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Pregabalin and Colonic Function

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ClinicalTrials.gov Identifier: NCT01094808
Recruitment Status : Completed
First Posted : March 29, 2010
Results First Posted : March 6, 2012
Last Update Posted : March 7, 2012
Sponsor:
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Center for Research Resources (NCRR)
Information provided by:
Mayo Clinic

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Condition Healthy
Interventions Drug: Pregabalin
Drug: Placebo
Other: Bowel preparation
Enrollment 62
Recruitment Details The study was conducted between April 2010 and January 2011 at the Mayo Clinic, Rochester, Minnesota.
Pre-assignment Details  
Arm/Group Title Pregabalin 75 mg Pregabalin 200 mg Placebo
Hide Arm/Group Description Subjects randomized to this arm received a single dose of pregabalin 75 mg orally Subjects randomized to this arm received a single dose of pregabalin 200 mg orally Subjects randomized to this arm received a single dose of placebo medication orally
Period Title: Overall Study
Started 21 20 21
Completed 20 19 21
Not Completed 1 1 0
Reason Not Completed
Withdrawal by Subject             1             1             0
Arm/Group Title Pregabalin 75 mg Pregabalin 200 mg Placebo Total
Hide Arm/Group Description Subjects randomized to this arm received a single dose of pregabalin 75 mg orally Subjects randomized to this arm received a single dose of pregabalin 200 mg orally Subjects randomized to this arm received a single dose of placebo medication orally Total of all reporting groups
Overall Number of Baseline Participants 21 20 21 62
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 21 participants 20 participants 21 participants 62 participants
32.2  (11.9) 32.4  (9.1) 31.6  (11.8) 32  (11)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 20 participants 21 participants 62 participants
Female
16
  76.2%
15
  75.0%
15
  71.4%
46
  74.2%
Male
5
  23.8%
5
  25.0%
6
  28.6%
16
  25.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 21 participants 20 participants 21 participants 62 participants
21 20 21 62
Body Mass Index (BMI)   [1] 
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 21 participants 20 participants 21 participants 62 participants
25.8  (3.7) 26.7  (6.3) 26.4  (4.4) 26.3  (0.6)
[1]
Measure Description: Body mass index is defined as the individual's body weight divided by the square of his or her height.
1.Primary Outcome
Title Sensory Threshold for Pain
Hide Description The sensory threshold for first perception of pain was measured by stepwise inflation of the balloon in increments of 4 mm Hg at 60 second intervals. The balloon was placed in the mid-descending or junction of the sigmoid and descending colon. During this assessment participants were asked to report when they had the first perception of pain. The investigator recorded the threshold pressure at which the participants reported this sensation.
Time Frame approximately 60 minutes after drug administration
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pregabalin 75 mg Pregabalin 200 mg Placebo
Hide Arm/Group Description:
Subjects randomized to this arm received a single dose of pregabalin 75 mg orally
Subjects randomized to this arm received a single dose of pregabalin 200 mg orally
Subjects randomized to this arm received a single dose of placebo medication orally
Overall Number of Participants Analyzed 20 19 21
Mean (Standard Deviation)
Unit of Measure: mm Hg
45.8  (14.9) 46.7  (13.9) 45.0  (14.0)
2.Primary Outcome
Title Sensation Ratings for Pain and Gas at 30 mm Hg Distension Above Baseline Operating Pressure
Hide Description The 30 mm Hg distension refers to inflation of the balloon placed in placed in the mid-descending or junction of the sigmoid and descending colon. Pain and gas were individually measured by a 100 mm long Visual Analog Scale (VAS). The VAS does not have any pre-set marks between the extremes. For the pain VAS, 0 means no pain and 100 mm means extreme pain. For the gas VAS, 0 means no gas sensation and 100 mm means extreme gas sensation. The investigator measures the mark made by the participant in mm and records this for the value of either pain or gas.
Time Frame Approximately 60 minutes after drug administration
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pregabalin 75 mg Pregabalin 200 mg Placebo
Hide Arm/Group Description:
Subjects randomized to this arm received a single dose of pregabalin 75 mg orally
Subjects randomized to this arm received a single dose of pregabalin 200 mg orally
Subjects randomized to this arm received a single dose of placebo medication orally
Overall Number of Participants Analyzed 20 19 21
Mean (Standard Deviation)
Unit of Measure: mm
Sensation ratings for pain at 30 mm Hg 47.4  (28.3) 36.1  (28.4) 46.0  (28.7)
Sensation ratings for gas at 30 mm Hg 53.4  (27.9) 33.2  (19.6) 46.6  (22.3)
3.Primary Outcome
Title Colonic Compliance
Hide Description Colonic compliance is a measure of the "stiffness" of the colon, that is, what pressure was needed to reach half the maximum value of the colon. After the barostat balloon catheter was inserted in the mid-descending or junction of the sigmoid and descending colon, the balloon was inflated. After an initial conditioning distension to 20 mm Hg, colonic compliance was measured by step-wise inflation with increments of 4 mm Hg. Colonic compliance was analyzed by a validated linear interpolation method. The pressure at half maximum volume serves as a summary of colonic compliance.
Time Frame Approximately 60 minutes after drug administration
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pregabalin 75 mg Pregabalin 200 mg Placebo
Hide Arm/Group Description:
Subjects randomized to this arm received a single dose of pregabalin 75 mg orally
Subjects randomized to this arm received a single dose of pregabalin 200 mg orally
Subjects randomized to this arm received a single dose of placebo medication orally
Overall Number of Participants Analyzed 20 19 21
Mean (Standard Deviation)
Unit of Measure: mm Hg
17.6  (5.1) 19.1  (4.6) 17.4  (4.8)
4.Primary Outcome
Title Postprandial Colonic Tone [Reported] as the Symmetric Percent [Change]in Baseline Colonic Barostat Balloon Volume
Hide Description The symmetric percent reduction in baseline colonic barostat balloon volume during the first 30 minutes postprandially (PP) corrected for the preprandial (30 min) tone, (symmetric percent change= 100*log_e[fasting/PP]). A positive symmetric percent change reflects a decrease in barostat balloon volume indicating a reduction in colonic tone. (The balloon was placed in the mid-descending or junction of the sigmoid and descending colon.)
Time Frame The first 30 minutes postprandially, and preprandial (30 minutes)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pregabalin 75 mg Pregabalin 200 mg Placebo
Hide Arm/Group Description:
Subjects randomized to this arm received a single dose of pregabalin 75 mg orally
Subjects randomized to this arm received a single dose of pregabalin 200 mg orally
Subjects randomized to this arm received a single dose of placebo medication orally
Overall Number of Participants Analyzed 20 19 21
Mean (Standard Deviation)
Unit of Measure: Symmetric percentage change
21.9  (12.4) 35.3  (25.2) 27.8  (21.8)
5.Primary Outcome
Title Postprandial Motility Index Over 30 Minutes
Hide Description The first 30 minute postprandial motility index (MI), MI = log_e [(number of contractions * sum of amplitudes)+1]
Time Frame 30 minutes after the meal
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pregabalin 75 mg Pregabalin 200 mg Placebo
Hide Arm/Group Description:
Subjects randomized to this arm received a single dose of pregabalin 75 mg orally
Subjects randomized to this arm received a single dose of pregabalin 200 mg orally
Subjects randomized to this arm received a single dose of placebo medication orally
Overall Number of Participants Analyzed 20 19 21
Mean (Standard Deviation)
Unit of Measure: log mm Hg
Motility index proximal colon at 30 minutes 11.264  (1.609) 11.764  (1.357) 11.465  (1.339)
Motility index distal colon at 30 minutes 8.806  (3.095) 9.783  (2.849) 9.879  (2.235)
6.Secondary Outcome
Title Sensory Threshold for Gas
Hide Description The sensory threshold for first perception of gas was measured by stepwise inflation of the balloon in increments of 4 mm Hg at 60 second intervals. (The balloon was placed in the mid-descending or junction of the sigmoid and descending colon.) During this assessment participants were asked to report when they had the first perception of gas. The investigator recorded the threshold pressure at which the participants reported this sensation.
Time Frame Approximately 60 minutes after drug administration
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pregabalin 75 mg Pregabalin 200 mg Placebo
Hide Arm/Group Description:
Subjects randomized to this arm received a single dose of pregabalin 75 mg orally
Subjects randomized to this arm received a single dose of pregabalin 200 mg orally
Subjects randomized to this arm received a single dose of placebo medication orally
Overall Number of Participants Analyzed 20 19 21
Mean (Standard Deviation)
Unit of Measure: mm Hg
27.6  (18.3) 34.3  (11.1) 34.5  (16.8)
7.Secondary Outcome
Title Sensation Ratings for Pain at 16, 24, and 36 mm Hg Distension
Hide Description The mm Hg distensions refer to the barostat balloon, which was placed in the mid-descending or junction of the sigmoid and descending colon. Pain sensation was measured by a 100 mm long Visual Analog Scale (VAS). The VAS does not have any pre-set marks between the extremes. For the pain VAS, 0 means no pain and 100 mm means extreme pain. The investigator measures the mark made by the participant in mm and records this for the value of pain.
Time Frame Approximately 60 minutes after drug administration
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pregabalin 75 mg Pregabalin 200 mg Placebo
Hide Arm/Group Description:
Subjects randomized to this arm received a single dose of pregabalin 75 mg orally
Subjects randomized to this arm received a single dose of pregabalin 200 mg orally
Subjects randomized to this arm received a single dose of placebo medication orally
Overall Number of Participants Analyzed 20 19 21
Mean (Standard Deviation)
Unit of Measure: mm
Sensation ratings of pain at 16 mm distension 28.70  (24.27) 29.00  (28.47) 34.29  (28.24)
Sensation ratings of pain at 24 mm distension 43.00  (30.66) 36.84  (28.55) 39.48  (29.78)
Sensation ratings of pain at 36 mm distension 44.30  (23.96) 43.37  (26.94) 47.62  (30.45)
8.Secondary Outcome
Title Sensation Ratings for Gas at 16, 24, and 36 mm Hg Distension
Hide Description The mm Hg distensions refer to the barostat balloon, which was placed in the mid-descending or junction of the sigmoid and descending colon. Gas sensation was measured by a 100 mm long Visual Analog Scale (VAS). The VAS does not have any pre-set marks between the extremes. For the gas VAS, 0 means no gas sensation and 100 mm means extreme gas sensation. The investigator measures the mark made by the participant in mm and records this for the value of either pain or gas.
Time Frame Approximately 60 minutes after drug administration
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pregabalin 75 mg Pregabalin 200 mg Placebo
Hide Arm/Group Description:
Subjects randomized to this arm received a single dose of pregabalin 75 mg orally
Subjects randomized to this arm received a single dose of pregabalin 200 mg orally
Subjects randomized to this arm received a single dose of placebo medication orally
Overall Number of Participants Analyzed 20 19 21
Mean (Standard Deviation)
Unit of Measure: mm
Sensation Ratings for Gas at 16 mm Hg distention 37.40  (25.10) 30.00  (25.25) 37.14  (22.62)
Sensation Ratings for Gas at 24 mm Hg distention 44.05  (26.51) 32.00  (21.83) 42.76  (23.87)
Sensation Ratings for Gas at 36 mm Hg distention 49.65  (25.06) 36.58  (22.42) 46.24  (22.36)
9.Secondary Outcome
Title Gas Sensation Rating Averaged Across 4 Distension Pressures (16, 24, 30, and 36 mg Hg)
Hide Description The mm Hg distensions refer to the barostat balloon, which was placed in the mid-descending or junction of the sigmoid and descending colon. Gas sensation was measured by a 100 mm long Visual Analog Scale (VAS). The VAS does not have any pre-set marks between the extremes. For the gas VAS, 0 means no gas sensation and 100 mm means extreme gas sensation. The investigator measures the mark made by the participant in mm and records this for the value of gas. The values across the 4 distension pressures were averaged for this outcome measure.
Time Frame Approximately 60 minutes after drug administration
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pregabalin 75 mg Pregabalin 200 mg Placebo
Hide Arm/Group Description:
Subjects randomized to this arm received a single dose of pregabalin 75 mg orally
Subjects randomized to this arm received a single dose of pregabalin 200 mg orally
Subjects randomized to this arm received a single dose of placebo medication orally
Overall Number of Participants Analyzed 20 19 21
Mean (Standard Deviation)
Unit of Measure: mm
43.379  (23.413) 33.391  (22.106) 41.789  (22.278)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin 75 mg, Pregabalin 200 mg, Placebo
Comments ANCOVA for overall treatment effects
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.14
Comments P-value not adjusted for multiple comparisons; alpha level of 0.05 used
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter mean value for 200 mg Pregabalin
Estimated Value 33.391
Parameter Dispersion
Type: Standard Deviation
Value: 22.106
Estimation Comments A confidence interval was not calculated
10.Secondary Outcome
Title Pain Sensation Rating Averaged Across 4 Distension Pressures (16, 24, 30, and 36 mg Hg)
Hide Description The mm Hg distensions refer to the barostat balloon, which was placed in the mid-descending or junction of the sigmoid and descending colon. Pain sensation was measured by a 100 mm long Visual Analog Scale (VAS). The VAS does not have any pre-set marks between the extremes. For the pain VAS, 0 means no pain and 100 mm means extreme pain. The investigator measures the mark made by the participant in mm and records this for the value of pain. The values across the 4 distension pressures were averaged for this outcome measure.
Time Frame Approximately 60 minutes after drug administration
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pregabalin 75 mg Pregabalin 200 mg Placebo
Hide Arm/Group Description:
Subjects randomized to this arm received a single dose of pregabalin 75 mg orally
Subjects randomized to this arm received a single dose of pregabalin 200 mg orally
Subjects randomized to this arm received a single dose of placebo medication orally
Overall Number of Participants Analyzed 20 19 21
Mean (Standard Deviation)
Unit of Measure: mm
44.364  (23.478) 35.301  (22.295) 43.286  (23.678)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin 75 mg, Pregabalin 200 mg, Placebo
Comments ANCOVA for overall treatment effects
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.12
Comments P-value not adjusted for multiple comparisons; alpha level of 0.05 used
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter mean value for 200 mg Pregabalin
Estimated Value 35.301
Parameter Dispersion
Type: Standard Deviation
Value: 22.295
Estimation Comments A confidence interval was not calculated
Time Frame 5 hours after tube placement
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Pregabalin 75 mg Pregabalin 200 mg Placebo
Hide Arm/Group Description Subjects randomized to this arm received a single dose of pregabalin 75 mg orally Subjects randomized to this arm received a single dose of pregabalin 200 mg orally Subjects randomized to this arm received a single dose of placebo medication orally
All-Cause Mortality
Pregabalin 75 mg Pregabalin 200 mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Hide Serious Adverse Events
Pregabalin 75 mg Pregabalin 200 mg Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/20 (0.00%)      0/19 (0.00%)      0/21 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Pregabalin 75 mg Pregabalin 200 mg Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   14/20 (70.00%)      19/19 (100.00%)      9/21 (42.86%)    
Cardiac disorders       
Tachycardia *  9/20 (45.00%)  9 7/19 (36.84%)  7 8/21 (38.10%)  8
Nervous system disorders       
Drowsiness *  4/20 (20.00%)  4 7/19 (36.84%)  7 1/21 (4.76%)  1
Dizziness *  1/20 (5.00%)  1 7/19 (36.84%)  7 0/21 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Michael Camilleri
Organization: Mayo Clinic
Phone: 507-266-2305
EMail: camilleri.michael@mayo.edu
Layout table for additonal information
Responsible Party: Michael Camilleri, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01094808    
Other Study ID Numbers: 09-008469
1RC1DK086182 ( U.S. NIH Grant/Contract )
R01DK079866 ( U.S. NIH Grant/Contract )
R01DK067071 ( U.S. NIH Grant/Contract )
UL1RR024150 ( U.S. NIH Grant/Contract )
First Submitted: March 24, 2010
First Posted: March 29, 2010
Results First Submitted: January 26, 2012
Results First Posted: March 6, 2012
Last Update Posted: March 7, 2012