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Lower Urinary Tract SymptomsPhase 2NCT02244281

Study of FLOMAX® Versus Placebo in Female Patients With Lower Urinary Tract Symptoms (LUTS) With a Significant Component of Voiding Symptoms

A Phase 2 study testing tamsulosin hydrochloride in people with Lower Urinary Tract Symptoms, run by Boehringer Ingelheim.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

1. To study the symptomatic improvement in LUTS afforded by FLOMAX® capsules, 0.4 mg daily compared to placebo, in female patients with lower urinary tract symptoms (LUTS) with a significant component of voiding symptoms 2. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Lower Urinary Tract Symptoms
What is being tested?
tamsulosin hydrochloride
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
74 participants
Where
No sites listed yet
Study dates
May 2001to Nov 2003
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
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult women, 18 years of age or older, currently diagnosed with LUTS with a significant component of voiding symptoms
  • The Patient must be diagnosed with one of the following: hesitancy, intermittency, difficulty in bladder emptying, or straining to void
  • Patients must have had an AUA Symptom Score of 13 or higher
  • Obstruction component of AUA Symptom Score (Items 1, 3, 5, and 6) had to be 5 points or higher
  • Patients that are currently taking alpha-blockers or anticholinergics must discontinue the drugs at least 2 weeks prior to Visit 1
  • Patients should show compliance of greater than or equal to 80% with placebo usage
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  • Patients should be surgically sterile, or 2 years postmenopausal, or practicing a medically acceptable method of birth control
  • Patients must have a negative urine Beta Human Chorionic Gonadotropin (beta-HCG)
  • Patients must be able to provide written informed consent prior to participation in the study in accordance with regulatory requirements
  • Patients must be judged by the investigator to be reliable and should comply with all tests and examinations stipulated in the protocol
  • All patients should be able to understand and read English

Who cannot join

  • Patients who presented with an active urinary tract infection or who had presented with two or more culture positive urinary tract infections within 6 months of the study
  • Patients with significant prolapse beyond the hymenal ring, per the investigator's judgment
  • Patients who had taken anticholinergic medications for the treatment of other urologic conditions and had not discontinued their use 2 weeks prior to study entry
  • Patients who had a history or active condition of renal or urethral calculi, urethral colic, mechanical outlet obstruction (i.e., bladder neck contracture or stricture, bladder tumor, or bladder calculi) 3 months prior to study entry
  • Patients with a history of bladder, vaginal or urethral surgery in the last 6 months
  • Patients who have a history of microscopic hematuria and not had a recent work-up including cystoscopy and upper urinary tract study (within 6 months of screening) or a diagnosis of a condition that may exclude the patient in the opinion of the investigator
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  • Abnormal urinalysis as defined by the following mid-stream, clean-catch specimen results:
  • A bacterial colony count of greater than 100,000/ml.
  • More than 10 leukocytes per high power field with more than two granular casts per high power field.
  • More than 10 red blood cells (non-menstrual tainted urine sample) per high power field.
  • Proteinuria >+1 (equivalent to >30 mg/dL)
  • Patients presenting with any of the following: history of a neurogenic bladder due to any neurologic condition that might involve the lower urinary tract, active urinary stone disease, previous pelvic radiotherapy, perirectal inflammatory disorder or inflammatory bowel disease
  • Patients that had a history of sexually transmitted diseases of the genitourinary system such as syphilis, herpes, gonorrhea, chlamydia, mycoplasma, trichomonas (within 3 months of the study) or any other diagnosis that in the opinion of the investigator may have excluded the patient
  • Patients that are pregnant or breast-feeding
  • The Patient has significant pelvic pain that demands treatment with narcotics
  • Large fluctuations in LUTS symptoms over the last 6 months (i.e., symptoms appearing and disappearing with unusual rapidity)
  • Any baseline (Visit 1) laboratory serum test with the following values: Hemoglobin: <11.0 g/dL, Leukocytes: <3,000 per mm3, Liver enzymes [serum glutamic oxaloacetic transaminase / Aspartate aminotransferase (SGOT/AST), serum glutamic pyruvic transaminase / Alanine transaminase (SGPT/ALT) or alkaline phosphatase]: more than two times the upper limit of normal at baseline (Visit 1). Serum creatinine more than two times the upper limit of normal at baseline (Visit 1)
  • Patients with a diagnosis of cancer, except basal cell carcinoma, within the past 5 years. (Note: Contact the Trial Clinical Monitor with any specific or special circumstances regarding the entry of a cancer patient.)
  • Participation in another drug study within 4 weeks of baseline (Visit 1)
  • Clinically relevant conditions which may interfere with the patient's ability to participate in the study including, but not limited to, the following: neurologic, gastrointestinal, cardiovascular, hepatic, renal, psychiatric, hematologic or respiratory disease and clinically relevant laboratory abnormalities not mentioned above (e.g., hematuria) based upon the clinical judgment of the investigator
  • Patients who have been receiving cimetidine, ranitidine and warfarin medications within 2 weeks of screening and who would potentially use such medication during the course of the trial
  • Patients with known hypersensitivity to FLOMAX® (tamsulosin hydrochloride) or other alpha-blockers
  • Patients with a history of myocardial infarction within 6 months of baseline (Visit 1)
  • Patients with uncontrolled hypertension (systolic >160 mmHg, diastolic >100 mmHg) and patients with severe hypotension (systolic <90 mmHg) after 5 minutes of sitting
  • Patients who have been using the following drugs, within 2 weeks prior to screening (Visit 1), and who are unable to discontinue these drugs over the course of the study
  • Alpha-adrenergic blocking agents
  • Alpha-adrenergic medication
  • Drugs with systemic anticholinergic activity including antihistamines. Antihistamines allowed are Allegra®, Claritin® and Zyrtec®
  • Antispasmodics or muscle relaxants
  • Parasympathomimetics, cholinomimetics, and/or similar drugs
  • Patients with poorly controlled diabetes mellitus based upon urine with 2+ (or greater) glucose on urinalysis, performed at screening (Visit 1).
  • Patients who suffer from neurological diseases affecting the bladder (i.e., multiple sclerosis, Parkinson's disease, stroke, and any bladder trauma that may have been an exclusion criterion in the opinion of the investigator)
  • Patients that have a neurological impairment or psychiatric disorder that prevents their comprehension of consent and their ability to comply with the protocol
  • Patients who had been diagnosed with interstitial cystitis according to the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) criteria
  • Patients that had a history of urethral syndrome whose treatment was other than dilation. Patients treated by dilation 3 months prior to study entry were allowed to participate in the study

About this study

Official title: An Eight-week, Double-blind, Randomized, Parallel Group Design, Multicenter Study of FLOMAX® Capsules, 0.4 mg Daily Versus Placebo, in Female Patients With Lower Urinary Tract Symptoms (LUTS) With a Significant Component of Voiding Symptoms

  1. To study the symptomatic improvement in LUTS afforded by FLOMAX® capsules, 0.4 mg daily compared to placebo, in female patients with lower urinary tract symptoms (LUTS) with a significant component of voiding symptoms
  2. To study the improvement afforded by FLOMAX® capsules versus placebo, in this patient population, in quality of life
  3. To assess the safety and tolerability of FLOMAX® capsules, 0.4 mg compared to placebo, in women suffering from LUTS with a significant component of voiding symptoms
Being tested
tamsulosin hydrochloride, Placebo
Medical subject headings
Lower Urinary Tract Symptoms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • tamsulosin hydrochlorideDrug

    Also called FLOMAX®

  • PlaceboDrug

Study groups in NCT02244281
Study groupRoleWhat they receive
FLOMAX®ExperimentalNot described
Receives: Drug: tamsulosin hydrochloride
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Assessment of efficacy on a American Urological Association (AUA) Symptom Score Index

    Measured: Up to day 56 after first study drug administration

Secondary outcomes (6)

  1. Assessment of Quality of Life on a incontinence impact questionary and urogenital distress inventory

    Measured: Up to day 56 after first study drug administration

  2. Assessment of urinary frequency and nocturia on a seventy-two hour voiding diary

    Measured: Up to day 28 after first study drug administration

  3. Assessment of urinary obstruction

    by uroflowmetry

    Measured: Up to day 56 after first study drug administration

  4. Assessment of Post-Void Residual volume

    by pelvic ultrasound

    Measured: Up to day 56 after first study drug administration

  5. Assessment of lower urinary tract symptoms of obstruction

    (voiding, Items 1, 3, 5 and 6), irritation (storage, Items 2, 4 and 7) and nocturia (Item 7) by AUA Symptom Score Index sub scores

    Measured: Up to day 56 after first study drug administration

  6. Number of patients with adverse events

    Measured: Up to day 56 after first study drug administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2014 (estimated)
  2. Study startMay 2001
  3. Primary completionNov 2003

Resources

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
Double blind
Enrolment
74 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02244281
Sponsor's protocol ID
527.25
Status last verified
Sep 2014
First submitted
18 Sep 2014
Last updated
19 Sep 2014
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing tamsulosin hydrochloride in people with Lower Urinary Tract Symptoms, run by Boehringer Ingelheim.

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 11 inclusion and 35 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 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.

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?

Assessment of efficacy on a American Urological Association (AUA) Symptom Score Index (time frame: Up to day 56 after first study drug administration). 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 NCT02244281.

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 Sep 2014.

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