NCT01707667

Brief Summary

To evaluate the different effects of prucalopride and PEG 3350 + electrolytes on colon motor activity in subjects that are chronically constipated.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Feb 2013

Shorter than P25 for phase_4

Geographic Reach
3 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 12, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 16, 2012

Completed
4 months until next milestone

Study Start

First participant enrolled

February 27, 2013

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 27, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 27, 2013

Completed
11 months until next milestone

Results Posted

Study results publicly available

October 22, 2014

Completed
Last Updated

July 2, 2021

Status Verified

June 1, 2021

Enrollment Period

9 months

First QC Date

October 12, 2012

Results QC Date

October 17, 2014

Last Update Submit

June 10, 2021

Conditions

Chronic Constipation

Outcome Measures

Primary Outcomes (1)

  • The Number of High-Amplitude Propagating Contractions (HAPC)

    Manometry recordings were read by an experienced gastroenterologist who was blinded to the treatment each subject received. The tracings were analyzed using computer-based validated software. HAPC and manometry data were available for every sensor as well as average values for each HAPC and manometry time point. The primary outcome analysis of HAPC data used the following threshold: Mean amplitude ≥100mmHg and extension ≥20cm (9 sensors).

    over 12 hours post-dose

Secondary Outcomes (6)

  • Area Under the Concentration Curve (AUC) of All HAPCs

    over 12 hours post-dose

  • The Mean Amplitude of HAPC

    over 12 hours post-dose

  • Time to First HAPC

    over 12 hours post-dose

  • Propagation Velocity of HAPC

    over 12 hours post-dose

  • Duration of HAPC

    over 12 hours post-dose

  • +1 more secondary outcomes

Study Arms (2)

Prucalopride

EXPERIMENTAL
Drug: prucalopride

PEG 3350

ACTIVE COMPARATOR
Drug: PEG 3350

Interventions

prucaloprideDRUG

One 2 mg tablet orally administered on Day 1

Also known as: Resolor (Marketed name in Europe)
Prucalopride
PEG 3350DRUG

13.8g polyethylene glycol (PEG) 3350 with sodium bicarbonate, sodium chloride, and potassium chloride as a solution in water. Administered twice orally on Day 1(once in the morning and once prior to lunch).

Also known as: Movicol
PEG 3350

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chronic constipation
  • Male or female ages 18-75 years
  • Non-pregnant, non-lactating female

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Oklahoma Foundation for Digestive Research

Oklahoma City, Oklahoma, 73104, United States

Location

UNIVERSITY OF LEUVEN, UNVERSITY HOSPITAL, Gasthuisberg

Leuven, 3000, Belgium

Location

Barts Health NHS Trust

Whitechapel, London, E1 1BB, United Kingdom

Location

Related Publications (1)

  • Miner PB Jr, Camilleri M, Burton D, Achenbach H, Wan H, Dragone J, Mellgard B. Prucalopride induces high-amplitude propagating contractions in the colon of patients with chronic constipation: a randomized study. Neurogastroenterol Motil. 2016 Sep;28(9):1341-8. doi: 10.1111/nmo.12832. Epub 2016 Jun 7.

    PMID: 27270968DERIVED

MeSH Terms

Interventions

prucalopridepolyethylene glycol 3350

Results Point of Contact

Title
Study Director
Organization
Shire
ClinicalTransparency@shire.com
+1 866 842 5335

Study Officials

  • Study Director

    Takeda

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 12, 2012

First Posted

October 16, 2012

Study Start

February 27, 2013

Primary Completion

November 27, 2013

Study Completion

November 27, 2013

Last Updated

July 2, 2021

Results First Posted

October 22, 2014

Record last verified: 2021-06

Locations

GB(1)US(1)BE(1)