Effects of Oral PEG 3350 on Electrolyte Balance

This study has been completed.
Sponsor:
Information provided by:
Norgine
ClinicalTrials.gov Identifier:
NCT00868985
First received: March 24, 2009
Last updated: NA
Last verified: March 2009
History: No changes posted
  Purpose

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 Intervention Phase
Chronic Constipation
Drug: PEG 3350 plus electrolytes
Drug: PEG 3350 without electrolytes
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Norgine:

Primary Outcome Measures:
  • Electrolyte profile in blood, urine and faeces, serum osmolality and effect on the renin/aldosterone ratio [ Time Frame: Ten days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Amount of PEG 3350 in plasma, urine and faeces [ Time Frame: Ten days ] [ Designated as safety issue: No ]

Enrollment: 114
Study Start Date: January 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00868985

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

No publications provided

Responsible Party: Vice President Clinical Development, Norgine Ltd
ClinicalTrials.gov Identifier: NCT00868985     History of Changes
Other Study ID Numbers: PEG-01/2007(ELE)
Study First Received: March 24, 2009
Last Updated: March 24, 2009
Health Authority: Romania: State Institute for Drug Control

Additional relevant MeSH terms:
Constipation
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on September 18, 2014