Constipation - FunctionalPhase 3NCT03957668
Efficacy and Safety of PEG 3350 for Treatment of Chronic Constipation
A Phase 3 study testing PEG 3350 and Lactulose in people with Constipation - Functional, run by Fakultas Kedokteran Universitas Indonesia at 3 sites in Indonesia.
Trial summary
The aim of this study is to determine the efficacy and safety of PEG 3350 (polyethylene glycol 3350) for short-term treatment of chronic constipation in adults. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Constipation - Functional
- What is being tested?
- PEG 3350 and Lactulose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 3 sitesIndonesia
- Study dates
- 7 Dec 2019to 31 Oct 2020
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females aged ≥ 18 years.
- Body Mass Index (BMI) ≥ 18.5
- Organic bowel disease will be ruled out by Fecal Immunochemical Test (FIT) and/or colonoscopy.
- Must have ≤ 2 bowel movements during a 7-day qualification period.
- In otherwise good health as judged by a physical examination and laboratory testing.
- Not taking medications known to affect bowel function in one week before study.
- Willing to participate in the study by signing the informed consent.
Who cannot join
- Hypersensitive to the study medication.
- obstructive ileus.
- Irritable bowel syndrome (IBS) or inflammatory bowel disease (IBD)
Trial locations and contacts
3 sites in 1 country.
Indonesia3 sites
Puskesmas Kelurahan Petamburan
Jakarta, DKI Jakarta, 10260
RSUPN dr. Cipto Mangunkusumo (Cipto Mangunkusumo Hospital)
Jakarta, DKI Jakarta, 10430
Puskesmas Kelurahan Paseban
Jakarta, DKI Jakarta, 10440
About this study
The aim of this study is to determine the efficacy and safety of PEG 3350 (polyethylene glycol 3350) for short-term treatment of chronic constipation in adults.
- Conditions
- Constipation - Functional
- Being tested
- PEG 3350, Lactulose
- Keywords
- PEG 3350, Constipation
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEG 3350Drug
PEG 3350 17 g once daily for 14 days
LactuloseDrug
Lactulose 10 g once daily for 14 days
| Study group | Role | What they receive |
|---|---|---|
| PEG 3350 | Experimental | The content of each sachet of PEG 3350 (17 g powder) is dissolved in 240 mL of water, drink it once daily at bedtime, for a duration of 14 days. Receives: Drug: PEG 3350 |
| Lactulax | Active comparator | 15 ml of Lactulax syrup (containing 10 g of lactulose) is drunk with 240 ml of water once daily at bedtime, for a duration of 14 days Receives: Drug: Lactulose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of number of bowel movements at 1 week
An increase in the number of bowel movements (defecation) per 7-day period indicates a positive result.
Measured: 7 days
Change of number of bowel movements at 2 weeks
An increase in the number of bowel movements (defecation) per 7-day period indicates a positive result.
Measured: 14 days
Secondary outcomes (4)
Symptom scores at 1 week
- Stool consistency: 0 = hard, 1 = firm, 2 = soft, 3 = loose, 4 = watery (by anamnesis - visual comparison)
- Stool passage: 0 = strain, 1 = easy, 2 = loss of control (by anamnesis)
- Cramping and rectal irritation associated with each bowel movement: 0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = have to discontinue (by anamnesis)
- Flatus: 0 = none, 1 = moderate, 2 = occasional, 3 = frequent, 4 = very frequent
Measured: 7 days
Symptom scores at 2 weeks
- Stool consistency: 0 = hard, 1 = firm, 2 = soft, 3 = loose, 4 = watery (by anamnesis - visual comparison)
- Stool passage: 0 = strain, 1 = easy, 2 = loss of control (by anamnesis)
- Cramping and rectal irritation associated with each bowel movement: 0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = have to discontinue (by anamnesis)
- Flatus: 0 = none, 1 = moderate, 2 = occasional, 3 = frequent, 4 = very frequent
Measured: 14 days
Overall rating of effectiveness at 1 week
Effective: patients with ≥ 3 bowel movements per 7-day period
Measured: 7 days
Overall rating of effectiveness at 2 weeks
Effective: patients with ≥ 3 bowel movements per 7-day period
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2019
- Study start7 Dec 2019
- Primary completion30 Sep 2020
- Study completion31 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Constipation - FunctionalStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 184 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fakultas Kedokteran Universitas Indonesia
- Sponsor type
- University, hospital or other
- Collaborators
- PT Meiji Indonesia
- Responsible party
- Principal investigator, Murdani Abdullah, Fakultas Kedokteran Universitas Indonesia
- Investigators
- Murdani Abdulah, Principal investigator, Fakultas Kedokteran Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03957668
- Sponsor's protocol ID
- 19-04-0392
- Status last verified
- Oct 2020
- First submitted
- 10 May 2019
- Last updated
- 20 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of PEG 3350 for Treatment of Chronic Constipation
- ClinicalTrials.gov ID
- NCT03957668
- Acronym / sponsor ID
- 19-04-0392
- Conditions
- Constipation - Functional
- Keywords
- PEG 3350, Constipation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 184 participants (estimated)
- Lead sponsor
- Fakultas Kedokteran Universitas IndonesiaUniversity, hospital or other
- Collaborators
- PT Meiji Indonesia
- Study start
- 7 Dec 2019 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 31 Oct 2020 (estimated)
- First posted
- 21 May 2019 (actual)
- 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 aim of this study is to determine the efficacy and safety of PEG 3350 (polyethylene glycol 3350) for short-term treatment of chronic constipation in adults.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PEG 3350 | Experimental | Drug: PEG 3350The content of each sachet of PEG 3350 (17 g powder) is dissolved in 240 mL of water, drink it once daily at bedtime, for a duration of 14 days. |
| Lactulax | Active comparator | Drug: Lactulose15 ml of Lactulax syrup (containing 10 g of lactulose) is drunk with 240 ml of water once daily at bedtime, for a duration of 14 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Males and females aged ≥ 18 years.
- Body Mass Index (BMI) ≥ 18.5
- Organic bowel disease will be ruled out by Fecal Immunochemical Test (FIT) and/or colonoscopy.
- Must have ≤ 2 bowel movements during a 7-day qualification period.
- In otherwise good health as judged by a physical examination and laboratory testing.
Key exclusion criteria (3 listed)
- Hypersensitive to the study medication.
- obstructive ileus.
- Irritable bowel syndrome (IBS) or inflammatory bowel disease (IBD)
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 3350PEG 3350 17 g once daily for 14 days | Drug | PEG 3350 |
| LactuloseLactulose 10 g once daily for 14 days | Drug | Lactulax |
Primary outcome
Change of number of bowel movements at 1 week
Time frame: 7 days
An increase in the number of bowel movements (defecation) per 7-day period indicates a positive result.
Change of number of bowel movements at 2 weeks
Time frame: 14 days
An increase in the number of bowel movements (defecation) per 7-day period indicates a positive result.
4 secondary outcomes
Symptom scores at 1 week
Time frame: 7 days
Symptom scores at 2 weeks
Time frame: 14 days
Overall rating of effectiveness at 1 week
Time frame: 7 days
Overall rating of effectiveness at 2 weeks
Time frame: 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2020.
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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.
Murdani Abdulah principal investigator
Fakultas Kedokteran Universitas Indonesia
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing PEG 3350 and Lactulose in people with Constipation - Functional, run by Fakultas Kedokteran Universitas Indonesia at 3 sites in Indonesia.
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 7 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 20 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Indonesia. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Change of number of bowel movements at 1 week (time frame: 7 days). The study lists 2 primary outcomes in all. 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 20 Oct 2020.