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Effects of Oral PEG 3350 on Electrolyte Balance

NCT00868985 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 114

Last updated 2009-03-25

No results posted yet for this study

Summary

The study is to evaluate the influence of three different doses of PEG 3350 with or without electrolytes on the electrolyte balance in patient volunteers with confirmed chronic constipation.

Conditions

  • Chronic Constipation

Interventions

DRUG

PEG 3350 plus electrolytes

Each patient was treated with PEG 3350 with electrolytes for 10 days at a dose of either one, two or three sachets per day.

DRUG

PEG 3350 without electrolytes

Each patient was treated with PEG 3350 for 10 days at a dose of either one, two or three sachets per day.

Sponsors & Collaborators

Principal Investigators

  • Hans-Jürgen Gruss, MD · Norgine

  • Rodica Cinca, MD · IFE Human Pharmacology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2008-08-31

Countries

  • Romania

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00868985 on ClinicalTrials.gov