Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 52 of 424 for:    Pregabalin

Pregabalin on Colonic Motor and Sensory Function in Constipation Predominant Irritable Bowel Syndrome

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: NCT01331213
Recruitment Status : Completed
First Posted : April 7, 2011
Results First Posted : March 3, 2014
Last Update Posted : March 3, 2014
Sponsor:
Collaborator:
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 Irritable Bowel Syndrome
Interventions Drug: Pregabalin
Drug: Placebo
Enrollment 18
Recruitment Details Participants were enrolled in the study between 4/2011 and 3/2012 at the Mayo Clinic in Rochester, Minnesota.
Pre-assignment Details  
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description Subjects randomized to this arm received a single dose of pregabalin 200mg orally. Subjects randomized to this arm received a single dose of placebo orally.
Period Title: Overall Study
Started 8 10
Completed 8 10
Not Completed 0 0
Arm/Group Title Pregabalin Placebo Total
Hide Arm/Group Description Subjects randomized to this arm received a single dose of pregabalin 200mg orally. Subjects randomized to this arm received a single dose of placebo orally. Total of all reporting groups
Overall Number of Baseline Participants 8 10 18
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 8 participants 10 participants 18 participants
44  (5.88) 44.1  (11.51) 44.06  (9.19)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 10 participants 18 participants
Female
8
 100.0%
9
  90.0%
17
  94.4%
Male
0
   0.0%
1
  10.0%
1
   5.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 8 participants 10 participants 18 participants
8 10 18
1.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 volume 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 baseline (1 hour before drug administration), post-treatment (1 hour after drug administration)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description:
Subjects randomized to this arm received a single dose of pregabalin 200mg orally.
Subjects randomized to this arm received a single dose of placebo orally.
Overall Number of Participants Analyzed 8 10
Mean (Standard Deviation)
Unit of Measure: mm Hg
Baseline 18.96  (4.84) 16.86  (8.97)
Post-Treatment 15.99  (6.4) 15.75  (7.89)
2.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 Placebo
Hide Arm/Group Description:
Subjects randomized to this arm received a single dose of pregabalin 200mg orally.
Subjects randomized to this arm received a single dose of placebo orally.
Overall Number of Participants Analyzed 8 10
Mean (Standard Deviation)
Unit of Measure: Symmetric percentage change
-22.34  (12.98) -24.45  (12.3)
3.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 Placebo
Hide Arm/Group Description:
Subjects randomized to this arm received a single dose of pregabalin 200mg orally.
Subjects randomized to this arm received a single dose of placebo orally.
Overall Number of Participants Analyzed 8 10
Mean (Standard Deviation)
Unit of Measure: mm Hg
36.0  (17.59) 38.0  (21.02)
4.Primary Outcome
Title Overall Sensory Ratings in Response to 16, 24, 30 and 36 mm Hg Distensions.
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 Placebo
Hide Arm/Group Description:
Subjects randomized to this arm received a single dose of pregabalin 200mg orally.
Subjects randomized to this arm received a single dose of placebo orally.
Overall Number of Participants Analyzed 8 10
Mean (Standard Deviation)
Unit of Measure: mm
Sensation ratings of pain at 16 mm Hg distension 53.0  (11.83) 52.3  (20.44)
Sensation ratings of pain at 24 mm Hg distension 57.43  (30.49) 59.60  (26.71)
Sensation ratings of pain at 30 mm Hg distension 64.0  (26.12) 60.3  (24.99)
Sensation ratings of pain at 36 mm Hg distension 59.0  (21.93) 53.7  (33.4)
5.Secondary Outcome
Title Fasting Colonic Tone
Hide Description Colonic tone is a measurement of the volume of the colon. Colonic tone was assessed by noting the changes in the balloon volume in the presence of a constant operating pressure in the balloon (in the barostat-manometric assembly placed in the colon.)
Time Frame Approximately 60 minutes after drug administration
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description:
Subjects randomized to this arm received a single dose of pregabalin 200mg orally.
Subjects randomized to this arm received a single dose of placebo orally.
Overall Number of Participants Analyzed 8 10
Mean (Standard Deviation)
Unit of Measure: mL
120.4  (12.76) 116.8  (24.75)
6.Secondary Outcome
Title Colonic Motility Index
Hide Description The postprandial motility index (MI)=log_e[number of contractions * sum of amplitudes) + 1] A normal fasting average motility index (MI) would be about 12. An increase in MI means an increase in the phasic contractions (in contrast to tone) which is measured as a change in volume of the barostatically-controlled balloon. (Therefore, an increase in MI means that the meal is moving more quickly through the colon.)
Time Frame Approximately 1 hour after meal
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description:
Subjects randomized to this arm received a single dose of pregabalin 200mg orally.
Subjects randomized to this arm received a single dose of placebo orally.
Overall Number of Participants Analyzed 8 10
Mean (Standard Deviation)
Unit of Measure: log mm Hg
Post-treatment, descending colon 13.69  (0.82) 12.27  (2.09)
Post-treatment, sigmoid colon 11.72  (1.58) 10.21  (3.20)
7.Secondary Outcome
Title Post-treatment 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 Placebo
Hide Arm/Group Description:
Subjects randomized to this arm received a single dose of pregabalin 200mg orally.
Subjects randomized to this arm received a single dose of placebo orally.
Overall Number of Participants Analyzed 8 10
Mean (Standard Deviation)
Unit of Measure: mm Hg
24.0  (12.65) 19.2  (13.31)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description Subjects randomized to this arm received a single dose of pregabalin 200mg orally. Subjects randomized to this arm received a single dose of placebo orally.
All-Cause Mortality
Pregabalin Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Pregabalin Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)   0/10 (0.00%) 
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 (%) Affected / at Risk (%)
Total   0/8 (0.00%)   0/10 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Michael Camilleri
Organization: Mayo Clinic
Phone: 507-266-2305
Responsible Party: Michael Camilleri, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01331213     History of Changes
Other Study ID Numbers: 11-000485
UL1RR024150 ( U.S. NIH Grant/Contract )
First Submitted: April 6, 2011
First Posted: April 7, 2011
Results First Submitted: January 17, 2014
Results First Posted: March 3, 2014
Last Update Posted: March 3, 2014