Phase 4
N=18
Pregabalin on Colonic Motor and Sensory Function in Constipation Predominant Irritable Bowel Syndrome
Irritable Bowel Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT01331213 ↗Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Mar 2014
Primary outcome: Primary: Colonic Compliance — 18.96; 16.86; 15.99; 15.75 mm Hg
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Pregabalin (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- Feb 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Colonic Compliance |
18.96; 16.86; 15.99; 15.75 | — |
| PRIMARY Postprandial Colonic Tone [Reported as the Symmetric Percent [Change} in Baseline Colonic Barostat Balloon Volume |
-22.34; -24.45 | — |
| PRIMARY Sensory Threshold for Pain |
36.0; 38.0 | — |
| PRIMARY Overall Sensory Ratings in Response to 16, 24, 30 and 36 mm Hg Distensions. |
53.0; 52.3; 57.43; 59.60; 64.0; 60.3 | — |
| SECONDARY Fasting Colonic Tone |
120.4; 116.8 | — |
| SECONDARY Colonic Motility Index |
13.69; 12.27; 11.72; 10.21 | — |
| SECONDARY Post-treatment Sensory Threshold for Gas |
24.0; 19.2 | — |
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. 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. 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. Single-dose pregabalin 200mg increases the colonic phasic and tonic response to a standardized meal.
Eligibility Criteria
Inclusion criteria
- Male or females with Constipation Predominant IBS, age 18-65
Exclusion criteria
- 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
Data sourced from ClinicalTrials.gov (NCT01331213). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.