Phase 4
N=13
Study to Investigate Prucalopride vs. Polyethylene Glycol 3350 on Colon Activity
Chronic Constipation
Bottom Line
View on ClinicalTrials.gov: NCT01707667 ↗Enrolled (actual)
13
Serious AEs
0.0%
Results posted
Oct 2014
Primary outcome: Primary: The Number of High-Amplitude Propagating Contractions (HAPC) — 8.7; 2.9 Number of HAPC with amplitude ≥100mmHg — p=0.012
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- prucalopride (Drug); PEG 3350 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Shire
- Primary completion
- Nov 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Number of High-Amplitude Propagating Contractions (HAPC) |
8.7; 2.9 | 0.012 sig |
| SECONDARY Area Under the Concentration Curve (AUC) of All HAPCs |
110204.1; 41152.7 | 0.079 |
| SECONDARY The Mean Amplitude of HAPC |
199.0; 189.8 | 0.717 |
| SECONDARY Time to First HAPC |
4.5; NA | 0.295 |
| SECONDARY Propagation Velocity of HAPC |
0.467; 0.646 | 0.180 |
| SECONDARY Duration of HAPC |
84.9; 69.1 | 0.225 |
| SECONDARY Motility Index |
9.467; 8.312; 13.661; 13.349; 14.208; 14.390 | — |
Summary
To evaluate the different effects of prucalopride and PEG 3350 + electrolytes on colon motor activity in subjects that are chronically constipated.
Eligibility Criteria
Inclusion Criteria
- Chronic constipation
- Male or female ages 18-75 years
- Non-pregnant, non-lactating female
Exclusion Criteria
- Drug-induced constipation
- Subjects suffering from secondary causes of chronic constipation, such as:
- Endocrine disorders, e.g. hypopituitarism, hypothyroidism, hypercalcemia, pseudohypoparathyroidism, pheochromocytoma or glucagon-producing tumors, unless these are controlled by appropriate medical therapy.
- Metabolic disorders, e.g. porphyria, uremia, hypokalemia or amyloid neuropathy, unless these are controlled by appropriate medical therapy
- Neurological disorders, e.g. Parkinson's disease, cerebral tumors, cerebrovascular accidents, multiple sclerosis, meningocele, aganglionosis, hypoganglionosis, hyperganglionosis, autonomic neuropathy or neuropathy due to chemotherapy, spinal cord injury, Chaga's disease, or major depression
- Surgery.
- Subjects with insulin-dependent diabetes mellitus
- Rectal evacuation disorder/outlet obstruction
- Subjects with intestinal perforation or obstruction
- Severe renal impairment
- Subjects with a history of alcohol or drug abuse
- Subjects with lactose intolerance
- Subjects with clinically significant cardiac, vascular, liver, pulmonary, endocrine, neurological or psychiatric disorders
Data sourced from ClinicalTrials.gov (NCT01707667). 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.