Trial · NCT01258153
Preliminary Efficacy and Safety Study of Oral Nepadutant in Infant Colic
NCT01258153, Phase 2, Completed, Menarini Group; results first posted 2015-06-10
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Preliminary Efficacy and Safety Study of Oral Nepadutant in Infant Colic. Trials, record NCT01258153. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01258153
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Preliminary Efficacy and Safety Study of Oral Nepadutant in Infant Colic
- NCT number
- NCT01258153
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 115 participants, actual
- Lead sponsor
- Menarini Group
- Conditions
- Infantile Colic
- Interventions
- Nepadutant oral solution, Nepadutant oral solution, Placebo matching Nepadutant oral solution
- First posted
- 2010-12-10
- Last updated
- 2015-06-10
- Results first posted
- 2015-06-10
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Absolute Change of the Mean Daily Crying and Fussing Time for Three Consecutive Days While on Treatment Versus Baseline. | 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). |
| Secondary | Percentage of 'Responder' Babies at the End of Treatment Period. | baseline and one week | Response is defined as a decrease of at least 50% of crying and fussing time during the last 3 days on treatment vs baseline. |
| Secondary | Absolute Change in the Overall Parental Judgment After the First Dose of Treatment Versus Baseline | 1 day | 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?") |
| Secondary | Absolute Change in the Overall Parental Judgment at the End of Treatment Versus Baseline | 1 week | 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?") |
| Secondary | Absolute Change in the Overall Parental Judgment After Treatment Discontinuation Versus Baseline | 10 days | 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?") |
| Secondary | 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. | up to four weeks | 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. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Absolute Change of the Mean Daily Crying and Fussing Time for Three Consecutive Days While on Treatment Versus Baseline. | Baseline and one week | 112 instead of 113, because 1 subject had no records at baseline and therefore the outcome could not be measured | Minutes | MEAN |
| SECONDARY | Percentage of 'Responder' Babies at the End of Treatment Period. | baseline and one week | 112 instead of 113, because 1 subject had no records at baseline and therefore the outcome could not be measured | Responders Rate (% of responders babies) | NUMBER |
| SECONDARY | Absolute Change in the Overall Parental Judgment After the First Dose of Treatment Versus Baseline | 1 day | ITT - defined as the safety population randomised with at least 24h diary recording post 1st dose of study treatment | Score range 0-5 | MEAN |
| SECONDARY | Absolute Change in the Overall Parental Judgment at the End of Treatment Versus Baseline | 1 week | ITT - defined as the safety population randomised with at least 24h diary recording post 1st dose of study treatment | Score range 0-5 | MEAN |
| SECONDARY | Absolute Change in the Overall Parental Judgment After Treatment Discontinuation Versus Baseline | 10 days | ITT - defined as the safety population randomised with at least 24h diary recording post 1st dose of study treatment | Score range 0-5 | MEAN |
| SECONDARY | 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. | up to four weeks | All patients receiving the study drug (114) | Adverse events | NUMBER |
Source ClinicalTrials.gov
Results by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Absolute Change of the Mean Daily Crying and Fussing Time for Three Consecutive Days While on Treatment Versus Baseline. | Nepadutant Low Dose | Baseline | 284.57 | Standard Deviation 89.298 | Minutes |
| Absolute Change of the Mean Daily Crying and Fussing Time for Three Consecutive Days While on Treatment Versus Baseline. | Nepadutant High Dose | Baseline | 273.6 | Standard Deviation 86.356 | Minutes |
| Absolute Change of the Mean Daily Crying and Fussing Time for Three Consecutive Days While on Treatment Versus Baseline. | Placebo | Baseline | 283.91 | Standard Deviation 80.201 | Minutes |
| Absolute Change of the Mean Daily Crying and Fussing Time for Three Consecutive Days While on Treatment Versus Baseline. | Nepadutant Low Dose | End of Treatment | 185.8 | Standard Deviation 100.97 | Minutes |
| Absolute Change of the Mean Daily Crying and Fussing Time for Three Consecutive Days While on Treatment Versus Baseline. | Nepadutant High Dose | End of Treatment | 154.4 | Standard Deviation 102 | Minutes |
| Absolute Change of the Mean Daily Crying and Fussing Time for Three Consecutive Days While on Treatment Versus Baseline. | Placebo | End of Treatment | 192.7 | Standard Deviation 85.41 | Minutes |
| Absolute Change of the Mean Daily Crying and Fussing Time for Three Consecutive Days While on Treatment Versus Baseline. | Nepadutant Low Dose | Change | -96.9 | Standard Deviation 74.12 | Minutes |
| Absolute Change of the Mean Daily Crying and Fussing Time for Three Consecutive Days While on Treatment Versus Baseline. | Nepadutant High Dose | Change | -119.2 | Standard Deviation 97.13 | Minutes |
| Absolute Change of the Mean Daily Crying and Fussing Time for Three Consecutive Days While on Treatment Versus Baseline. | Placebo | Change | -91.2 | Standard Deviation 76.2 | Minutes |
| Percentage of 'Responder' Babies at the End of Treatment Period. | Nepadutant Low Dose | 36.8 | Responders Rate (% of responders babies) |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Nepadutant Low Dose | 40 | |
| Overall Study | STARTED | Nepadutant High Dose | 38 | |
| Overall Study | STARTED | Placebo | 37 | |
| Overall Study | COMPLETED | Nepadutant Low Dose | 39 | |
| Overall Study | COMPLETED | Nepadutant High Dose | 37 | |
| Overall Study | COMPLETED | Placebo | 36 | |
| Overall Study | NOT COMPLETED | Nepadutant Low Dose | 1 | |
| Overall Study | NOT COMPLETED | Nepadutant High Dose | 1 | |
| Overall Study | NOT COMPLETED | Placebo | 1 |
Source ClinicalTrials.gov
Adverse events57
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Nepadutant Low Dose | 1 | 40 | |
| other | Anaemia | Blood and lymphatic system disorders | Nepadutant High Dose | 0 | 38 | |
| other | Anaemia | Blood and lymphatic system disorders | Placebo | 0 | 36 | |
| other | Aphthous stomatitis | Gastrointestinal disorders | Nepadutant Low Dose | 1 | 40 | |
| other | Aphthous stomatitis | Gastrointestinal disorders | Nepadutant High Dose | 0 | 38 | |
| other | Aphthous stomatitis | Gastrointestinal disorders | Placebo | 0 | 36 | |
| other | Diarrhoea | Gastrointestinal disorders | Nepadutant Low Dose | 0 | 40 | |
| other | Diarrhoea | Gastrointestinal disorders | Nepadutant High Dose | 0 | 38 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 1 | 36 | |
| other | Frequent bowel movements | Gastrointestinal disorders | Nepadutant Low Dose | 1 | 40 |
1 to 10 of 57Source ClinicalTrials.gov
See all 57 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Nepadutant Low Dose | ||
| Total, all-cause mortality | Nepadutant High Dose | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Nepadutant Low Dose | 9 | 40 |
| Total, other adverse events | Nepadutant High Dose | 6 | 38 |
| Total, other adverse events | Placebo | 5 | 36 |
| Total, serious adverse events | Nepadutant Low Dose | 0 | 40 |
| Total, serious adverse events | Nepadutant High Dose | 1 | 38 |
| Total, serious adverse events | Placebo | 0 | 36 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01258153
GET https://conductscience.org/api/trials/v1/NCT01258153/results?page=2