated dose up to 600 mg/day.

Pregabalin: Anticonvulsant

Placebo: Identical, matching inactive substance

Identical, matching inactive substance administered for 4 weeks following the same dosing regimen.

Pregabalin: Anticonvulsant

Placebo: Identical, matching inactive substance

Overall Number of Participants Analyzed 24 24
Mean (Standard Deviation)
Unit of Measure: units on a scale (0-100 NPSI score)
-9.8  (12.49) 1.8  (20.93)
4.Secondary Outcome
Title Change in BPI Outcomes (SEVERITY)
Hide Description Change from baseline to week 4 in BPI (Brief Pain Inventory) pain severity severity score BPI severity score is expressed on 0-10 scale, with 0 being the minimum (least), and 10 being the maximum (worst) pain severity
Time Frame Baseline to week 4
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description:

Pregabalin administered for 4 weeks, titrated to highest tolerated dose up to 600 mg/day.

Pregabalin: Anticonvulsant

Placebo: Identical, matching inactive substance

Identical, matching inactive substance administered for 4 weeks following the same dosing regimen.

Pregabalin: Anticonvulsant

Placebo: Identical, matching inactive substance

Overall Number of Participants Analyzed 24 24
Mean (Standard Deviation)
Unit of Measure: units on a scale (0-10 BPI severity)
-0.8  (1.52) -0.1  (1.14)
5.Secondary Outcome
Title Change in Sleep Problem Index (SPI) Outcomes
Hide Description Change from baseline to week 4 in SPI (Sleep Problem Index) score, on 0-100 scale, where 0= best (least) score, and 100= maximum (worst) score
Time Frame Baseline to week 4
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description:

Pregabalin administered for 4 weeks, titrated to highest tolerated dose up to 600 mg/day.

Pregabalin: Anticonvulsant

Placebo: Identical, matching inactive substance

Identical, matching inactive substance administered for 4 weeks following the same dosing regimen.

Pregabalin: Anticonvulsant

Placebo: Identical, matching inactive substance

Overall Number of Participants Analyzed 24 24
Mean (Standard Deviation)
Unit of Measure: units on a scale (0-100 SPI)
-5.1  (9.45) -4.1  (11.64)
6.Secondary Outcome
Title Change in BPI Outcomes (INTERFERENCE)
Hide Description Change from baseline to week 4 in BPI (Brief Pain Inventory) pain interference score BPI interference score is expressed on 0-10 scale, with 0 being the minimum (least), and 10 being the maximum (worst) pain interference
Time Frame baseline to week 4
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description:

Pregabalin administered for 4 weeks, titrated to highest tolerated dose up to 600 mg/day.

Pregabalin: Anticonvulsant

Placebo: Identical, matching inactive substance

Identical, matching inactive substance administered for 4 weeks following the same dosing regimen.

Pregabalin: Anticonvulsant

Placebo: Identical, matching inactive substance

Overall Number of Participants Analyzed 24 24
Mean (Standard Deviation)
Unit of Measure: units on a scale (0-10 BPI interference)
-0.6  (1.64) -0.2  (1.10)
7.Secondary Outcome
Title Number of Patients With Significant Pain Reduction
Hide Description Number of patients who experienced 50% or more reduction in average daily pain (on 0-10 NRS, Numerical Rating Scale, where 0=least pain, 10=worst pain)
Time Frame Baseline to week 4
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description:

Pregabalin administered for 4 weeks, titrated to highest tolerated dose up to 600 mg/day.

Pregabalin: Anticonvulsant

Placebo: Identical, matching inactive substance

Identical, matching inactive substance administered for 4 weeks following the same dosing regimen.

Pregabalin: Anticonvulsant

Placebo: Identical, matching inactive substance

Overall Number of Participants Analyzed 24 24
Measure Type: Count of Participants
Unit of Measure: Participants
5
  20.8%
3
  12.5%
Time Frame 11 weeks
Adverse Event Reporting Description Common Terminology Criteria for Adverse Events – CTCAE version 4.0
 
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description

Pregabalin administered for 4 weeks, titrated to highest tolerated dose up to 600 mg/day.

Pregabalin: Anticonvulsant

Placebo: Identical, matching inactive substance

Identical, matching inactive substance administered for 4 weeks following the same dosing regimen.

Pregabalin: Anticonvulsant

Placebo: Identical, matching inactive substance

All-Cause Mortality
Pregabalin Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)      0/25 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Pregabalin Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/25 (4.00%)      0/25 (0.00%)    
Gastrointestinal disorders     
Small bowel obstruction * [1]  1/25 (4.00%)  1 0/25 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
[1]
Small bowel obstruction in the setting of a new oncological diagnosis
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Pregabalin Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   23/25 (92.00%)      21/25 (84.00%)    
Eye disorders     
Blurred Vision  1  8/25 (32.00%)  4/25 (16.00%) 
Gastrointestinal disorders     
Dry Mouth  2  14/25 (56.00%)  10/25 (40.00%) 
Nausea  1  6/25 (24.00%)  7/25 (28.00%) 
General disorders     
Edema  1  8/25 (32.00%)  8/25 (32.00%) 
Gait Disturbance * 1  2/25 (8.00%)  0/25 (0.00%) 
Investigations     
Weight Gain * 1  4/25 (16.00%)  1/25 (4.00%) 
Nervous system disorders     
Dizziness  1  17/25 (68.00%)  4/25 (16.00%) 
Somnolence  1  22/25 (88.00%)  11/25 (44.00%) 
Headache  1  10/25 (40.00%)  11/25 (44.00%) 
Spasticity * 1  3/25 (12.00%)  0/25 (0.00%) 
Skin and subcutaneous tissue disorders     
Rash maculo-papular * 1  2/25 (8.00%)  1/25 (4.00%) 
1
Term from vocabulary, CTCAE (4.0)
2
Term from vocabulary, CTCAE 4.0
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
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. Simon Haroutounian
Organization: Washington University in Saint Louis
Phone: 3143622628
Responsible Party: simon.haroutounian, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT02394951     History of Changes
Other Study ID Numbers: 201501067
First Submitted: March 4, 2015
First Posted: March 20, 2015
Results First Submitted: April 1, 2019
Results First Posted: May 14, 2019
Last Update Posted: May 14, 2019