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Effects of Oral PEG 3350 on Electrolyte Balance

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ClinicalTrials.gov Identifier: NCT00868985
Recruitment Status : Completed
First Posted : March 25, 2009
Last Update Posted : March 25, 2009
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Chronic Constipation Drug: PEG 3350 plus electrolytes Drug: PEG 3350 without electrolytes Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 114 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Oral PEG 3350 on the Electrolyte Balance in Patient Volunteers With Chronic Constipation:Pharmacokinetic Evaluation
Study Start Date : January 2008
Primary Completion Date : August 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation
U.S. FDA Resources

Arm Intervention/treatment
Experimental: PEG 3350 plus electrolytes
Patients were dosed with PEG 3350 with electrolytes
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.
Experimental: PEG 3350 without electrolytes
Patients were dosed with PEG 3350 without electrolytes
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.

Primary Outcome Measures :
  1. Electrolyte profile in blood, urine and faeces, serum osmolality and effect on the renin/aldosterone ratio [ Time Frame: Ten days ]

Secondary Outcome Measures :
  1. Amount of PEG 3350 in plasma, urine and faeces [ Time Frame: Ten days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. The subjects written informed consent must be obtained prior to inclusion.
  2. 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

  3. Willing and able to follow the entire procedure and to comply with the study instructions.
  4. 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.

Exclusion Criteria:

  1. Participation in a clinical research study involving investigational drugs or dosage forms within the previous 3 months.
  2. Subjects who have previously been enrolled in this study.
  3. Subjects who are currently or have a history of abuse of alcohol, non-medical drugs, medicinal drugs or other substance abuse eg solvents.
  4. Major surgery in within the last 12 months.
  5. Malignant tumors within the last 5 years.
  6. Uncontrolled blood pressure or terminal cardiac, liver and/or kidney diseases.
  7. Clinical relevant acute gastrointestinal tract disease, including evidence of intestinal perforation or obstruction, paralytic ileus, toxic megacolon, severe inflammatory conditions.
  8. Acute urinary tract conditions, including cystitis.
  9. 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)
  10. Concomitant medication:

    1. Use of any oral purgatives/laxatives and prokinetics within the last 14 days prior to dosing.
    2. Use of any opioids, anti-cholinergics, tricyclic anti-depressants, MAOIs, Fe preparations, within the 4 weeks prior to dosing.
    3. Use of any Ca-antagonists, Beta-blockers or diuretics within the last 4 weeks prior to dosing.
    4. other medication which in the opinion of the Investigator could interfere with the principal function of the GI tract.
  11. Subject unable to provide written consent.
  12. Failure to satisfy the Investigator of fitness to participate for any other reason, including suspected non-compliance.
  13. Women of childbearing potential, who are not using and not willing to use medically reliable methods of contraception for the entire study duration, unless they are surgically sterilised/hysterectomised or any other criteria considered sufficiently reliable by the Investigator in individual cases.
  14. Patients with electrolytes disturbances or clinical signs of dehydration.
  15. Positive test at screening for HIV or hepatitis.
  16. Any clinically significant abnormal test results.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00868985

IFE Human Pharmacology
Timisoara, Romania, Ro-300244
Sponsors and Collaborators
Study Director: Hans-Jürgen Gruss, MD Norgine
Principal Investigator: Rodica Cinca, MD IFE Human Pharmacology

Responsible Party: Vice President Clinical Development, Norgine Ltd
ClinicalTrials.gov Identifier: NCT00868985     History of Changes
Other Study ID Numbers: PEG-01/2007(ELE)
First Posted: March 25, 2009    Key Record Dates
Last Update Posted: March 25, 2009
Last Verified: March 2009

Additional relevant MeSH terms:
Signs and Symptoms, Digestive
Signs and Symptoms
Polyethylene glycol 3350
Gastrointestinal Agents