CTRI/2022/06/043152 [Registered on: 10/06/2022] Trial Registered Prospectively
Last Modified On:
12/04/2023
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Other
Public Title of Study
A study of Fixed Dose Combination of Tamsulosin and Tadalafil Capsules to check safety and efficacy in Patients with Benign Prostatic Hyperplasia and Erectile Dysfunction.
Scientific Title of Study
A Prospective, Multi-center, Single-arm, Phase IV Study to Assess the Safety and Efficacy of Fixed Dose Combination of Tamsulosin Hydrochloride Prolonged Release and Tadalafil Capsules in Patients with Benign Prostatic Hyperplasia and Erectile Dysfunction.
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
Protocol No.: ICR/21/013 Version: 2.0 Date: 27 Jan 2022
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Dharmesh Domadia
Designation
Vice President - Global Clinical Operations
Affiliation
Cliantha Research Limited
Address
TP 86, FP 28/1,
Off S.P. Ring Road, Sarkhej,
Ahmedabad-382210,
Gujarat, India
Ahmadabad GUJARAT 382210 India
Phone
91-2717-698500
Fax
Email
ddomadia@cliantha.com
Details of Contact Person Scientific Query
Name
Dr Nil Desai
Designation
Senior Manager Medical Services
Affiliation
Cliantha Research Limited
Address
TP 86, FP 28/1,
Off S.P. Ring Road, Sarkhej,
Ahmedabad-382210,
Gujarat, India
Ahmadabad GUJARAT 382210 India
Phone
919879732959
Fax
Email
nhdesai@cliantha.com
Details of Contact Person Public Query
Name
Mr Devesh Verma
Designation
Associate Director-I
Affiliation
Cliantha Research Limited
Address
TP 86, FP 28/1,
Off S.P. Ring Road, Sarkhej,
Ahmedabad-382210,
Gujarat, India
Ahmadabad GUJARAT 382210 India
Phone
919712908404
Fax
Email
dverma@cliantha.com
Source of Monetary or Material Support
Sun Pharma Laboratory Limited (SPLL), Mumbai
Primary Sponsor
Name
Sun Pharma Laboratory Limited SPLL
Address
Sun House, Plot No. 201, B/1, Western Highway, Goregoan (E) , Mumbai 400063, Maharashtra, India.
Advanced urology centre, Post graduate Institute of medical education and research
sector 12 Chandigarh CHANDIGARH
9592918983
aditya.p.sharma@gmail.com
DrVikky Ajwani
Anand Multispecialty Hospital
B-tower Sundarvan complex, Gorwa Refinery Road, Near Gorwa beside IOCL Petrol Pump Vadodara GUJARAT
9601987566
Vikkyajwani@gmail.com
Dr Shah Ishan Hemant kumar
Dr. M K Shah Medical college & Research Centre, Smt. SMS Multispecialty Hospital,
Room No 2, General Surgery OPD, Dr. M K Shah Medical college & Research Centre, Smt. SMS Multispecialty Hospital, Ahmedabad-382424,Gujarat Ahmadabad GUJARAT
Tamsulosin Hydrochloride Prolonged Release and Tadalafil Capsules
Fixed Dose Combination of Tamsulosin Hydrochloride Prolonged Release and Tadalafil Capsules
One capsule once daily should be taken orally approximately half hour following same meal at night time
Dose: 0.4 + 5 mg
Route of administration: Orally Frequency: once daily should be taken orally approximately half hour following same meal at night time
Duration of therapy: 12 weeks
Inclusion Criteria
Age From
45.00 Year(s)
Age To
75.00 Year(s)
Gender
Both
Details
1) Sexually active male patient, aged between 45 to 75 years (both inclusive), diagnosed with BPH and Erectile dysfunction
2) Patient who is taking both Tamsulosin 0.4 mg and Tadalafil 5 mg concomitantly for BPH and ED at Screening [Note: Patients will undergo a wash out period of 28 days)
3) Patient having total International Prostate Symptom Score (IPSS) score ≥ 8 (moderate to severe BPH) at the time of enrolment
4) Patient having Qmax between 5 ml/sec and 15 ml/sec (both included) with minimum voided volume of >125 ml at the time of enrolment
5) Patient with PVR volume < 300 mL as assessed by ultrasound at enrolment
6) Patient with International Index of Erectile Function - Erectile Function Domain (IIEF-EF) of ≤ 25 at the time of enrolment
7) Patient is willing to give informed consent, able to swallow study medications and follow study protocol.
ExclusionCriteria
Details
1) Prostate specific antigen (PSA) beyond 4 ng/mL at screening, and enrolment
2) Patient with history of neurologic bladder, urethral strictures, urinary tract infections, prostatitis, urologic cancer, and prostatic surgery
3) Patient with clinically significant bladder outflow obstruction other than BPH (calculi, tumor or stricture) as judged by Investigator
4) Clinical evidence of any other bladder or urinary tract conditions, which may affect lower urinary tract symptom at screening
5) Patient undergoing haemodialysis
6) Patient who are planning for cataract or glaucoma surgery
7) Patients with history of cardiovascular disease (including but not limited to):
- History of myocardial infarction within the last 90 days
- History of angina
- History of Congestive cardiac failure (New York Heart Association Class 2 or higher) in the last 6 months
- Patients with uncontrolled arrhythmias, hypotension (BP<90/60 mm Hg) or uncontrolled hypertension (≥170/100 mmHg)
- History of orthostatic hypotension, or recurrent dizziness, vertigo, loss of consciousness or syncope
- History of stroke within the last 6 months
Known left ventricular outflow tract obstruction (e.g., aortic stenosis and idiopathic hypertrophic subaortic valve stenosis)
- Patients with any other cardiac disease for which sexual activity is not recommended
8) Patient with any other clinically significant disorder that (for e.g. Patient who is likely to require catheterization within next 3 months, unable to take oral medications), in the opinion of the Investigator, would result in the patient’s inability to understand and comply with the requirements of the study
9) Patients with anatomical deformation of the penis (such as angulation, cavernosal fibrosis, or Peyronies disease)
10) Patients history of priapism with prior use of α1-blocker(s)/PDE-5 inhibitors (or combination of both), or have known condition(s) which may predispose them to priapism (e.g. Sickle cell anemia) as per Investigator’s discretion
11) Patient with history of hereditary degenerative retinal disorders (e.g., retinitis pigmentosa) or ischemic optic neuropathy including non-arteritic anterior ischemic optic neuropathy (NAION)
12) Use of any 5-alpha reductase inhibitor, androgens, anti-androgens, any drugs with androgenic or anti-androgenic properties (e.g. spironolactone, flutamide, bicalutamide, cimetidine, metronidazole, progestational agents), anabolic steroids, LHRH agonists/antagonists or other drugs which affect prostate volume, within past 3 months of the screening visit
13) Patient on nitrates or beta-agonists within 2 weeks of screening or who are planning to take during the study
14) Patient using strong inhibitors of CYP3A4 (e.g. ketoconazole, ritonavir, itraconazole), moderate inhibitors of CYP3A4 (e.g. erythromycin), strong or moderate inhibitors of CYP2D6 (e.g. paroxetine, terbinafine), CYP3A4 inducers (e.g. rifampin), GC stimulator (e.g. riociguat) at screening
15) Patients with glycosylated hemoglobin (HbA1c) ≥ 7.5 % at screening
16) Patient with moderate to severe renal impairment (Creatinine clearance < 50 mL/min) and hepatic impairment (AST and ALT ˃ 3 x ULN)
17) Patient with history of HIV and / or Hepatitis B and/ or Hepatitis C
18) Patient with history of bleeding disorders or significant active peptic ulceration
19) Patient with history of cancer or undergoing cancer chemo or radiotherapy
20) Patient having hypersensitivity or any other contraindication to any of the Investigational products
including its components; or history of hypersensitivity reaction to sulfa drugs
21) Patient involved in profession like driving, operating heavy machinery or performing hazardous work
22) Patient who have participated in another Investigational study within the 3 months prior to enrolment in this study
23) Patient with known alcohol or other substance abuse within last one year as per DSM-5 criteria
24) Investigator, study personnel, sponsor representatives and their first degree relatives
Method of Generating Random Sequence
Not Applicable
Method of Concealment
Not Applicable
Blinding/Masking
Not Applicable
Primary Outcome
Outcome
TimePoints
Safety:
1. Proportion of participants with treatment-emergent adverse events (TEAEs)
12 Weeks
Secondary Outcome
Outcome
TimePoints
Efficacy
1. Change in Total International Prostate Symptom Score (IPSS) from baseline [Time frame: 4, 8 and 12 weeks]
2. Change in IPSS storage (Irritative) sub score from baseline [Time frame: 4, 8 and 12 weeks]
3. Change in IPSS voiding (Obstructive) sub score from baseline [Time frame: 4, 8 and 12 weeks]
4. Change in IPSS Quality of Life (QoL) Index from baseline [Time frame: 12 weeks]
5. Change in Qmax from baseline[Time frame: 4, 8 and 12 weeks]
6. Change in PVR volume from baseline [Time frame: 4, 8 and 12 weeks]
7. Change in IIEF-EF (questions 1–5 and 15) score from baseline [Time frame: 4, 8 and 12 weeks]
8. Proportion of patients showing normal erectile function (IIEF-EF score 26) at the end of 12 weeks [Time Frame: Week 12]
04 Weeks, 08 Weeks and 12 Weeks
Target Sample Size
Total Sample Size="173" Sample Size from India="173" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Phase of Trial
Phase 4
Date of First Enrollment (India)
15/06/2022
Date of Study Completion (India)
Applicable only for Completed/Terminated trials
Date of First Enrollment (Global)
Date Missing
Date of Study Completion (Global)
Applicable only for Completed/Terminated trials
Estimated Duration of Trial
Years="1" Months="0" Days="0"
Recruitment Status of Trial (Global)
Not Applicable
Recruitment Status of Trial (India)
Not Yet Recruiting
Publication Details
Nill
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
This will be a prospective, multi-center, single-arm, Phase IV,
open-label study. The study will be conducted at approximately 15 to 25
centers in India, having qualified Investigators. The study will be initiated
only after the receipt of regulatory and EC approval.
Screening period
After obtaining the informed consent, patients will be screened
by undergoing various assessments as mentioned in Schedule of Assessment
(Appendix I). The total duration of study will be of 17 weeks, which includes
5 weeks (maximum) of screening period [inclusive of 28 days of washout
period]. Patients using drugs to treat BPH or medications that could act on
bladder function (alpha blockers, anticholinergics etc.,) or PDE5Is will
undergo a 4-week medication free wash out period before the study treatment.
During washout period if patient is not able to continue without medications
then he will be considered as screened failure. During washout period patient
can continue medications that are not prohibited for the study for acceptable
co-morbid conditions.
Treatment period
Treatment period will be of 12 weeks. Eligible patients will be
given FDC of Tamsulosin HCI PR and Tadalafil (0.4 mg + 5 mg) capsules once
daily during study duration.
The study consists of following visits:
Visit 1 (Day -35 to -1): Screening and 28 days washout period
Visit 5 (Day 84 ± 3 Days) (Week 12): End of Study visit
Patients who are terminating early from the study will be
completing Visit 5 assessments. Visit 5 will be considered as early treatment
(ET)/end of study visit (EOS). The safety and efficacy will be assessed
during the study period as mentioned in Schedule of Assessment.