Effects of Oral PEG 3350 on Electrolyte Balance

NCT00868985 | Completed Phase 1

• 1 other identifier: PEG-01/2007(ELE)
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Electrolyte profile in blood, urine and faeces, serum osmolality and effect on the renin/aldosterone ratio

  Ten days

Secondary Outcomes (1)

• Amount of PEG 3350 in plasma, urine and faeces

  Ten days

Study Arms (2)

PEG 3350 plus electrolytes

EXPERIMENTAL

Patients were dosed with PEG 3350 with electrolytes

Drug: PEG 3350 plus electrolytes

PEG 3350 without electrolytes

EXPERIMENTAL

Patients were dosed with PEG 3350 without electrolytes

Drug: PEG 3350 without electrolytes

Interventions

PEG 3350 plus electrolytes DRUG

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

PEG 3350 plus electrolytes

PEG 3350 without electrolytes DRUG

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

PEG 3350 without electrolytes

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female patients between 18 and 70 years of age with confirmed chronic constipation after the run-in period; this is defined as patients who have recorded in their diaries less than 3 bowel motions/week plus one of the following symptoms:
• Straining during at least 25% of defecations Lumpy or hard stools with at least 25% of defecations Sense of incomplete evacuation with at least 25% of defecation Sensation of ano-rectal blockage with at least 25% of defecation Manula manoeuvres of facilitate at least 25% of defecation
• Willing and able to follow the entire procedure and to comply with the study instructions.
• For the subgroup of patient volunteers taking ACE-inhibitors (36 subjects): A history of hypertension, with blood pressure controlled to acceptable levels by a stable regimen of ACE-inhibitors.

You may not qualify if:

• Participation in a clinical research study involving investigational drugs or dosage forms within the previous 3 months.
• Subjects who have previously been enrolled in this study.
• Subjects who are currently or have a history of abuse of alcohol, non-medical drugs, medicinal drugs or other substance abuse eg solvents.
• Major surgery in within the last 12 months.
• Malignant tumors within the last 5 years.
• Uncontrolled blood pressure or terminal cardiac, liver and/or kidney diseases.
• Clinical relevant acute gastrointestinal tract disease, including evidence of intestinal perforation or obstruction, paralytic ileus, toxic megacolon, severe inflammatory conditions.
• Acute urinary tract conditions, including cystitis.
• Patients with diagnosis or evidence of the following diseases: Hypothyroidism, diabetes mellitus, porphyria, pituitary gland insufficiency, pheochromocytoma, glucagonoma, neurological diseases (eg Hirschprung disease, neurofibromatosis, Chagas disease, stroke, autonomous neuropathy, intestinal pseudoobstruction, Multiple sclerosis, medullar injury, Parkinson disease, Shy-Drager syndrome), collagenosis, vasculitis, myopathy (e.g. sclerodermatitis, amyloidosis, dermatomyositis), intoxication with heavy metals (e.g. Pb, As, Hg)
• Concomitant medication:
• Use of any oral purgatives/laxatives and prokinetics within the last 14 days prior to dosing.
• Use of any opioids, anti-cholinergics, tricyclic anti-depressants, MAOIs, Fe preparations, within the 4 weeks prior to dosing.
• Use of any Ca-antagonists, Beta-blockers or diuretics within the last 4 weeks prior to dosing.
• other medication which in the opinion of the Investigator could interfere with the principal function of the GI tract.
• Subject unable to provide written consent.

Sponsors & Collaborators

• Norgine: lead

Study Sites (1)

IFE Human Pharmacology

Timișoara, Ro-300244, Romania

Location

MeSH Terms

Interventions

polyethylene glycol 3350; Electrolytes

Intervention Hierarchy (Ancestors)

Inorganic Chemicals

Study Officials

• Hans-Jürgen Gruss, MD

  Norgine

  STUDY DIRECTOR

• Rodica Cinca, MD

  IFE Human Pharmacology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 24, 2009
• First Posted: March 25, 2009
• Study Start: January 1, 2008
• Primary Completion: August 1, 2008
• Last Updated: March 25, 2009

Record last verified: 2009-03

Locations

RO (1)