Pelvic PainPhase 2NCT00256542
Study of U101 for Bladder Pain and/or Urgency
A Phase 2 study testing Alkalinized Lidocaine-Heparin in people with Pelvic Pain and Interstitial Cystitis, run by Urigen at 9 sites in United States.
Trial summary
The purpose of this study is to determine whether intravesical U101 (alkalinized lidocaine-heparin) treatment reduces the symptoms of pelvic pain and/or urgency of bladder origin. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pelvic Pain, Interstitial Cystitis, Bladder Diseases
- What is being tested?
- Alkalinized Lidocaine-Heparin
- How many people
- 90 participants
- Where
- 9 sitesUnited States
- Study dates
- Jan 2006to Sep 2006
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female subjects at least 18 years of age.
- Subjects must have given written informed consent to participate in this trial.
- All female subjects, except those who are post-menopausal and/or surgically sterilized, must consent to use two medically acceptable methods of contraception throughout the entire study period. Medically acceptable methods of contraception that may be used by the subject and/or her partner include: abstinence, birth control pills, diaphragm with spermicide, intrauterine device (IUD), condom and foam, vaginal spermicidal suppository, progestin implant, and Depo-Provera injections.
- Subjects must have had symptoms of pelvic pain and/or urgency.
- Medical history and physical examination results must be clinically acceptable to the Investigator. Medical Monitor may evaluate subjects who don't meet eligibility criteria.
- Female subjects currently using hormone therapy (HT) must have been using HT for at least 3 months.
Who cannot join
- Subjects less than 18 years of age.
- Subjects with known hypersensitivity to heparin or lidocaine.
- Female subjects who have a positive pregnancy test at the time of screening, who are pregnant or lactating, or who are planning to become pregnant during the study period.
- Subjects who are chronic users of narcotics or who are using any narcotics at the time of study entry.
- Subjects who have hepatic disease or clinically significant abnormal liver function tests (more than twice the upper limit of the normal range).
- Subjects who do not expect to be available for the entire duration of the study.
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- Subjects with any coexisting significant medical condition that is likely to interfere with study procedures (cardiovascular, hematological, central nervous system, pulmonary, renal, etc.)
- Subjects who have been treated with dimethyl sulfoxide (DMSO) or other bladder instillation therapies within three months prior to study entry.
- Subjects who have had cystoscopic dilatation of their bladder or urethra within three months of study entry.
- Subjects who have taken or used any investigational drug or device within 30 days before the start of the study, or who are currently enrolled in another investigational study.
- Subjects contemplating having or scheduled for any invasive surgical procedures during the study period.
- Subjects who are unwilling or unable to abide by the requirements of the study.
- History of gastrointestinal (GI) bleeding
- Active bleeding from any source
- Screening activated partial thromboplastin time (aPTT) above normal limits
- Systolic blood pressure (BP) > 180 mmHg or < 90 mmHg at Screening.
- Subjects with an actively bleeding lesion/area in the bladder as detected by urinalysis
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Georgia Urology
Cartersville, Georgia, 30120
St. Mary's Good Samaritan
Centralia, Illinois, 62801
The Urology Center
Greensboro, North Carolina, 27403
Mid-Michigan Health Centers
Jackson, Michigan, 49201
Central Park Urology
New York, New York, 10019
The Urogynecology Center
Overland Park, Kansas, 66215
Whitmore Urology Office
Philadelphia, Pennsylvania, 19146
UCSD Medical Center
San Diego, California, 92103
Urologic Specialists of Oklahoma, Inc.
Tulsa, Oklahoma, 74146
About this study
Official title: A Phase II Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Intravesical Alkalinized Lidocaine-Heparin for the Symptoms of Pelvic Pain and/or Urgency of Bladder Origin
The purpose of this study is to determine whether intravesical U101 (alkalinized lidocaine-heparin) treatment reduces the symptoms of pelvic pain and/or urgency of bladder origin.
- Conditions
- Pelvic Pain, Interstitial Cystitis, Bladder Diseases
- Being tested
- Alkalinized Lidocaine-Heparin
- Keywords
- interstitial cystitis, pelvic pain, urgency, frequency, Pelvic Pain and/or Urgency of Bladder Origin
- Medical subject headings
- Pelvic Pain, Cystitis, Interstitial, Urinary Bladder Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alkalinized Lidocaine-HeparinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall improvement in combined symptoms of pain and urgency at 3 weeks
Secondary outcomes (7)
Safety
Reduction in pain on ten point scale at 3 weeks
Reduction in urgency on ten point scale at 3 weeks
Change in number of voids/24 hours
Change in average void volume
Reduction in PUF score (pelvic pain, urgency/frequency) at 3 weeks
Reduction in O'Leary-Sant score at 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2005 (estimated)
- Study startJan 2006
- Study completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pelvic PainStudies 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
- Single group
- Masking
- Double blind
- Enrolment
- 90 participants
Sponsor and investigators
- Lead sponsor
- Urigen
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- C. Lowell Parsons, MD, Principal investigator, UCSD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00256542
- Sponsor's protocol ID
- URG-101
- Status last verified
- Aug 2006
- First submitted
- 17 Nov 2005
- Last updated
- 29 Sep 2006
- Results posted
- No
Publications
Parsons CL. Successful downregulation of bladder sensory nerves with combination of heparin and alkalinized lidocaine in patients with interstitial cystitis. Urology. 2005 Jan;65(1):45-8. doi: 10.1016/j.urology.2004.08.056.
PubMed 15667861
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Intravesical Alkalinized Lidocaine-Heparin for the Symptoms of Pelvic Pain and/or Urgency of Bladder Origin
- ClinicalTrials.gov ID
- NCT00256542
- Acronym / sponsor ID
- URG-101
- Conditions
- Pelvic Pain, Interstitial Cystitis, Bladder Diseases
- Keywords
- interstitial cystitis, pelvic pain, urgency, frequency, Pelvic Pain and/or Urgency of Bladder Origin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants
- Lead sponsor
- UrigenIndustry (pharma, biotech, devices)
- Study start
- Jan 2006
- Study completion
- Sep 2006
- First posted
- 21 Nov 2005 (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 determine whether intravesical U101 (alkalinized lidocaine-heparin) treatment reduces the symptoms of pelvic pain and/or urgency of bladder origin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male and female subjects at least 18 years of age.
- Subjects must have given written informed consent to participate in this trial.
- All female subjects, except those who are post-menopausal and/or surgically sterilized, must consent to use two medically acceptable methods of contraception throughout the entire study period. Medically acceptable methods of contraception that may be used by the subject and/or her partner include: abstinence, birth control pills, diaphragm with spermicide, intrauterine device (IUD), condom and foam, vaginal spermicidal suppository, progestin implant, and Depo-Provera injections.
- Subjects must have had symptoms of pelvic pain and/or urgency.
- Medical history and physical examination results must be clinically acceptable to the Investigator. Medical Monitor may evaluate subjects who don't meet eligibility criteria.
Key exclusion criteria (17 listed)
- Subjects less than 18 years of age.
- Subjects with known hypersensitivity to heparin or lidocaine.
- Female subjects who have a positive pregnancy test at the time of screening, who are pregnant or lactating, or who are planning to become pregnant during the study period.
- Subjects who are chronic users of narcotics or who are using any narcotics at the time of study entry.
- Subjects who have hepatic disease or clinically significant abnormal liver function tests (more than twice the upper limit of the normal range).
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 |
|---|---|---|
| Alkalinized Lidocaine-Heparin | Drug | – |
Primary outcome
Overall improvement in combined symptoms of pain and urgency at 3 weeks
7 secondary outcomes
Safety
Reduction in pain on ten point scale at 3 weeks
Reduction in urgency on ten point scale at 3 weeks
Change in number of voids/24 hours
Change in average void volume
Reduction in PUF score (pelvic pain, urgency/frequency) at 3 weeks
Reduction in O'Leary-Sant score at 3 weeks
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 29 Sep 2006.
- Background: PubMed 15667861Parsons CL. Successful downregulation of bladder sensory nerves with combination of heparin and alkalinized lidocaine in patients with interstitial cystitis. Urology. 2005 Jan;65(1):45-8. doi: 10.1016/j.urology.2004.08.056.
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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.
C. Lowell Parsons, MD principal investigator
UCSD
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Alkalinized Lidocaine-Heparin in people with Pelvic Pain and Interstitial Cystitis, run by Urigen at 9 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 17 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 29 Sep 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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. 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?
Overall improvement in combined symptoms of pain and urgency at 3 weeks. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00256542, which also lists 1 linked publication.
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 29 Sep 2006.