Infantile ColicPhase 2no-cryNCT01258153
Preliminary Efficacy and Safety Study of Oral Nepadutant in Infant Colic
A Phase 2 study testing Nepadutant oral solution in people with Infantile Colic, run by Menarini Group at 9 sites in 4 countries.
Trial summary
This phase IIa study is designed as a multi-centre, multinational, randomised, double-blind, placebo controlled study in three parallel groups, with the aim to evaluate the efficacy and safety of Nepadutant given at two oral doses once daily for seven days in comparison to placebo in the treatment of infantile colic. Read more about this study
- Who is it for?
- Ages 4 to 20 weeks
- Conditions the study is for
- Infantile Colic
- What is being tested?
- Nepadutant oral solution
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 115 participants
- Where
- 9 sitesin 4 countries
- Study dates
- Nov 2010to Mar 2014
- Phase
- Phase 2
- 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 4 to 20 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Healthy infants with diagnosis of infant colic according to the following modified Wessel criterion "paroxysm of irritability, fussing or crying that start and stop without obvious cause for >3h/day, >3 days/week for one week"
- Age > 4 weeks and < 20 weeks
- Infants breast-fed mixed fed or formula fed with a stable dietary regimen
- Normal growth
- History of no adequate response to conventional treatment alternatives which make the infants in need of medical treatment
- Willingness to refrain from use of antimuscarinic drugs, simethicone, dimethicone or antiacids during the study period.
Who cannot join
- Clinical evidence of allergies or other diseases which may cause crying and/or fussiness or may interfere with absorption or clearance of the drug.
- Suspect of gastroesophageal reflux disease (GERD)
- Suspect of cow milk allergy.
Trial locations and contacts
9 sites in 4 countries.
9 sites in 4 countries
Russia6 sites
Federal Scientific Clinical Center of Children Hematology, Oncology and Immunology
Moscow, 117997
Moscow State Healthcare Institution Municipal Pediatric health center № 10
Moscow, 119331
Moscow State Medical University
Moscow, 119991
Federal Scientific Clinical Center of Children Hematology, Oncology and Immunology
Moscow, 123317
St. Petersburg State Pediatric Medical Academy
Saint Petersburg, 194100
St. Petersburg State Institution of Healthcare Municipal Pediatric health center № 35
Saint Petersburg, 199191
Germany1 site
Dr. von Haunersches Kinderspital Ludwig Maximilians Universität München
München, 80337
Poland1 site
Klinika Patologii Noworodkow, Niemowlat I Kardiologii, Dzieciecy Szpital Kliniczny
Lublin, 20-093
Sweden1 site
Pediatrics Department of Clinical sciences Umeå university
Umeå, SE-901 85
About this study
Official title: Double-blind, Randomised, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Oral Administration of Nepadutant in Infant Colic
This phase IIa study is designed as a multi-centre, multinational, randomised, double-blind, placebo controlled study in three parallel groups, with the aim to evaluate the efficacy and safety of Nepadutant given at two oral doses once daily for seven days in comparison to placebo in the treatment of infantile colic.
Read the detailed description
Infant colic is a functional gastrointestinal disorders which affects up to the 30% of the infant population; it is primarily characterised by excessive inconsolable crying starting without any apparent cause and lasting for several hours per day.
Current non pharmacological interventions (e.g. message, restriction in maternal diet in breast-feeding infants) and pharmacological treatments (simethicone, antimuscarinic drugs) are largely unsatisfactory.
In animal models, Nepadutant reverse the exaggerated intestinal motility and sensitivity, induced by different stimuli, without producing inhibitory effects on these functions at baseline, suggesting that Nepadutant could have a therapeutic effect with no interference on physiological gastrointestinal transit.
This phase IIa study is designed to evaluate the efficacy of Nepadutant paediatric oral solution given once daily at two doses in comparison to placebo.
The experimental clinical phase encompasses the following periods:
- Screening period (no study medication) to be done 7 to 4 days prior to randomisation
- Treatment period, lasting seven days with once daily administration
- Post treatment period, lasting seven days A safety follow-up visit will be performed approximately 1 month after the first administered dose.
- Conditions
- Infantile Colic
- Being tested
- Nepadutant oral solution, Placebo matching Nepadutant oral solution
- Keywords
- Infantile Colic, tachykinin antagonist, Nepadutant
- Medical subject headings
- Colic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nepadutant oral solutionDrug
Oral administration once daily for 7 days
Nepadutant oral solutionDrug
Oral administration once daily for 7 days
Placebo matching Nepadutant oral solutionDrug
Oral administration once daily for 7 days
| Study group | Role | What they receive |
|---|---|---|
| Nepadutant Low Dose | Experimental | Not described Receives: Drug: Nepadutant oral solution |
| Nepadutant High Dose | Experimental | Not described Receives: Drug: Nepadutant oral solution |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo matching Nepadutant oral solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute Change of the Mean Daily Crying and Fussing Time for Three Consecutive Days While on Treatment Versus Baseline.
Efficacy assessment to be measured through "baby's day" diary recorded for three consecutive days while on treatment (i.e. starting from 6 pm on Day 4 and continued for 72 hours) vs baseline (i.e. starting from 6 pm on Day -4 until 1st treatment administration).
Measured: Baseline and one week
Secondary outcomes (5)
Percentage of 'Responder' Babies at the End of Treatment Period.
Response is defined as a decrease of at least 50% of crying and fussing time during the last 3 days on treatment vs baseline.
Measured: baseline and one week
Absolute Change in the Overall Parental Judgment After the First Dose of Treatment Versus Baseline
On a daily basis parents expressed an overall judgement on the study treatment effect based on a 6 rate categorical scale from 0 to 5 (where 0 is for "Not at all" and 5 is "Extremely".
The question was "How frustrating to you was your baby's crying today?")
Measured: 1 day
Absolute Change in the Overall Parental Judgment at the End of Treatment Versus Baseline
On a daily basis parents expressed an overall judgement on the study treatment effect based on a 6 rate categorical scale from 0 to 5 (where 0 is for "Not at all" and 5 is "Extremely".
The question was "How frustrating to you was your baby's crying today?")
Measured: 1 week
Absolute Change in the Overall Parental Judgment After Treatment Discontinuation Versus Baseline
On a daily basis parents expressed an overall judgement on the study treatment effect based on a 6 rate categorical scale from 0 to 5 (where 0 is for "Not at all" and 5 is "Extremely".
The question was "How frustrating to you was your baby's crying today?")
Measured: 10 days
Safety and Tolerability Will be Assessed in Terms of Frequency and Severity of AEs as Well as Frequency of Clinically Significant Changes in Physical Examination and Lab Test.
Safety and tolerability will be assessed for the Safety Population (all patients who received the study drug) in terms of frequency and severity of AEs as well as frequency of clinically significant changes in physical examination and lab test.
Measured: up to four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2010 (estimated)
- Study startNov 2010
- Primary completionDec 2013
- Study completionMar 2014
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Menarini Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sibylle Koletzko, MD, Study chair, Dr. v. Haunersches Kinderspital Ludwig Maximilians University D- 80337 München, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01258153
- Sponsor's protocol ID
- NIC-03
- Acronym
- no-cry
- Status last verified
- May 2015
- First submitted
- 9 Dec 2010
- Last updated
- 10 Jun 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind, Randomised, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Oral Administration of Nepadutant in Infant Colic
- ClinicalTrials.gov ID
- NCT01258153
- Acronym / sponsor ID
- no-cry / NIC-03
- Conditions
- Infantile Colic
- Keywords
- Infantile Colic, tachykinin antagonist, Nepadutant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Menarini GroupIndustry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- Dec 2013 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 10 Dec 2010 (estimated)
- Results
- Posted 10 Jun 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase IIa study is designed as a multi-centre, multinational, randomised, double-blind, placebo controlled study in three parallel groups, with the aim to evaluate the efficacy and safety of Nepadutant given at two oral doses once daily for seven days in comparison to placebo in the treatment of infantile colic.
Detailed description
Infant colic is a functional gastrointestinal disorders which affects up to the 30% of the infant population; it is primarily characterised by excessive inconsolable crying starting without any apparent cause and lasting for several hours per day.
Current non pharmacological interventions (e.g. message, restriction in maternal diet in breast-feeding infants) and pharmacological treatments (simethicone, antimuscarinic drugs) are largely unsatisfactory.
In animal models, Nepadutant reverse the exaggerated intestinal motility and sensitivity, induced by different stimuli, without producing inhibitory effects on these functions at baseline, suggesting that Nepadutant could have a therapeutic effect with no interference on physiological gastrointestinal transit.
This phase IIa study is designed to evaluate the efficacy of Nepadutant paediatric oral solution given once daily at two doses in comparison to placebo.
The experimental clinical phase encompasses the following periods:
- Screening period (no study medication) to be done 7 to 4 days prior to randomisation
- Treatment period, lasting seven days with once daily administration
- Post treatment period, lasting seven days A safety follow-up visit will be performed approximately 1 month after the first administered dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Nepadutant Low Dose | Experimental | Drug: Nepadutant oral solution |
| Nepadutant High Dose | Experimental | Drug: Nepadutant oral solution |
| Placebo | Placebo comparator | Drug: Placebo matching Nepadutant oral solution |
Who may qualify
- Ages
- 4 to 20 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Healthy infants with diagnosis of infant colic according to the following modified Wessel criterion "paroxysm of irritability, fussing or crying that start and stop without obvious cause for >3h/day, >3 days/week for one week"
- Age > 4 weeks and < 20 weeks
- Infants breast-fed mixed fed or formula fed with a stable dietary regimen
- Normal growth
- History of no adequate response to conventional treatment alternatives which make the infants in need of medical treatment
Key exclusion criteria (3 listed)
- Clinical evidence of allergies or other diseases which may cause crying and/or fussiness or may interfere with absorption or clearance of the drug.
- Suspect of gastroesophageal reflux disease (GERD)
- Suspect of cow milk allergy.
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 |
|---|---|---|
| Nepadutant oral solutionOral administration once daily for 7 days | Drug | Nepadutant Low Dose |
| Nepadutant oral solutionOral administration once daily for 7 days | Drug | Nepadutant High Dose |
| Placebo matching Nepadutant oral solutionOral administration once daily for 7 days | Drug | Placebo |
Primary outcome
Absolute Change of the Mean Daily Crying and Fussing Time for Three Consecutive Days While on Treatment Versus Baseline.
Time frame: Baseline and one week
Efficacy assessment to be measured through "baby's day" diary recorded for three consecutive days while on treatment (i.e. starting from 6 pm on Day 4 and continued for 72 hours) vs baseline (i.e. starting from 6 pm on Day -4 until 1st treatment administration).
5 secondary outcomes
Percentage of 'Responder' Babies at the End of Treatment Period.
Time frame: baseline and one week
Absolute Change in the Overall Parental Judgment After the First Dose of Treatment Versus Baseline
Time frame: 1 day
Absolute Change in the Overall Parental Judgment at the End of Treatment Versus Baseline
Time frame: 1 week
Absolute Change in the Overall Parental Judgment After Treatment Discontinuation Versus Baseline
Time frame: 10 days
Safety and Tolerability Will be Assessed in Terms of Frequency and Severity of AEs as Well as Frequency of Clinically Significant Changes in Physical Examination and Lab Test.
Time frame: up to four weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2015.
- 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.
Sibylle Koletzko, MD study chair
Dr. v. Haunersches Kinderspital Ludwig Maximilians University D- 80337 München, Germany
9 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nepadutant oral solution in people with Infantile Colic, run by Menarini Group at 9 sites in 4 countries.
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 6 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: finished, as of the sponsor's last update on 10 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Russia, Germany, Poland, Sweden. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 10 Jun 2015). 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?
Absolute Change of the Mean Daily Crying and Fussing Time for Three Consecutive Days While on Treatment Versus Baseline. (time frame: Baseline and one week). 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 10 Jun 2015.