Clinical EfficacyPhase 3NCT05144295
Lubiprostone for Functional Constipation in the Under 18 Years Patients
A Phase 3 study testing Lubiprostone Pill, Lactulose Oral Liquid Product and Bisacodyl 5 MG in people with Clinical Efficacy and Treatment Efficacy, run by Alexandria University at 2 sites in Egypt.
Trial summary
The investigators will enroll subjects 8 - < 18 years of age, fulfilling Rome IV criteria for functional constipation. Participants will be randomly assigned to either Lubiprostone treatment (study group), or the control group (will receive either lactulose or Bisacodyl tablets). safety and efficacy will be assessed. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Clinical Efficacy, Treatment Efficacy, Drug Side Effect
- What is being tested?
- Lubiprostone Pill, Lactulose Oral Liquid Product and Bisacodyl 5 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 274 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Jan 2022to 1 Nov 2022
- 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 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients 8 - < 18 years of age who have a confirmed diagnosis of Pediatric functional constipation according to the Rome IV criteria, who give written informed consent personally or from their legal guardians.
- Discontinuation of any medication affecting gastrointestinal (GI) motility at least 2 weeks before starting the treatment allocation.
- Patient's daily diary that indicates an average of < 3 weekly spontaneous bowel movements (SBMs), with ≥ 25% of SBMs involving at least some straining and/or a 5-point modified Bristol Stool Form Scale type 1 or 2.
- Patients who completed the study protocol.
Who cannot join
- If the patient's constipation is attributed to any of the following: physical, mental, or cognitive illness, inflammatory bowel disease, medication, anatomical, neurological, endocrine, or metabolic factors.
- If the patient is a candidate for or underwent abdominal surgery, or has any condition other than constipation that could affect gastrointestinal motility or defecation.
- Patients suffering from Hirschsprung's disease.
- Patients experiencing any alarming signs e.g. unexplained significant weight loss.
- Untreated fecal impaction at the time of enrollment.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Alexandria Main University Hospital
Alexandria, 21521
Faculty of Medicine
Alexandria, 21521
About this study
Official title: Lubiprostone for the Treatment of Functional Constipation in the Under 18 Years Patients: A Randomized, Controlled Trial.
The investigators will enroll subjects 8 - < 18 years of age, fulfilling Rome IV criteria for functional constipation.
Participants will be randomly assigned to either Lubiprostone treatment (study group), or the control group (will receive either lactulose or Bisacodyl tablets).
safety and efficacy will be assessed.
Read the detailed description
The investigators will enroll 274 subjects who will be randomly divided equally into interventional and control groups.
Participants and their parents/legal guardians will be instructed to administer the doses at least 5 hours apart with meals and a large volume of fluid.
The control group will receive lactulose 1 mL/kg, once or twice daily (maximum 60 mL/day or Bisacodyl tablet (5 mg/tablet) in a dose of 2 tab/day for < 12 years or 3 tab/day for > 12 years.
Both arms will receive the treatment for 12 weeks followed by 4 weeks follow-up after the end of treatment (week 16).
Participants (and their guardians) will be instructed to regularly document the number of spontaneous bowel motions/week and to define their Bristol chart category for every bowel motion. In addition, the participants will be encouraged to contact the trial team if any adverse events appeared. This is in addition to regular visits at 0, 2, 8, 12 weeks for assessment of safety (efficacy will be assessed at weeks 8, 12, and 16).
- Conditions
- Clinical Efficacy, Treatment Efficacy, Drug Side Effect
- Being tested
- Lubiprostone Pill, Lactulose Oral Liquid Product, Bisacodyl 5 MG, Sodium Picosulfate
- Keywords
- Lubiprostone, Functional constipation, Adolescent, Children, Spontaneous Bowel Motions, Drug safety
- Medical subject headings
- Drug-Related Side Effects and Adverse Reactions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lubiprostone PillDrug
Also called Amiprostone 8 mcg caps, Amiprostone 24 mcg caps, Lubicont 8 mcg caps
Oral pills for constipation (Lubiprostone) will be given in a dose range from 24 mcg once daily to 24 mcg twice daily according to the participant weight.
Lactulose Oral Liquid ProductDrug
Also called Lactulose OR Duphalac
Lactulose " Lactulose, or Duphalac syrup" at a dose of 1 ml/kg once or twice daily (maximum 60 mL/day)
Bisacodyl 5 MGDrug
Also called Bisacodyl 5 mg tablets
Bisacodyl tablet (5 mg/tablet) in a dose of 2 tab/day for < 12 years or 3 tab/day for > 12 years
Sodium PicosulfateDrug
Also called Bisadyl 0.75% drops
Sodium Picosulfate 0.75% drops in a daily dose of 2.5-20 mg/day
| Study group | Role | What they receive |
|---|---|---|
| Investigational Arm | Experimental | * Patients will receive lubiprostone capsules (Amiprostone 8 and 24 mcg, or Lubicont 8 mcg)
* Patients weighing <50 kg will be given lubiprostone at doses of 8 mcg/8 hours.
* Patients weighing ≥ 50 kg will be given lubiprostone at doses of 24 mcg BID.
* Patients and their parents/legal guardians will be instructed to administer the doses at least 5 hours apart with meals and a large volume of fluid. Receives: Drug: Lubiprostone Pill |
| Control Arm | Active comparator | Subjects will receive the conventional therapy (one or a combination of the following):
* Lactulose " Lactulose, or Duphalac syrup" at a dose of 1 ml/kg once or twice daily (maximum 60 mL/day),
* Bisacodyl tablets " Bisacodyl 5 mg/tablet" in a dose of 2 tab/day for < 12 years or 3 tab/day for > 12 years, or
* Sodium Picosulfate 0.75% drops (Picolax drops) in a daily dose of 2.5-20 mg/day. Receives: Drug: Lactulose Oral Liquid Product; Drug: Bisacodyl 5 MG; Drug: Sodium Picosulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome
Spontaneous bowel motions (SBM) ≥ 1 SBM/week increase in the frequency compared with baseline, and ≥ 3 SBMs/week for at least 8 weeks, including the last 4 study weeks and the 4 weeks of follow-up.
Measured: At study week 16.
Secondary outcomes (4)
Early spontaneous bowel motions
Number of participants who experienced first SBM within 48 hours after dose initiation.
Measured: First 48 hours after first drug dose.
First dose response time
The time between first dose of treatment and the first SBM.
Measured: 1st week of treatment
Number of Spontaneous Bowel Motions/Week.
Number of Spontaneous Bowel Motions/Week.
Measured: At study week Week 8, 12.
Responders rate
Responders rate at week 8, 12, 16.
Measured: At study week Week 8, 12, 16.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2021
- Study start1 Jan 2022
- Primary completion25 Aug 2022
- Study completion1 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinical EfficacyStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- 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
- Model description
- Patients assigned to lubiprostone will receive a dose based on their weight at the time of enrollment. patients weighing \<50 kg and ≥ 50 kg will be given lubiprostone at doses of 8 mg TID and 24 mg BID, respectively. Patients and their parents/legal guardians will be instructed to administer the doses at least 5 hours apart with meals and large volume of fluid. The control group will receive the conventional therapy (lactulose 1 mL/kg, once or twice daily (maximum 60 mL/day), or Bisacodyl tablet (5 mg/tablet) in a dose of 2 tab/day for \< 12 years or 3 tab/day for \> 12 years. Both arms will receive the treatment for 12 weeks followed by 4 weeks follow-up after the end of treatment (week 16).
- Masking
- None (open label)
- Enrolment
- 274 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sameh A. Lashen, Alexandria University
- Investigators
- Sameh A. Lashen, MD (Ph.D.), Principal investigator, Faculty of Medicine, Alexandria University - Alexandria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05144295
- Sponsor's protocol ID
- 0305299
- Status last verified
- Nov 2022
- First submitted
- 22 Nov 2021
- Last updated
- 15 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: patient personal and identification data will not be available for sharing
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lubiprostone for the Treatment of Functional Constipation in the Under 18 Years Patients: A Randomized, Controlled Trial.
- ClinicalTrials.gov ID
- NCT05144295
- Acronym / sponsor ID
- 0305299
- Conditions
- Clinical Efficacy, Treatment Efficacy, Drug Side Effect
- Keywords
- Lubiprostone, Functional constipation, Adolescent, Children, Spontaneous Bowel Motions, Drug safety
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 274 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 25 Aug 2022 (actual)
- Study completion
- 1 Nov 2022 (actual)
- First posted
- 3 Dec 2021 (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 investigators will enroll subjects 8 - < 18 years of age, fulfilling Rome IV criteria for functional constipation.
Participants will be randomly assigned to either Lubiprostone treatment (study group), or the control group (will receive either lactulose or Bisacodyl tablets).
safety and efficacy will be assessed.
Detailed description
The investigators will enroll 274 subjects who will be randomly divided equally into interventional and control groups.
Participants and their parents/legal guardians will be instructed to administer the doses at least 5 hours apart with meals and a large volume of fluid.
The control group will receive lactulose 1 mL/kg, once or twice daily (maximum 60 mL/day or Bisacodyl tablet (5 mg/tablet) in a dose of 2 tab/day for < 12 years or 3 tab/day for > 12 years.
Both arms will receive the treatment for 12 weeks followed by 4 weeks follow-up after the end of treatment (week 16).
Participants (and their guardians) will be instructed to regularly document the number of spontaneous bowel motions/week and to define their Bristol chart category for every bowel motion. In addition, the participants will be encouraged to contact the trial team if any adverse events appeared. This is in addition to regular visits at 0, 2, 8, 12 weeks for assessment of safety (efficacy will be assessed at weeks 8, 12, and 16).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients assigned to lubiprostone will receive a dose based on their weight at the time of enrollment. patients weighing <50 kg and ≥ 50 kg will be given lubiprostone at doses of 8 mg TID and 24 mg BID, respectively. Patients and their parents/legal guardians will be instructed to administer the doses at least 5 hours apart with meals and large volume of fluid. The control group will receive the conventional therapy (lactulose 1 mL/kg, once or twice daily (maximum 60 mL/day), or Bisacodyl tablet (5 mg/tablet) in a dose of 2 tab/day for < 12 years or 3 tab/day for > 12 years. Both arms will receive the treatment for 12 weeks followed by 4 weeks follow-up after the end of treatment (week 16).
| Arm | Type | Receives |
|---|---|---|
| Investigational Arm | Experimental | Drug: Lubiprostone Pill* Patients will receive lubiprostone capsules (Amiprostone 8 and 24 mcg, or Lubicont 8 mcg) * Patients weighing <50 kg will be given lubiprostone at doses of 8 mcg/8 hours. * Patients weighing ≥ 50 kg will be given lubiprostone at doses of 24 mcg BID. * Patients and their parents/legal guardians will be instructed to administer the doses at least 5 hours apart with meals and a large volume of fluid. |
| Control Arm | Active comparator | Drug: Lactulose Oral Liquid Product, Drug: Bisacodyl 5 MG, Drug: Sodium PicosulfateSubjects will receive the conventional therapy (one or a combination of the following): * Lactulose " Lactulose, or Duphalac syrup" at a dose of 1 ml/kg once or twice daily (maximum 60 mL/day), * Bisacodyl tablets " Bisacodyl 5 mg/tablet" in a dose of 2 tab/day for < 12 years or 3 tab/day for > 12 years, or * Sodium Picosulfate 0.75% drops (Picolax drops) in a daily dose of 2.5-20 mg/day. |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Patients 8 - < 18 years of age who have a confirmed diagnosis of Pediatric functional constipation according to the Rome IV criteria, who give written informed consent personally or from their legal guardians.
- Discontinuation of any medication affecting gastrointestinal (GI) motility at least 2 weeks before starting the treatment allocation.
- Patient's daily diary that indicates an average of < 3 weekly spontaneous bowel movements (SBMs), with ≥ 25% of SBMs involving at least some straining and/or a 5-point modified Bristol Stool Form Scale type 1 or 2.
- Patients who completed the study protocol.
Key exclusion criteria (5 listed)
- If the patient's constipation is attributed to any of the following: physical, mental, or cognitive illness, inflammatory bowel disease, medication, anatomical, neurological, endocrine, or metabolic factors.
- If the patient is a candidate for or underwent abdominal surgery, or has any condition other than constipation that could affect gastrointestinal motility or defecation.
- Patients suffering from Hirschsprung's disease.
- Patients experiencing any alarming signs e.g. unexplained significant weight loss.
- Untreated fecal impaction at the time of enrollment.
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 |
|---|---|---|
| Lubiprostone PillAlso: Amiprostone 8 mcg caps, Amiprostone 24 mcg caps, Lubicont 8 mcg capsOral pills for constipation (Lubiprostone) will be given in a dose range from 24 mcg once daily to 24 mcg twice daily according to the participant weight. | Drug | Investigational Arm |
| Lactulose Oral Liquid ProductAlso: Lactulose OR DuphalacLactulose " Lactulose, or Duphalac syrup" at a dose of 1 ml/kg once or twice daily (maximum 60 mL/day) | Drug | Control Arm |
| Bisacodyl 5 MGAlso: Bisacodyl 5 mg tabletsBisacodyl tablet (5 mg/tablet) in a dose of 2 tab/day for < 12 years or 3 tab/day for > 12 years | Drug | Control Arm |
| Sodium PicosulfateAlso: Bisadyl 0.75% dropsSodium Picosulfate 0.75% drops in a daily dose of 2.5-20 mg/day | Drug | Control Arm |
Primary outcome
Primary outcome
Time frame: At study week 16.
Spontaneous bowel motions (SBM) ≥ 1 SBM/week increase in the frequency compared with baseline, and ≥ 3 SBMs/week for at least 8 weeks, including the last 4 study weeks and the 4 weeks of follow-up.
4 secondary outcomes
Early spontaneous bowel motions
Time frame: First 48 hours after first drug dose.
First dose response time
Time frame: 1st week of treatment
Number of Spontaneous Bowel Motions/Week.
Time frame: At study week Week 8, 12.
Responders rate
Time frame: At study week Week 8, 12, 16.
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 15 Nov 2022.
- Individual participant dataSharing planned: No. patient personal and identification data will not be available for sharing
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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.
Sameh A. Lashen, MD (Ph.D.) principal investigator
Faculty of Medicine, Alexandria University - Alexandria
2 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 Lubiprostone Pill, Lactulose Oral Liquid Product and Bisacodyl 5 MG in people with Clinical Efficacy and Treatment Efficacy, run by Alexandria University at 2 sites in Egypt.
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 4 inclusion and 5 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 15 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. 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?
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?
Primary outcome (time frame: At study week 16.). 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 15 Nov 2022.