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NCT01107236 · ClinicalTrials.gov registry record · Phase 2
Study to Evaluate Efficacy and Safety of IW-6118 in Patients Undergoing Third Molar Extraction
A Phase 2 study of Healthy, sponsored by Ironwood Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 90
- Enrollment target
- 1
- Study location
NCT01107236: Completed Phase 2 study of Healthy, sponsored by Ironwood Pharmaceuticals.
NCT01107236 is a Phase 2 study of Healthy that has completed, run by Ironwood Pharmaceuticals. The registered enrollment target is 90 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (86% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01107236, a Phase 2 study of Healthy, has completed, sponsored by Ironwood Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 90 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to assess the safety of IW-6118 when administered as a single oral dose to patients undergoing third molar extraction. Efficacy will be assessed in an exploratory manner.
Primary Outcome
Adverse events, vital signs, laboratory parameters, and ECGs will be assessed.
Conditions Studied
Interventions
- DRUG Matching Placebo
- DRUG IW-6118
- DRUG Naproxen Sodium
Study Locations (1)
Utah
- Ironwood Investigational Site - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2010-06 |
| Est. Completion | 2010-08 |
| Phase | Phase 2 |
What the finished NCT01107236 record still lists
NCT01107236 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 90 participants, a relatively small participant target, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (86% lower).
The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 3 interventions - of which Matching Placebo is the first listed.
NCT01107236 reports a single indexed study location in Utah.
Frequently Asked Questions
What is clinical trial NCT01107236 about?
NCT01107236 is a clinical study titled "Study to Evaluate Efficacy and Safety of IW-6118 in Patients Undergoing Third Molar Extraction". The purpose of this study is to assess the safety of IW-6118 when administered as a single oral dose to patients undergoing third molar extraction. Efficacy will be assessed in an exploratory manner.
What is the current status of trial NCT01107236?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 90 participants. The study started on 2010-06. Estimated completion is 2010-08.
What conditions does trial NCT01107236 study?
This clinical trial studies the following conditions: Healthy.
What interventions are being tested in trial NCT01107236?
The interventions under investigation include: Matching Placebo (DRUG), IW-6118 (DRUG), Naproxen Sodium (DRUG).
Who is sponsoring clinical trial NCT01107236?
This trial is sponsored by Ironwood Pharmaceuticals, which has 23 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01107236 being conducted?
This trial has 1 study location across Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Healthy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01107236's enrollment target sits among peer trials
90 252nd of 1090 higher than 833 of 1,090 other Healthy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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