Interstitial CystitisPhase 2NCT00295854
Phase II Study Efficacy and Safety of Two Dosing Regimens of MN-001 in Patients With Interstitial Cystitis
A Phase 2 study testing MN-001 BID and MN-001 in people with Interstitial Cystitis, run by MediciNova at 28 sites in United States.
Trial summary
To evaluate the safety and efficacy of 8 weeks of treatment with MN-001 at 500 mg bid, 500 mg once daily vs. placebo in patients with Interstitial Cystitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Interstitial Cystitis
- What is being tested?
- MN-001 BID and MN-001
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 296 participants
- Where
- 28 sitesUnited States
- Study dates
- May 2005to Oct 2006
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 or female ≥ 18 years of age with a diagnosis of moderate to severe IC;
- Bladder pain ≥ 6 months prior to baseline;
- Urinary frequency of ≥ 8 ≤ 30 micturitions within 24 hours while awake;
- Nocturia ≥ 2x/night;
- Males and females of child-bearing potential (not surgically sterile or post-menopausal) must be abstinent or agree to use an study-accepted contraceptive regimens throughout the study:
- Female patients of child bearing age must have a negative urine pregnancy test at screening;
- Must provide a signed informed consent.
Who cannot join
- Male or females < 18 years of age;
- Initiation of new IC medication ≤ 30 days prior to baseline;
- Treatment with Elmiron ≤ 120 days prior to baseline;
- Treatment with bladder hydro-distention ≤ 6 months prior to baseline;
- Treatment with intravesical therapy ≤ 60 days prior to baseline;
- History of previous procedure(s) (e.g., augmentation cytoplasty, cystectomy or cystolysis) that has affected bladder function;
Show all 15Show fewer
- Active genital herpes or vaginitis ≤ 90 days prior to baseline;
- Urinary tract or prostatic infection ≤ 90 days prior to baseline;
- History of urethral diverticulum;
- History of bladder or ureteral calculi;
- History of cyclophosphamide or chemical cystitis, urinary tuberculosis or radiation cystitis;
- History of bladder tumors;
- History of uterine, cervical, vaginal, prostatic or urethral cancer ≤ 5 years prior to baseline;
- Patient is currently pregnant, lactating or likely to become pregnant during the study;
- Participated in another clinical study with an investigational drug or device ≤ 30 days prior to baseline.
Trial locations and contacts
28 sites in 1 country.
28 sites in 1 country
United States28 sites
Upstate Urology
Albany, New York, 12206
Shepherd Center, Inc.
Atlanta, Georgia, 30309
Segal Institute for Clinical Research
Aventura, Florida, 33180
MediciNova Investigational Site
Birmingham, Alabama, 35294
Boulder Medical Center, P.C.
Boulder, Colorado, 80304
Visions Clinical Research
Boynton Beach, Florida, 33437
Center For Advanced Pelvic Surgery
Centralia, Illinois, 62801
Tristate Urologic Services PSC., Inc.
Cincinnati, Ohio, 45212
Medical Arts Clinic
Corsicana, Texas, 75110
Evanston Continence Center
Evanston, Illinois, 60201
Gant Foundation
Fort Worth, Texas, 76104
Citrus Valley Urological Medical Group
Glendora, California, 91741
The Urology Group
Greer, South Carolina, 29650
Sheldon J. Freedman, MD, LTD
Las Vegas, Nevada, 89109
Midwest Regional Center For Chronic Pelvic Pain and Bladder Control
Lima, Ohio, 45805
Atlantic Urological Medical Group
Long Beach, California, 90806
Associated Urologic Specialists, P.A.
Marlton, New Jersey, 08053
Integrity Medical Research, LLC
Mountlake Terrace, Washington, 98043
Brian Heaton, MD
Ogden, Utah, 84403
West Florida Urology
Palm Harbor, Florida, 34684
Adult and Pediatric Urology
Plantation, Florida, 33317
William Beaumont Hospital
Royal Oak, Michigan, 48073
Mendez Transplant and Urological Medical Group
San Diego, California, 92103
Regional Urology, LLC
Shreveport, Louisiana, 71106
Williamette Women's Healthcare P.C.
Tualatin, Oregon, 97062
Georgis Patsias, MD., PA
Wellington, Florida, 33414
Western Urologic Research Center
Wheat Ridge, Colorado, 80033
Lyndhurst Gynecology Associates
Winston-Salem, North Carolina, 27103
About this study
Official title: A Phase II, Randomized, Double-blind, Placebo-controlled, Multi-center Study to Evaluate the Efficacy and Safety of Two Dosing Regimens of MN-001 in Patients With Interstitial Cystitis
To evaluate the safety and efficacy of 8 weeks of treatment with MN-001 at 500 mg bid, 500 mg once daily vs. placebo in patients with Interstitial Cystitis.
Read the detailed description
This is a randomized, double-blind, placebo-controlled, multi-center study to evaluate the efficacy and safety of two dosing regimens of MN-001 in patients with Interstitial Cystitis (IC). Patients will be screened for study eligibility within seven to nine days of randomization. Eligible patients will be randomized in a 1:1:1 ratio to receive either 500 mg MN-001 bid, 500 mg MN-001 once daily or placebo. Patients will be dispensed study drug beginning at Baseline (Visit 2) and will return to the study center for Visit 3 (28 days ± 2 days after Baseline), and Visit 4 (56 days ± 2 days after Baseline), at end of study for safety and efficacy assessments. The patient will be contacted by telephone at Week 6 (42 days ± 2 days after Baseline) for an interim follow up. Study drug will be dispensed at Visits 2 and 3. Safety assessments will include adverse events, physical examinations, clinical laboratory testing, and changes in vital signs. Efficacy assessments include percentage of patients at least "moderately improved" for each treatment group using the patient reported Global Response Assessment (GRA) (see Appendix 1). Secondary assessments include a decrease in bladder pain/urgency based on change in the patient rating from baseline to endpoint using the GRA (see Appendix 1), modified Pelvic Pain and Urgency/Frequency (PUF) Patient Symptom Scale (see Appendix 2) and the O'Leary Sant IC Symptom and Problem Index.
- Conditions
- Interstitial Cystitis
- Being tested
- MN-001 BID, MN-001, Placebo
- Keywords
- Interstitial Cystitis, urgency, frequency, MN-001, Global Response Assessment, bladder pain/urgency, O'Leary Sant IC Symptom and Problem Index
- Medical subject headings
- Cystitis, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MN-001 BIDDrug
Eligible patients received 500 mg MN-001 bid
MN-001Drug
Eligible patients received 500 mg MN-001 once daily (qd)
PlaceboDrug
Eligible patients received placebo
| Study group | Role | What they receive |
|---|---|---|
| MN-001 | Experimental | Not described Receives: Drug: MN-001 BID; Drug: MN-001 |
| MN-001 once daily | Placebo comparator | placebo tablets Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number Subjects at Least "Moderately Improved" for Each Treatment Group in Patient Reported Global Response Assessment (GRA)
The primary endpoint was the GRA overall change "in their condition" at Week 8. Each patient completed the questionnaire that rated the improvement in their IC symptoms based on responses to the GRA questions. Each question asked the patient to describe the OVERALL CHANGE in pain, urgency, frequency or overall change in their problem compared to the status before taking the study medication. Each parameter was rated on a 7 point scale: markedly worse, moderately worse, mildly worse, same, mildly improved, moderately improved and markedly improved.
Measured: 8 weeks
Secondary outcomes (1)
Number of Responders for GRA Assessment in Their Condition at Week 4.
Responders were defined as patients who were 'moderately improved' or 'markedly improved' and non-responders were defined as patients who were 'markedly worse', 'moderately worse', 'mildly worse', no change, or 'mildly improved' on the GRA assessments.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2006 (estimated)
- Study startMay 2005
- Primary completionOct 2006
- Study completionOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Interstitial CystitisStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 296 participants (actual)
Sponsor and investigators
- Lead sponsor
- MediciNova
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Richard E Gammans, MD, Study director, MediciNova, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00295854
- Sponsor's protocol ID
- MN-001-CL-002
- Status last verified
- Dec 2011
- First submitted
- 22 Feb 2006
- Last updated
- 19 Jan 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Randomized, Double-blind, Placebo-controlled, Multi-center Study to Evaluate the Efficacy and Safety of Two Dosing Regimens of MN-001 in Patients With Interstitial Cystitis
- ClinicalTrials.gov ID
- NCT00295854
- Acronym / sponsor ID
- MN-001-CL-002
- Conditions
- Interstitial Cystitis
- Keywords
- Interstitial Cystitis, urgency, frequency, MN-001, Global Response Assessment, bladder pain/urgency, O'Leary Sant IC Symptom and Problem Index
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 296 participants (actual)
- Lead sponsor
- MediciNovaIndustry (pharma, biotech, devices)
- Study start
- May 2005
- Primary completion
- Oct 2006 (actual)
- Study completion
- Oct 2006 (actual)
- First posted
- 24 Feb 2006 (estimated)
- Results
- Posted 19 Jan 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the safety and efficacy of 8 weeks of treatment with MN-001 at 500 mg bid, 500 mg once daily vs. placebo in patients with Interstitial Cystitis.
Detailed description
This is a randomized, double-blind, placebo-controlled, multi-center study to evaluate the efficacy and safety of two dosing regimens of MN-001 in patients with Interstitial Cystitis (IC). Patients will be screened for study eligibility within seven to nine days of randomization. Eligible patients will be randomized in a 1:1:1 ratio to receive either 500 mg MN-001 bid, 500 mg MN-001 once daily or placebo. Patients will be dispensed study drug beginning at Baseline (Visit 2) and will return to the study center for Visit 3 (28 days ± 2 days after Baseline), and Visit 4 (56 days ± 2 days after Baseline), at end of study for safety and efficacy assessments. The patient will be contacted by telephone at Week 6 (42 days ± 2 days after Baseline) for an interim follow up. Study drug will be dispensed at Visits 2 and 3. Safety assessments will include adverse events, physical examinations, clinical laboratory testing, and changes in vital signs. Efficacy assessments include percentage of patients at least "moderately improved" for each treatment group using the patient reported Global Response Assessment (GRA) (see Appendix 1). Secondary assessments include a decrease in bladder pain/urgency based on change in the patient rating from baseline to endpoint using the GRA (see Appendix 1), modified Pelvic Pain and Urgency/Frequency (PUF) Patient Symptom Scale (see Appendix 2) and the O'Leary Sant IC Symptom and Problem Index.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MN-001 | Experimental | Drug: MN-001 BID, Drug: MN-001 |
| MN-001 once daily | Placebo comparator | Drug: Placeboplacebo tablets |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female ≥ 18 years of age with a diagnosis of moderate to severe IC;
- Bladder pain ≥ 6 months prior to baseline;
- Urinary frequency of ≥ 8 ≤ 30 micturitions within 24 hours while awake;
- Nocturia ≥ 2x/night;
- Males and females of child-bearing potential (not surgically sterile or post-menopausal) must be abstinent or agree to use an study-accepted contraceptive regimens throughout the study:
Key exclusion criteria (15 listed)
- Male or females < 18 years of age;
- Initiation of new IC medication ≤ 30 days prior to baseline;
- Treatment with Elmiron ≤ 120 days prior to baseline;
- Treatment with bladder hydro-distention ≤ 6 months prior to baseline;
- Treatment with intravesical therapy ≤ 60 days prior to baseline;
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 |
|---|---|---|
| MN-001 BIDEligible patients received 500 mg MN-001 bid | Drug | MN-001 |
| MN-001Eligible patients received 500 mg MN-001 once daily (qd) | Drug | MN-001 |
| PlaceboEligible patients received placebo | Drug | MN-001 once daily |
Primary outcome
Number Subjects at Least "Moderately Improved" for Each Treatment Group in Patient Reported Global Response Assessment (GRA)
Time frame: 8 weeks
The primary endpoint was the GRA overall change "in their condition" at Week 8. Each patient completed the questionnaire that rated the improvement in their IC symptoms based on responses to the GRA questions. Each question asked the patient to describe the OVERALL CHANGE in pain, urgency, frequency or overall change in their problem compared to the status before taking the study medication. Each parameter was rated on a 7 point scale: markedly worse, moderately worse, mildly worse, same, mildly improved, moderately improved and markedly improved.
1 secondary outcome
Number of Responders for GRA Assessment in Their Condition at Week 4.
Time frame: 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Richard E Gammans, MD study director
MediciNova, Inc.
28 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 MN-001 BID and MN-001 in people with Interstitial Cystitis, run by MediciNova at 28 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 7 inclusion and 15 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 19 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 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 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?
Yes. Results are posted in the registry (first posted 19 Jan 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number Subjects at Least "Moderately Improved" for Each Treatment Group in Patient Reported Global Response Assessment (GRA) (time frame: 8 weeks). 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 19 Jan 2012.