Phase 4
Completed N=62
Pregabalin and Colonic Function
Healthy
Source: ClinicalTrials.gov NCT01094808 ↗
Enrolled (actual)
62
Serious AEs
0.0%
Results posted
Mar 2012
Primary outcomePrimary: Sensory Threshold for Pain — 45.8; 46.7; 45.0 mm Hg
Summary
This study is being done to evaluate the effects of pregabalin, a drug approved for anticonvulsive therapy and for neuropathic pain, on colonic and sensory functions in healthy individuals.
The specific study hypotheses were as follows: 1) pregabalin increases sensation thresholds, decreases sensation ratings, and increases compliance in response to balloon distension in the colon; 2) pregabalin reduces colonic phasic and tonic motility in response to a standardized meal; and 3) sensation ratings are lower with higher colonic compliance.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sensory Threshold for Pain |
45.8; 46.7; 45.0 | — |
| PRIMARY Sensation Ratings for Pain and Gas at 30 mm Hg Distension Above Baseline Operating Pressure |
47.4; 36.1; 46.0; 53.4; 33.2; 46.6 | — |
| PRIMARY Colonic Compliance |
17.6; 19.1; 17.4 | — |
| PRIMARY Postprandial Colonic Tone [Reported] as the Symmetric Percent [Change]in Baseline Colonic Barostat Balloon Volume |
21.9; 35.3; 27.8 | — |
| PRIMARY Postprandial Motility Index Over 30 Minutes |
11.264; 11.764; 11.465; 8.806; 9.783; 9.879 | — |
| SECONDARY Sensory Threshold for Gas |
27.6; 34.3; 34.5 | — |
| SECONDARY Sensation Ratings for Pain at 16, 24, and 36 mm Hg Distension |
28.70; 29.00; 34.29; 43.00; 36.84; 39.48 | — |
| SECONDARY Sensation Ratings for Gas at 16, 24, and 36 mm Hg Distension |
37.40; 30.00; 37.14; 44.05; 32.00; 42.76 | — |
| SECONDARY Gas Sensation Rating Averaged Across 4 Distension Pressures (16, 24, 30, and 36 mg Hg) |
43.379; 33.391; 41.789 | 0.14 |
| SECONDARY Pain Sensation Rating Averaged Across 4 Distension Pressures (16, 24, 30, and 36 mg Hg) |
44.364; 35.301; 43.286 | 0.12 |
Eligibility Criteria
Inclusion criteria
- Healthy males or females
Exclusion criteria
- Abdominal surgery other than appendectomy, laparoscopic cholecystectomy, cesarean section, vaginal or laparoscopic hysterectomy or tubal ligation
- A history of chronic gastrointestinal or systemic illnesses that could affect gastrointestinal motility
- Any history of hypertension
- Use of medications that may alter gastrointestinal motility or interact with the study medications
- Use of any of the study medications within the past 30 days
- Pregnancy
- Chronic renal insufficiency (serum creatinine >1.5 mg/dL)
- Psychiatric or psychologic dysfunction.
Data sourced from ClinicalTrials.gov (NCT01094808). 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. Informational only — not medical advice.