Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase 2, 12 Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Proof Of Concept Study Evaluating The Efficacy And Safety Of PD 0299685 For The Treatment Of Symptoms Associated With Interstitial Cystitis/Painful Bladder Syndrome.
Brief Summary: The purpose of this study is to determine whether PD 0299685 is effective in the treatment of symptoms associated with interstitial cystitis/painful bladder syndrome, such as pain, urinary urgency and frequency. At the same time assess the drug's safety and tolerability.


Options:
A: Inclusion Criteria:

* Participant must report bladder pain/discomfort score of 3 or greater on a 0-10 Likert scale over the previous 4 weeks.
* Participant must report a symptom score of abnormal urinary frequency of 3 or greater on a 0-10 Likert scale over the previous 4 weeks.
* Symptoms of abnormal urinary frequency and bladder pain/discomfort must have been present for at least six weeks prior to screening visit.

Exclusion Criteria:

* Known allergy or intolerance to amitriptyline or any of its components.
* Currently receives treatment with amitriptyline or other tricyclic antidepressant, selective serotonin reuptake inhibitor (SSRI) or serotonin and norepinephrine reuptake inhibitor (SNRI), or monoamine oxidase (MAO) inhibitor antidepressants.
* Previous treatment with amitriptyline or other tricyclics, hydroxyzine or other antihistamines for bladder symptoms; pentosanpolysulfate; DMSO or any other intravesical therapy, biofeedback or pelvic floor physical therapy for PBS symptoms
B: Inclusion Criteria:

* Men and women over 18 years of age with moderate to severe interstitial cystitis defined by pain score.
* Women must not be pregnant or lactating, They may be post-menopausal, surgically sterilized or using an appropriate method of contraception.

Exclusion Criteria:

* History of interstitial cystitis less than 6 months
* History of current or recurrent urinary tract infections, or genitourinary cancer
* Any previous urinary diversion procedure with or without bladder removal, bladder augmentation
* Use of certain drugs given into the bladder up to 1 month prior to study entry
C: Inclusion Criteria:

1. Adults with age of 20 years old or above
2. Patients with symptoms of unpleasant sensation (pain, pressure, discomfort) perceived to be related to the urinary bladder, associated with lower urinary tract symptoms of more than six months duration, in the absence of infection or other identifiable causes
3. Patients has received cystoscopy and ruled out other bladder lesion
4. Free of active urinary tract infection
5. Free of bladder outlet obstruction on enrollment
6. Free of overt neurogenic bladder dysfunction and limitation of ambulation
7. Patient or his/her legally acceptable representative has signed the written informed consent form

Exclusion Criteria:

1. Patients had received intravesical hyaluronic acid treatment in recent 3 months, or intravesical Botox injection in recent 12 months Patients with severe cardiopulmonary disease and such as congestive heart failure, arrhythmia, poorly controlled hypertension, not able to receive regular follow-up
2. Patients with bladder outlet obstruction on enrollment
3. Patients with PVR \>100 ml
4. Patients with uncontrolled confirmed diagnosis of acute urinary tract infection
5. Patients have laboratory abnormalities at screening including: alanine aminotransferase (ALT)\> 3 x upper limit of normal range, and aspartate aminotransferase (AST) \> 3 x upper limit of normal range
6. Patients have abnormal serum creatinine level \> 2 x upper limit of normal range
7. Female patients who is pregnant, lactating, or with child-bearing potential without contraception
8. Patients with any other serious disease considered by the investigator not in the condition to enter the trial
9. Patients had received intravesical treatment for IC within recent 1 month
10. Patients had participated investigational drug trial within 1 month before entering this study
11. Patients with coagulopathy
D: Inclusion Criteria:

* Be females, ≥18 and ≤75 years of age, who have consistently had symptoms of bladder pain in addition to urinary urgency and/or urinary frequency for more than 12 months
* Have had the diagnosis of interstitial cystitis for \> 6 months (pain for at least 12 months) but ≤15 years
* Have average daily pain score of at least 5 out of 10 on the 11-point Numerical Rating Scale \[NRS\] pain scale in the 9 days prior to baseline
* Have undergone a cystoscopy and have documented visible signs of bladder bleeding, lesions or glomerulation within the last 36 months prior to baseline.
* Subjects if of child bearing potential, must agree to avoid pregnancy and use medically acceptable method of contraception from screening visit and throughout the study.
* Must be capable of voiding independently

Exclusion Criteria:

* Pelvic floor pain (\>5 out of 10 on the 11-point NRS pain scale following a pelvic pain assessment)
* Have a body mass index \[BMI\] of \<18 kg/m2 or \>39 kg/m2
* Have had a urinary tract infection including bacterial cystitis within the past 30 days.
* Have greater than 1+ hematuria on dipstick test at screening from an unknown cause
* History of previous procedure(s) (augmentation cystoplasty, cystectomy, or cystolysis) that has affected bladder function

Answer: B