Urinary CalculiPhase 1NCT00599664
Pharmacokinetic and Safety Study of OMS201 in Subjects Undergoing Ureteroscopic Treatment for Removal of Urinary Tract-Located Stones
A Phase 1 study testing OMS201 in people with Urinary Calculi and Urinary Stones, run by Omeros Corporation at 2 sites in United States.
Trial summary
Evaluate the safety and systemic absorption of OMS201 following exposure during ureteroscopy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Urinary Calculi, Urinary Stones, Urinary Tract Stones
- What is being tested?
- OMS201
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2007to Sep 2008
- Phase
- Phase 1
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is undergoing unilateral ureteroscopic removal of renal collecting system or ureteral stones located in the ureter with a maximum stone diameter of 12 mm, for which general anesthesia will be used.
- Subject's physical examination is within normal limits or examination is clinically non-significant for purposes of the study as determined by the Investigator, and subject is in good general health.
- Subject's laboratory evaluations are within normal limits or evaluations are clinically non-significant as determined by the Investigator.
- Female subject of childbearing potential who is using an effective method of birth control within at least 14 days prior to surgery and has a negative pregnancy test.
- Subject is at minimal risk from anesthesia and is classified according to the American Society of Anesthesiologists Physical Status Classification as either PS-1 or PS-2.
- Subject's body mass index is between 19 and 35, inclusive, based on the Body Mass Index Table.
Who cannot join
- Subject taking a prohibited medication.
- Subject who has had a renal transplant, has a single kidney or has evidence of a compromised renal function as measured by abnormal serum creatinine, as judged by the Investigator, or who has evidence of urinary tract infection, or has prior history of open or laparoscopic surgery, or any history of an ureteral stricture.
- Subject who has congenital anomalies that would engender an increased procedural safety risk such as ureteropelvic junction obstruction resulting in severely dilated renal pelvis, duplicated urinary collecting system, horseshoe kidney or vascular anomalies such as renal arteriovenous fistulas or papillary necrosis.
- Subject has bilateral renal or ureteral stones requiring concurrent ureteroscopic removal.
- Subject with clinically significant hypotension at Screening.
- Subject who has a present condition or history of any clinically significant uncontrolled gastrointestinal, cardiovascular, hepatic, renal, hematological, endocrine, neurological, psychiatric, connective tissue, respiratory or other medical disorder as determined by the Investigator.
- Subject on chronic diuretic use.
- Subject who has taken or used an investigational drug or device within 30 days prior to the day of surgery.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Texas Southwestern
Dallas, Texas, 75390
UC Irvine Medical Center
Orange, California, 92868
About this study
Official title: Double-Blind, Placebo-Controlled, Two-Center, Pharmacokinetic Study Evaluating the Systemic Absorption and Safety of OMS201 in Subjects Undergoing Ureteroscopic Treatment of Unilateral Ureteral- or Renal Collecting System-Located Stones
Evaluate the safety and systemic absorption of OMS201 following exposure during ureteroscopy.
Read the detailed description
OMS201 is being developed to facilitate endoscopy of the ureters and to reduce postoperative discomfort, such as pain, frequency, urgency and/or difficult urination following endoscopic surgery to remove a urinary tract stone.
- Conditions
- Urinary Calculi, Urinary Stones, Urinary Tract Stones
- Being tested
- OMS201, Vehicle
- Keywords
- Urinary Calculi, Urinary Stones, Urinary Tract Stones, Calculi
- Medical subject headings
- Urinary Calculi, Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OMS201Drug
OMS201 irrigation solution during surgery
VehicleDrug
Vehicle irrigation solution during surgery
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Drug Receives: Drug: OMS201 |
| 2 | Placebo comparator | Vehicle Receives: Drug: Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic
Measured: Day of Surgery
Secondary outcomes (1)
Safety
Measured: Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2008 (estimated)
- Study startDec 2007
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary CalculiStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Omeros Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Scott Houston, Study director, Omeros Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00599664
- Sponsor's protocol ID
- C07-001
- Status last verified
- Apr 2010
- First submitted
- 26 Dec 2007
- Last updated
- 30 Apr 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-Blind, Placebo-Controlled, Two-Center, Pharmacokinetic Study Evaluating the Systemic Absorption and Safety of OMS201 in Subjects Undergoing Ureteroscopic Treatment of Unilateral Ureteral- or Renal Collecting System-Located Stones
- ClinicalTrials.gov ID
- NCT00599664
- Acronym / sponsor ID
- C07-001
- Conditions
- Urinary Calculi, Urinary Stones, Urinary Tract Stones
- Keywords
- Urinary Calculi, Urinary Stones, Urinary Tract Stones, Calculi
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Omeros CorporationIndustry (pharma, biotech, devices)
- Study start
- Dec 2007
- Study completion
- Sep 2008 (actual)
- First posted
- 24 Jan 2008 (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.
Evaluate the safety and systemic absorption of OMS201 following exposure during ureteroscopy.
Detailed description
OMS201 is being developed to facilitate endoscopy of the ureters and to reduce postoperative discomfort, such as pain, frequency, urgency and/or difficult urination following endoscopic surgery to remove a urinary tract stone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: OMS201Drug |
| 2 | Placebo comparator | Drug: VehicleVehicle |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subject is undergoing unilateral ureteroscopic removal of renal collecting system or ureteral stones located in the ureter with a maximum stone diameter of 12 mm, for which general anesthesia will be used.
- Subject's physical examination is within normal limits or examination is clinically non-significant for purposes of the study as determined by the Investigator, and subject is in good general health.
- Subject's laboratory evaluations are within normal limits or evaluations are clinically non-significant as determined by the Investigator.
- Female subject of childbearing potential who is using an effective method of birth control within at least 14 days prior to surgery and has a negative pregnancy test.
- Subject is at minimal risk from anesthesia and is classified according to the American Society of Anesthesiologists Physical Status Classification as either PS-1 or PS-2.
Key exclusion criteria (8 listed)
- Subject taking a prohibited medication.
- Subject who has had a renal transplant, has a single kidney or has evidence of a compromised renal function as measured by abnormal serum creatinine, as judged by the Investigator, or who has evidence of urinary tract infection, or has prior history of open or laparoscopic surgery, or any history of an ureteral stricture.
- Subject who has congenital anomalies that would engender an increased procedural safety risk such as ureteropelvic junction obstruction resulting in severely dilated renal pelvis, duplicated urinary collecting system, horseshoe kidney or vascular anomalies such as renal arteriovenous fistulas or papillary necrosis.
- Subject has bilateral renal or ureteral stones requiring concurrent ureteroscopic removal.
- Subject with clinically significant hypotension at Screening.
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 |
|---|---|---|
| OMS201OMS201 irrigation solution during surgery | Drug | 1 |
| VehicleVehicle irrigation solution during surgery | Drug | 2 |
Primary outcome
Pharmacokinetic
Time frame: Day of Surgery
1 secondary outcome
Safety
Time frame: Day 7
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 30 Apr 2010.
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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.
Scott Houston study director
Omeros Corporation
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing OMS201 in people with Urinary Calculi and Urinary Stones, run by Omeros Corporation at 2 sites 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 8 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 30 Apr 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Pharmacokinetic (time frame: Day of Surgery). 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 30 Apr 2010.