| CTRI Number |
CTRI/2012/01/002370 [Registered on: 24/01/2012] Trial Registered Prospectively |
| Last Modified On: |
20/10/2012 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Clinical trial of tablet containg two medicines - Dapoxetine and Sildenafil - for the treatment of co-existing Erectile Dysfunction and Premature Ejaculation. |
|
Scientific Title of Study
|
Clinical study to evaluate efficacy and safety of Fixed Dose Combination of Dapoxetine Hydrochloride and Sildenafil Citrate Tablet in treatment of co-existing Erectile Dysfunction and Premature Ejaculation. |
| Trial Acronym |
DAP-SIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| EPL/2010/DAP-SIL/01; Version 01 dated 20.08.2010 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anand V Tendulkar |
| Designation |
Manager - Medical |
| Affiliation |
Emcure Pharmaceuticals Ltd, |
| Address |
Survey No. 255/2, Phase I, Rajiv Gandhi IT Park,
MIDC, Hinjewadi, Pune
Pune
MAHARASHTRA
411057
India |
| Phone |
020-39821000 |
| Fax |
020-39821019 |
| Email |
Anand.Tendulkar@emcure.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anand V Tendulkar |
| Designation |
Manager - Medical |
| Affiliation |
Emcure Pharmaceuticals Ltd, |
| Address |
Survey No. 255/2, Phase I, Rajiv Gandhi IT Park,
MIDC, Hinjewadi, Pune
Pune
MAHARASHTRA
411057
India |
| Phone |
020-39821000 |
| Fax |
020-39821019 |
| Email |
Anand.Tendulkar@emcure.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anand V Tendulkar |
| Designation |
Manager - Medical |
| Affiliation |
Emcure Pharmaceuticals Ltd, |
| Address |
Survey No. 255/2, Phase I, Rajiv Gandhi IT Park,
MIDC, Hinjewadi, Pune
Pune
MAHARASHTRA
411057
India |
| Phone |
020-39821000 |
| Fax |
020-39821019 |
| Email |
Anand.Tendulkar@emcure.co.in |
|
|
Source of Monetary or Material Support
|
| Emcure Pharmceuticals Ltd, Pune |
|
|
Primary Sponsor
|
| Name |
Emcure Pharmceuticals Ltd Pune |
| Address |
Survey No. 255/2, Rajiv Gandhi IT Park,Phase I, MIDC, Hinjwadi,Pune-411 057
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 5 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rohan Kusumgar MDPsy |
Aashray Clinic |
114, Span Trade Centre, Opposite Kochrab Aashram,
Near Paldi Cross Road, Ellisbridge, Ahmedabad
Ahmadabad
GUJARAT |
079-26577914
dr_rohan291@rediffmail.com |
| Dr Hemang Desai MD DPM |
Dr. Hemang Desais Clinic |
306, Sangini Complex,
Near. Doctor House,,Piramal Garden, Ellis Bridge,-380006
Ahmadabad
GUJARAT |
079-26465722
niyatide@gmail.com |
| Dr Vinesh D Chandramaniya MBBS DPM MD |
Prime Hospital |
Gate No. 6, Opposite Holy Angle School, Malwani, Malad (West)
Mumbai (Suburban)
MAHARASHTRA |
022-22908654
drvinesh123@gmail.com |
| Dr Mrugesh Vaishnav MDPsy |
Samvedana Hospital |
103, 104 Karnavati Hospital Building, Opposite Town Hall, Ellisbridge, Ahmedabad - 380006
Ahmadabad
GUJARAT |
079-26578889
drmrugesh@rediffmail.com |
| Dr Ketan Parmar MD DPM FIPS |
Swaminarayan Clinic & Nursing Home |
B/104, Priya Aprtments, Main Carter Road, Borivali (East),
Mumbai
Mumbai (Suburban)
MAHARASHTRA |
022-28644218
drketanparmar@vsnl.net |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| Ethiclin Independent Ethics Committee for Dr. Hemang Desai |
Approved |
| IBIOME IEC for Dr. Mrugesh Vaishnav |
Approved |
| IEC COMSARTs for Dr. Ketan Parmar |
Approved |
| IEC COMSARTs for Dr. Vinesh Chandramaniya |
Approved |
| Indepndent Ethics Committee for Dr. Rohan Kusumgar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Co-existing Erectile Dysfunction and Premature Ejaculation, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Fixed dose combination of Dapoxetine Hydrochloride 30 mg and Sildenafil Citrate 50 mg Tablet |
One tablet of Fixed Dose Combination is to be taken approximately 1 hour prior to sexual activity. (Maximum dosing frequency is once in every 24 hours). Duration of treatment is 4 weeks. |
| Comparator Agent |
Placebo tablet similar to TEST tablet |
One tablet of the placebo similar to Test is to be taken approximately 1 hour prior to sexual activity (Maximum dosing frequency is once in every 24 hours. Duration of treatment is 4 weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
64.00 Year(s) |
| Gender |
Male |
| Details |
1.Male subjects between 18 to 64 years of age.
2.Male subjects with stable, monogamous, heterosexual relationship for at least 6 months and expected/planned to maintain this relationship for duration of study.
3.Subjects meeting with diagnostic criteria for erectile dysfunction (as per the international index of erectile function (IIEF) score lesser than or equal to 25; as specified in Urology 1999, 54: 346-351).
4.Subjects meeting with diagnostic criteria for premature ejaculation (PE score greater than or equal to 11) as specified in article published in European Urology 2007, 52: 565-573.
5.Subject and his partner agreeing to attempt sexual intercourse 2 times/ week.
6.Subject willing to give written informed consent and willing to comply with trial protocol.
|
|
| ExclusionCriteria |
| Details |
1.Previous events or other conditions associated with premature ejaculation/erectile dysfunction including but not limited to spinal trauma or pelvic surgery.
2.Subjects with genital anatomical deformities including but not limited to penile deformities.
3.Subjects with erectile dysfunction or premature ejaculation due medication withdrawal.
4.Sexual dysfunction in female partner, painful intercourse, partners with decreased interest in intercourse or other forms of sexual dysfunction.
5.Subjects with major psychiatric illness or previous suicidal attempts.
6.Subjects with history of epilepsy
7.Subjects with history of stroke, myocardial infraction, heart failure, unstable angina, life-threatening arrhythmia and hypotension with in past 6 months.
8.Subjects for whom sexual activity is inadvisable because of their underling disease status.
9.Subject is a known case of autonomic neuropathy, retinitis pigmentosa, bleeding disorders, sickle cell anemia and active peptic ulcer disease.
10.Subjects with significant and uncontrolled hematological/metabolic/ endocrinologial/respiratory/cardiovascular/neurological/psychiatric/liver/kidney diseases.
11.Subjects with resting hypotension (BP 90/50) or hypertension ( BP 170/110)
12.Subjects with history of hypersensitivity to SSRI, SNRI, phosphodiesterase inhibitors and constituent of test product.
13.Subjects with cardiac arrhythmia or any clinically significant abnormality on ECG.
14.Subjects with previous history of bone marrow depression.
15.Subjects taking concurrent drug therapies OR within last 14 days of discontinuing treatment with : Monoamine oxidase inhibitor (MAOIs), Thioridazine, Selective serotonin reuptake inhibitor (SSRI), selective-norepinephrine reuptake inhibitor (SNRI), serotonergic medicinal/herbal products, tricyclic antidepressants, and atypical antipsychotics
16.Subjects taking concurrent treatment of: nitrates, alpha blockers, vosodilators, ketoconazole, itraconazole, ritonavir, saquinavir, telithromycin, nefazadone, nelfinavir, atazanavir, cimetidine, erythromycin, clarithromycin, fluconazole, amprenavir, fosamprenavir, aprepitant, verapamil, diltiazem, any vasodilators, antiplatelet, anticoagulants, dapoxetine, PDE5 inhibitors, alcohol and any other recreational drug.
17.Use of other form of therapy (Pharmacological/ Behavioral) for erectile dysfunction/ premature ejaculation.
18.Subjects who will receive some other drug during the study besides that in the protocol that could alter the pharmacokinetic/ pharmacodynamic profile of the study drug.
19.Subjects with alcohol or drug abuse.
20.Any condition that, in the opinion of the investigator, does not justify the patients inclusion in the study.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Responder rate |
After 2 weeks and 4 weeks of treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) Patient reported outcome measures for premature ejaculation profile
2) Clinical Global impression for change in premature ejaculation
3) Improvement in premature ejaculation (PE) score
4) Improvement in International Index of Erectile Function (IIEF)
5) Improvement in Sexual Health Inventory for Male (SHIM)
6) Improvement in qualitative scale for subjective assessment of Erectile Response published
7) Clinical Global impression for change in erectile dysfunction |
At baseline, after 2 and 4 weeks of therapy |
8) Percent of the subjects experiencing any drug related adverse event as evaluated and recorded by the investigator
9) Subject’s global assessment about the tolerability of the drug
10)Physician’s global assessment about the tolerability of the drug
11) Lab reports & ECG to evaluate any deviation from normal values |
At baseline, after 2 & 4 weeks of therapy
|
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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 3 |
|
Date of First Enrollment (India)
|
27/01/2012 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Applicable |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This multicentric, double-blind, randomized, clinical trial is planned to evaluate efficacy and safety of Fixed Dose Combination of Dapoxetine Hydrochloride and Sildenafil Citrate Tablet in treatment of co-existing Erectile Dysfunction and Premature Ejaculation. Subjects satisfing inclusion and exclusion criteria will be randomized to 3:1 ratio to study and reference group respectively. Baseline laboratory investigations and ECG will be done. Subjects will be evaluated for primary and seconady efficacy variables at basline, after 2 weeks and after 4 weeks of therapy. Laboratory investigations and ECG will be done after 4 weeks of therapy. |