Trial · NCT03262688
Safety, Tolerability, PK, and Analgesic Effect of INL-001 in Children Following Open Inguinal Hernia Repair
NCT03262688, Phase 3, Unknown, Innocoll
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety, Tolerability, PK, and Analgesic Effect of INL-001 in Children Following Open Inguinal Hernia Repair. Trials, record NCT03262688. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03262688
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety, Tolerability, PK, and Analgesic Effect of INL-001 in Children Following Open Inguinal Hernia Repair
- NCT number
- NCT03262688
- Status
- Unknown
- Phases
- Phase 3
- Enrollment
- 159 participants, estimated
- Lead sponsor
- Innocoll
- Conditions
- Inguinal Hernia, Postoperative Pain
- Interventions
- Bupivacaine HCl collagen-matrix implant, Bupivacaine HCl infiltration
- First posted
- 2017-08-25
- Last updated
- 2021-07-30
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Adverse events | 30 days | Possibly related to bupivacaine toxicity |
| Primary | Blood pressure (systolic/diastolic) | Starting at Time 0 and continuing for 3 hours and then 5, 8, 12, 24, 36, and 48 hours after Time 0 | Signs/symptoms of bupivacaine toxicity |
| Primary | Heart rate | Continuously from Time 0 through 3 hours, and then 5, 8, 12, 24, 36, and 48 hours after Time 0 | Signs/symptoms of bupivacaine toxicity |
| Primary | Respiratory rate | Continuously from Time 0 through 3 hours, and then 5, 8, 12, 24, 36, and 48 hours after Time 0 | Signs/symptoms of bupivacaine toxicity |
| Primary | Body temperature | Through Day 30 | Signs/symptoms of bupivacaine toxicity |
| Primary | 12-lead ECG | 1 day at screening | Screening only |
| Primary | 3-lead ECG | Starting at Time 0 and continuing for at least 3 hours | Signs/symptoms of bupivacaine toxicity |
| Primary | Oxygen saturation levels | Starting at Time 0 and continuing for at least 3 hours | Pulse oximetry |
| Primary | Clinical laboratory testing | 1 day at screening | Collection of blood and urine samples |
| Primary | Wound healing assessments | Assessment on Day 1 through Day 3; follow-up evaluations on Days 7, 15 and 30 | Inspection of surgical wound site for signs of wound infection and dehiscence. |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
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/NCT03262688
GET https://conductscience.org/api/trials/v1/NCT03262688/registered