HealthyPhase 2NCT01107236
Study to Evaluate Efficacy and Safety of IW-6118 in Patients Undergoing Third Molar Extraction
A Phase 2 study testing IW-6118 and Naproxen Sodium in people with Healthy, run by Ironwood Pharmaceuticals, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- IW-6118 and Naproxen Sodium
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2010to Aug 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Between 18 and 30 years old at time of screening;
- BMI > 18.5 and < 30.0;
- In overall good health with no clinically-significant laboratory, ECG, or physical exam findings;
- Patient requires two ipsilateral third molar extractions of which one must be a full or partial bony mandibular impaction;
- Women of childbearing potential must have a negative pregnancy test and must agree to use double-barrier contraception;
- Other inclusion criteria per protocol.
Who cannot join
- History of any clinically-significant medical condition;
- Previous usage of prescription, OTC, or investigational drugs as per protocol requirements;
- Inadequate levels of pain to be included in the study;
- Other exclusion criteria per protocol.
Trial locations and contacts
1 site in 1 country.
United States1 site
Ironwood Investigational Site
Salt Lake City, Utah, 84124
About this study
Official title: A Phase 2, Single-center, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group Study of a Single Dose 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.
- Conditions
- Healthy
- Being tested
- IW-6118, Matching Placebo, Naproxen Sodium
- Keywords
- Healthy subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IW-6118Drug
Single dose
Matching PlaceboDrug
Single dose of matching placebo for IW-6118 and/or matching placebo for naproxen sodium
Naproxen SodiumDrug
Single dose
| Study group | Role | What they receive |
|---|---|---|
| IW-6118 | Experimental | Not described Receives: Drug: IW-6118 |
| Placebo | Placebo comparator | Not described Receives: Drug: Matching Placebo |
| Naproxen Sodium | Active comparator | Not described Receives: Drug: Naproxen Sodium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Assessments
Adverse events, vital signs, laboratory parameters, and ECGs will be assessed.
Measured: Duration of the Study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2010 (estimated)
- Study startJun 2010
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ironwood Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01107236
- Sponsor's protocol ID
- ICP-109-201
- Status last verified
- Aug 2022
- First submitted
- 19 Apr 2010
- Last updated
- 11 Aug 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Single-center, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group Study of a Single Dose of IW-6118, in Patients Undergoing Third Molar Extraction
- ClinicalTrials.gov ID
- NCT01107236
- Acronym / sponsor ID
- ICP-109-201
- Conditions
- Healthy
- Keywords
- Healthy subjects
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Ironwood Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 20 Apr 2010 (estimated)
- Results
- Not posted in the source record
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 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.
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 |
|---|---|---|
| IW-6118 | Experimental | Drug: IW-6118 |
| Placebo | Placebo comparator | Drug: Matching Placebo |
| Naproxen Sodium | Active comparator | Drug: Naproxen Sodium |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Between 18 and 30 years old at time of screening;
- BMI > 18.5 and < 30.0;
- In overall good health with no clinically-significant laboratory, ECG, or physical exam findings;
- Patient requires two ipsilateral third molar extractions of which one must be a full or partial bony mandibular impaction;
- Women of childbearing potential must have a negative pregnancy test and must agree to use double-barrier contraception;
Key exclusion criteria (4 listed)
- History of any clinically-significant medical condition;
- Previous usage of prescription, OTC, or investigational drugs as per protocol requirements;
- Inadequate levels of pain to be included in the study;
- Other exclusion criteria per protocol.
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 |
|---|---|---|
| IW-6118Single dose | Drug | IW-6118 |
| Matching PlaceboSingle dose of matching placebo for IW-6118 and/or matching placebo for naproxen sodium | Drug | Placebo |
| Naproxen SodiumSingle dose | Drug | Naproxen Sodium |
Primary outcome
Safety Assessments
Time frame: Duration of the Study
Adverse events, vital signs, laboratory parameters, and ECGs will be assessed.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IW-6118 and Naproxen Sodium in people with Healthy, run by Ironwood Pharmaceuticals, Inc. at 1 site 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 6 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 11 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Safety Assessments (time frame: Duration of the Study). 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 11 Aug 2022.