Infantile ColicPhase 1NCT00655083
A Phase I Study to Evaluate the Oral Absorption of Nepadutant in Infants
A Phase 1 study testing Nepadutant in people with Infantile Colic and Infantile Functional Gastrointestinal Disorders, run by Menarini Group at 3 sites in United States.
Trial summary
The purpose of the study is to evaluate the gastrointestinal absorption of nepadutant after single dose as oral solution (and the effect of age on its oral absorption) in infants. Oral absorption is evaluated through the drug recovery in urine. Read more about this study
- Who is it for?
- Ages 6 to 24 weeks
- Conditions the study is for
- Infantile Colic, Infantile Functional Gastrointestinal Disorders
- What is being tested?
- Nepadutant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 3 sitesUnited States
- Study dates
- Mar 2008to May 2009
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 6 to 24 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Subjects will be eligible for inclusion in the study if they meet all of the following criteria:
- Infants with a history consistent with a diagnosis of colic or other functional gastrointestinal disorders
- Age >6 weeks and < 24 weeks
- At least 44 weeks post-conceptual age at enrolment
- Normal growth
- Informed consent by parents (one or both) or legal guardian
- Caregiver available to be trained in collection and storage of used diapers
- Caregiver available to record feeding episodes and defecations on the diary
Who cannot join
- Subjects will be excluded from the study if they meet any of the following criteria:
- Clinical evidence of major cardiovascular, respiratory, renal, hepatic, endocrine, metabolic, gastrointestinal (excluding infantile colic and other functional gastrointestinal disorders, unless associated to symptoms which are likely to interfere with drug absorption, e.g. frequent vomiting), haematological, severe dermatological or neurological pathology or other diseases;
- Previous major surgery or blood loss
- Intake of antimuscarinic drugs, simethicone, or dimethicone 24 hours before study treatment administration.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Rainbow Babies and Children's Hospital
Cleveland, Ohio, 44106
Arkansas Children's Hospital
Little Rock, Arkansas, 72202
Kosair Charities Pediatric Clinical Rsearch Unit University of Louisville
Louisville, Kentucky, 40202
About this study
Official title: Pilot Study to Evaluate the Oral Absorption, Safety, and Tolerability of Nepadutant Administered as Single Oral Doses to Infants With Colic and Other Functional Gastrointestinal Disorders
The purpose of the study is to evaluate the gastrointestinal absorption of nepadutant after single dose as oral solution (and the effect of age on its oral absorption) in infants. Oral absorption is evaluated through the drug recovery in urine.
Read the detailed description
This trial aims to evaluate the oral adsorption of nepadutant (0.1 or 0.5 mg/Kg given as one single dose as oral solution) in infants divided in three age strata (from 6 to 24 weeks old). Oral absorption is evaluated by measuring the amount of nepadutant in the urine output collected during the 24 hours after oral administration with special diapers.
Safety and tolerability of the drug will be evaluated by monitoring any changes in signs/symptoms at medical examination and vital signs during the fist 4 hours post-dose in the Hospital site and then by the parents at home up to 24 hours and 1 week post nepadutant administration.
- Being tested
- Nepadutant
- Keywords
- Infantile colic, Abdominal Cramps, Colicky Pain, Functional gastrointestinal disorders
- Medical subject headings
- Colic, Abdominal Pain, Gastrointestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NepadutantDrug
0.1 mg/Kg as one single oral dose divided in three age strata (from 6 to 24 weeks old)
NepadutantDrug
0.5 mg/Kg as one single oral dose divided in three age strata (from 6 to 24 weeks old)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Nepadutant 0.1 mg/kg Receives: Drug: Nepadutant |
| 2 | Experimental | Nepadutant 0.5 mg/kg Receives: Drug: Nepadutant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Drug Concentration Measurement in the Urine Collected by Diapers Along 24 Hours Post Dose and One Week After Dose in All Treated Infants and by Age and Dose Subgroups.
Nepadutant was measured in the 24-h urine collection post both doses (0.1 and 0.5 mg/kg dose), in the age strata 6-<12 and 12-<18 weeks, using urinary collection/extraction from pre-weighed special fiber based diapers.
Measured: 24 hours
Drug Concentration Measurement in the Urine Collected by Diapers Along 24 Hours Post Dose and One Week After Dose in All Treated Infants and by Age and Dose Subgroups.
Nepadutant was measured in the 24-h urine collection post both doses (0.1 and 0.5 mg/kg dose), in the age stratum 18-24 weeks, using urinary collection/extraction from pre-weighed special fiber based diapers.
Measured: 24 hours
Secondary outcomes (2)
Number of Adverse Events After Administration of Single Oral Doses up to 0.5 mg/kg of Nepadutant in Infants.
Number of adverse events (AE) reported by dose and age stratum 6-<12 and 12-<18 weeks.
Measured: one week
Number of Adverse Events After Administration of Single Oral Doses up to 0.5 mg/kg of Nepadutant in Infants.
Number of adverse events (AE) reported by dose and age stratum 18-24 weeks.
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2008 (estimated)
- Study startMar 2008
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Infantile ColicStudies 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
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Menarini Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeffrey L Blumer, MD, PHD, Study chair, Rainbow Babies and Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00655083
- Sponsor's protocol ID
- NIC 02
- Other IDs
- Oral absorption, of Nepadutant in Infants
- Status last verified
- Oct 2011
- First submitted
- 3 Apr 2008
- Last updated
- 17 Oct 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Evaluate the Oral Absorption, Safety, and Tolerability of Nepadutant Administered as Single Oral Doses to Infants With Colic and Other Functional Gastrointestinal Disorders
- ClinicalTrials.gov ID
- NCT00655083
- Acronym / sponsor ID
- NIC 02
- Keywords
- Infantile colic, Abdominal Cramps, Colicky Pain, Functional gastrointestinal disorders
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Menarini GroupIndustry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 9 Apr 2008 (estimated)
- Results
- Posted 25 Aug 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to evaluate the gastrointestinal absorption of nepadutant after single dose as oral solution (and the effect of age on its oral absorption) in infants. Oral absorption is evaluated through the drug recovery in urine.
Detailed description
This trial aims to evaluate the oral adsorption of nepadutant (0.1 or 0.5 mg/Kg given as one single dose as oral solution) in infants divided in three age strata (from 6 to 24 weeks old). Oral absorption is evaluated by measuring the amount of nepadutant in the urine output collected during the 24 hours after oral administration with special diapers.
Safety and tolerability of the drug will be evaluated by monitoring any changes in signs/symptoms at medical examination and vital signs during the fist 4 hours post-dose in the Hospital site and then by the parents at home up to 24 hours and 1 week post nepadutant administration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: NepadutantNepadutant 0.1 mg/kg |
| 2 | Experimental | Drug: NepadutantNepadutant 0.5 mg/kg |
Who may qualify
- Ages
- 6 to 24 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Subjects will be eligible for inclusion in the study if they meet all of the following criteria:
- Infants with a history consistent with a diagnosis of colic or other functional gastrointestinal disorders
- Age >6 weeks and < 24 weeks
- At least 44 weeks post-conceptual age at enrolment
- Normal growth
Key exclusion criteria (4 listed)
- Clinical evidence of major cardiovascular, respiratory, renal, hepatic, endocrine, metabolic, gastrointestinal (excluding infantile colic and other functional gastrointestinal disorders, unless associated to symptoms which are likely to interfere with drug absorption, e.g. frequent vomiting), haematological, severe dermatological or neurological pathology or other diseases;
- Previous major surgery or blood loss
- Intake of antimuscarinic drugs, simethicone, or dimethicone 24 hours before study treatment administration.
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 |
|---|---|---|
| Nepadutant0.1 mg/Kg as one single oral dose divided in three age strata (from 6 to 24 weeks old) | Drug | 1 |
| Nepadutant0.5 mg/Kg as one single oral dose divided in three age strata (from 6 to 24 weeks old) | Drug | 2 |
Primary outcome
Drug Concentration Measurement in the Urine Collected by Diapers Along 24 Hours Post Dose and One Week After Dose in All Treated Infants and by Age and Dose Subgroups.
Time frame: 24 hours
Nepadutant was measured in the 24-h urine collection post both doses (0.1 and 0.5 mg/kg dose), in the age strata 6-<12 and 12-<18 weeks, using urinary collection/extraction from pre-weighed special fiber based diapers.
Drug Concentration Measurement in the Urine Collected by Diapers Along 24 Hours Post Dose and One Week After Dose in All Treated Infants and by Age and Dose Subgroups.
Time frame: 24 hours
Nepadutant was measured in the 24-h urine collection post both doses (0.1 and 0.5 mg/kg dose), in the age stratum 18-24 weeks, using urinary collection/extraction from pre-weighed special fiber based diapers.
2 secondary outcomes
Number of Adverse Events After Administration of Single Oral Doses up to 0.5 mg/kg of Nepadutant in Infants.
Time frame: one week
Number of Adverse Events After Administration of Single Oral Doses up to 0.5 mg/kg of Nepadutant in Infants.
Time frame: one week
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Jeffrey L Blumer, MD, PHD study chair
Rainbow Babies and Children's Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Nepadutant in people with Infantile Colic and Infantile Functional Gastrointestinal Disorders, run by Menarini Group at 3 sites in United States.
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 8 inclusion and 4 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 17 Oct 2011. 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 United States. 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?
Yes. Results are posted in the registry (first posted 25 Aug 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Drug Concentration Measurement in the Urine Collected by Diapers Along 24 Hours Post Dose and One Week After Dose in All Treated Infants and by Age and Dose Subgroups. (time frame: 24 hours). 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 17 Oct 2011.