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

NCT01331213 | Completed Phase 4 Results

• 2 other identifiers: 11-000485UL1RR024150
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

The general aim of the current study is to describe the effect of pregabalin on colonic and sensory functions in adults with constipation predominant irritable bowel syndrome (IBS-C). Study hypotheses:

1. 1.Single-dose pregabalin 200mg increases sensation thresholds and decreases sensation ratings in response to balloon distension in the colon relative to pre-pregabalin treatment.
2. 2.Single-dose pregabalin 200 mg will increase colonic compliance and decrease colonic pain and gas thresholds in patients with irritable bowel syndrome constipation predominant.
3. 3.Single-dose pregabalin 200mg increases the colonic phasic and tonic response to a standardized meal.

Conditions

Irritable Bowel Syndrome

Keywords

Pregabalin; Irritable Bowel Syndrome; motor; sensation; colon; human

Outcome Measures

Primary Outcomes (4)

• Colonic Compliance

  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.

  baseline (1 hour before drug administration), post-treatment (1 hour after drug administration)

• Postprandial Colonic Tone [Reported as the Symmetric Percent [Change} in Baseline Colonic Barostat Balloon Volume

  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.)

  The first 30 minutes postprandially, and preprandial (30 minutes)

• Sensory Threshold for Pain

  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.

  approximately 60 minutes after drug administration

• Overall Sensory Ratings in Response to 16, 24, 30 and 36 mm Hg Distensions.

  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.

  Approximately 60 minutes after drug administration

Secondary Outcomes (3)

• Fasting Colonic Tone

  Approximately 60 minutes after drug administration

• Colonic Motility Index

  Approximately 1 hour after meal

• Post-treatment Sensory Threshold for Gas

  Approximately 60 minutes after drug administration

Study Arms (2)

Pregabalin

ACTIVE COMPARATOR

Subjects randomized to this arm received a single dose of pregabalin 200mg orally.

Drug: Pregabalin

Placebo

PLACEBO COMPARATOR

Subjects randomized to this arm received a single dose of placebo orally.

Drug: Placebo

Interventions

Pregabalin DRUG

FDA approved medication (capsules) at 200mg dose.

Also known as: Lyrica

Pregabalin

Placebo DRUG

Placebo capsules

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Male or females with Constipation Predominant IBS, age 18-65

You may not qualify if:

• Abdominal surgery other than appendectomy, laparoscopic cholecystectomy, cesarean section, vaginal or laparoscopic hysterectomy or tubal ligation
• Uncontrolled hypertension
• Use of medications that may interact with the study medication
• Use of any of the study medications within the past 30 days
• Pregnancy
• History of chronic renal insufficiency (serum creatinine \>1.5mg/dL)
• Psychiatric or psychologic dysfunction
• Current pelvic floor dysfunction
• diagnosis of lactose intolerance

Sponsors & Collaborators

• Mayo Clinic: lead
• National Center for Research Resources (NCRR): collaborator

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Dr. Michael Camilleri
• Organization: Mayo Clinic

camilleri.michael@mayo.edu

507-266-2305

Study Officials

• Michael Camilleri, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 6, 2011
• First Posted: April 7, 2011
• Study Start: April 1, 2011
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: March 3, 2014
• Results First Posted: March 3, 2014

Record last verified: 2014-01

Locations

US (1)