Urinary CalculiPhase 1/2NCT00857090
Pharmacokinetic, Safety and Efficacy Study of OMS201 in Subjects Undergoing Retrograde Ureteroscopic Removal of Upper Urinary Tract Stones
A Phase 1/2 study testing OMS201 in people with Urinary Calculi and Urinary Stones, run by Omeros Corporation at 4 sites in United States.
Trial summary
The objectives of the study are to assess the systemic exposure, safety and efficacy of three concentrations of OMS201 in subjects undergoing retrograde ureteroscopic removal of upper urinary tract stones. 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
- 18 participants
- Where
- 4 sitesUnited States
- Study dates
- Mar 2009to Dec 2010
- Phase
- Phase 1/2
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 - 65 years of age.
- Subject is undergoing retrograde ureteroscopic removal of renal-collecting system or ureteral stones for which general anesthesia will be used.
Who cannot join
- No allergies to any of the individual ingredients in OMS201.
- Subject taking a prohibited medication.
- Pregnant woman, nursing mother, or woman of child-bearing age unwilling to take contraception for the duration of the study.
- Subject who has had a renal transplant, has a single kidney, has compromised renal function, or has evidence of papillary necrosis.
- Subject who has evidence of a clinically significant urinary tract infection.
- Subject who has a prior history of open or laparoscopic urinary tract surgery, or a history of a ureteral stricture.
Show all 13Show fewer
- Subject who has congenital anomalies that would engender an increased procedural safety risk.
- Subject with a history of clinically significant chronic or episodic hypotension.
- Subject's physical examination is significantly abnormal for purposes of the study as determined by the Investigator.
- Subject's screening laboratory evaluations are not within normal limits AND abnormal results are determined by the Investigator to be clinically significant.
- Subject is at risk from anesthesia.
- Subject is on chronic diuretic use.
- Subject has a present condition or history of any clinically significant medical disorder and is determined by the Investigator to be an unsuitable candidate for receipt of an investigational drug.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Urology Center of Colorado
Denver, Colorado, 80211
Urology Associates
Nasville, Tennessee, 37209
University of California Irvine Medical Center
Orange, California, 92868
Urology San Antonio Research
San Antonio, Texas, 78229
About this study
Official title: Double-Blind, Placebo-Controlled, Concentration-Escalating, Pharmacokinetic Study Evaluating the Systemic Absorption, Safety, and Efficacy of OMS201 in Subjects Undergoing Ureteroscopic Treatment of Ureteral- or Renal Collecting System-Located Stones
The objectives of the study are to assess the systemic exposure, safety and efficacy of three concentrations of OMS201 in subjects undergoing retrograde ureteroscopic removal of upper urinary tract stones.
Read the detailed description
The main objective is to estimate the systemic exposure of OMS201 in retrograde ureteroscopic treatment of upper urinary tract stones. Safety will be assessed by vital signs, laboratory values and adverse events. Exploratory efficacy measures will assess the effect of OMS201 on postoperative pain, duration of surgery and ease of placement of a ureteral access sheath.
- Being tested
- OMS201, Vehicle
- Keywords
- Urinary Calculi, Urinary Stones, Urinary Tract Stones, Renal Calculi, Kidney Stones, Calculi, Urolithotomy, Ureteroscopy
- Medical subject headings
- Urinary Calculi, Kidney Calculi, Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OMS201Drug
Stage 1: OMS201 irrigation solution at 3X the base concentration during surgery
Stage 2: OMS201 irrigation solution up to 10X the base concentration during surgery
VehicleDrug
Stages 1-2: 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.
Peak systemic exposure.
Measured: Day of surgery
Secondary outcomes (4)
Safety
Measured: Day 7
Degree of pain
Measured: 7 days
Duration of the operation
Measured: Day of surgery
Ease of placement of the ureteral access sheath
Measured: Day of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2009 (estimated)
- Study startMar 2009
- Primary completionDec 2010
- Study completionDec 2010
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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Omeros Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00857090
- Sponsor's protocol ID
- C08-001
- Status last verified
- Oct 2012
- First submitted
- 4 Mar 2009
- Last updated
- 12 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-Blind, Placebo-Controlled, Concentration-Escalating, Pharmacokinetic Study Evaluating the Systemic Absorption, Safety, and Efficacy of OMS201 in Subjects Undergoing Ureteroscopic Treatment of Ureteral- or Renal Collecting System-Located Stones
- ClinicalTrials.gov ID
- NCT00857090
- Acronym / sponsor ID
- C08-001
- Keywords
- Urinary Calculi, Urinary Stones, Urinary Tract Stones, Renal Calculi, Kidney Stones, Calculi, Urolithotomy, Ureteroscopy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Omeros CorporationIndustry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 6 Mar 2009 (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 objectives of the study are to assess the systemic exposure, safety and efficacy of three concentrations of OMS201 in subjects undergoing retrograde ureteroscopic removal of upper urinary tract stones.
Detailed description
The main objective is to estimate the systemic exposure of OMS201 in retrograde ureteroscopic treatment of upper urinary tract stones. Safety will be assessed by vital signs, laboratory values and adverse events. Exploratory efficacy measures will assess the effect of OMS201 on postoperative pain, duration of surgery and ease of placement of a ureteral access sheath.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- 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 (2 listed)
- 18 - 65 years of age.
- Subject is undergoing retrograde ureteroscopic removal of renal-collecting system or ureteral stones for which general anesthesia will be used.
Key exclusion criteria (13 listed)
- No allergies to any of the individual ingredients in OMS201.
- Subject taking a prohibited medication.
- Pregnant woman, nursing mother, or woman of child-bearing age unwilling to take contraception for the duration of the study.
- Subject who has had a renal transplant, has a single kidney, has compromised renal function, or has evidence of papillary necrosis.
- Subject who has evidence of a clinically significant urinary tract infection.
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 |
|---|---|---|
| OMS201Stage 1: OMS201 irrigation solution at 3X the base concentration during surgery Stage 2: OMS201 irrigation solution up to 10X the base concentration during surgery | Drug | 1 |
| VehicleStages 1-2: Vehicle irrigation solution during surgery | Drug | 2 |
Primary outcome
Peak systemic exposure.
Time frame: Day of surgery
4 secondary outcomes
Safety
Time frame: Day 7
Degree of pain
Time frame: 7 days
Duration of the operation
Time frame: Day of surgery
Ease of placement of the ureteral access sheath
Time frame: Day of surgery
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 12 Oct 2012.
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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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing OMS201 in people with Urinary Calculi and Urinary Stones, run by Omeros Corporation at 4 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 2 inclusion and 13 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 12 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 combined 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.
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?
Peak systemic exposure. (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 12 Oct 2012.