Chronic ConstipationPhase 1NCT00868985
Effects of Oral PEG 3350 on Electrolyte Balance
A Phase 1 study testing PEG 3350 plus electrolytes and PEG 3350 without electrolytes in people with Chronic Constipation, run by Norgine at 1 site in Romania.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Constipation
- What is being tested?
- PEG 3350 plus electrolytes and PEG 3350 without electrolytes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteRomania
- Study dates
- Jan 2008to Aug 2008
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The subjects written informed consent must be obtained prior to inclusion.
- 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.
Who cannot join
- 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.
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- 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.
- Failure to satisfy the Investigator of fitness to participate for any other reason, including suspected non-compliance.
- 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.
- Patients with electrolytes disturbances or clinical signs of dehydration.
- Positive test at screening for HIV or hepatitis.
- Any clinically significant abnormal test results.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Oral PEG 3350 on the Electrolyte Balance in Patient Volunteers With Chronic Constipation:Pharmacokinetic Evaluation
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
- Being tested
- PEG 3350 plus electrolytes, PEG 3350 without electrolytes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEG 3350 plus electrolytesDrug
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 without electrolytesDrug
Each patient was treated with PEG 3350 for 10 days at a dose of either one, two or three sachets per day.
| Study group | Role | What they receive |
|---|---|---|
| PEG 3350 plus electrolytes | Experimental | Patients were dosed with PEG 3350 with electrolytes Receives: Drug: PEG 3350 plus electrolytes |
| PEG 3350 without electrolytes | Experimental | Patients were dosed with PEG 3350 without electrolytes Receives: Drug: PEG 3350 without electrolytes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electrolyte profile in blood, urine and faeces, serum osmolality and effect on the renin/aldosterone ratio
Measured: Ten days
Secondary outcomes (1)
Amount of PEG 3350 in plasma, urine and faeces
Measured: Ten days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2009 (estimated)
- Study startJan 2008
- Primary completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic ConstipationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norgine
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Hans-Jürgen Gruss, MD, Study director, NorgineRodica Cinca, MD, Principal investigator, IFE Human Pharmacology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00868985
- Sponsor's protocol ID
- PEG-01/2007(ELE)
- Status last verified
- Mar 2009
- First submitted
- 24 Mar 2009
- Last updated
- 25 Mar 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Oral PEG 3350 on the Electrolyte Balance in Patient Volunteers With Chronic Constipation:Pharmacokinetic Evaluation
- ClinicalTrials.gov ID
- NCT00868985
- Acronym / sponsor ID
- PEG-01/2007(ELE)
- Conditions
- Chronic Constipation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- NorgineIndustry (pharma, biotech, devices)
- Study start
- Jan 2008
- Primary completion
- Aug 2008 (actual)
- First posted
- 25 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PEG 3350 plus electrolytes | Experimental | Drug: PEG 3350 plus electrolytesPatients were dosed with PEG 3350 with electrolytes |
| PEG 3350 without electrolytes | Experimental | Drug: PEG 3350 without electrolytesPatients were dosed with PEG 3350 without electrolytes |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The subjects written informed consent must be obtained prior to inclusion.
- 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.
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PEG 3350 plus electrolytesEach 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 plus electrolytes |
| PEG 3350 without electrolytesEach patient was treated with PEG 3350 for 10 days at a dose of either one, two or three sachets per day. | Drug | PEG 3350 without electrolytes |
Primary outcome
Electrolyte profile in blood, urine and faeces, serum osmolality and effect on the renin/aldosterone ratio
Time frame: Ten days
1 secondary outcome
Amount of PEG 3350 in plasma, urine and faeces
Time frame: Ten days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hans-Jürgen Gruss, MD study director
Norgine
Rodica Cinca, MD principal investigator
IFE Human Pharmacology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PEG 3350 plus electrolytes and PEG 3350 without electrolytes in people with Chronic Constipation, run by Norgine at 1 site in Romania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Electrolyte profile in blood, urine and faeces, serum osmolality and effect on the renin/aldosterone ratio (time frame: Ten days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2009.