Vaginal InfectionsPhase 4NCT01697826
Comparison of Two Topical Formulations Containing Clindamycin and Clotrimazole in Patients With Vaginal Infections
A Phase 4 study testing ClinSupV3 -soft gelatin capsule and ClinSupV3ER- Extended release tablet in people with Vaginal Infections, run by Dr Bharti Daswani at 1 site in India.
Trial summary
Randomized, Parallel Group, Active Controlled Trial to compare effectiveness and tolerability of 2 different vaginal formulations containing 200mg clotrimazole and clindamycin phosphate equivalent to 100mg clindamycin for 3 days in women clinically diagnosed to have infective vaginitis. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Vaginal Infections
- What is being tested?
- ClinSupV3 -soft gelatin capsule and ClinSupV3ER- Extended release tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteIndia
- Study dates
- Apr 2011to Sep 2011
- Phase
- Phase 4
- 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 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women with symptoms of vaginal discharge and/or odor and a clinical diagnosis of vaginitis of infective origin [based on symptoms and signs on per speculum examination]
- Age at least 18 years
- Capable of giving written informed consent
- Agree to no intercourse for 8 days from the day of start of treatment
- Agree not to douche or use any intravaginal products during the study period (including tampons, medications and devices)
Who cannot join
- Post-menopausal women
- Menstruating at diagnosis
- Pregnancy
- Any antifungal or antibiotic use 14 days prior to enrolment
- Use of oral or intravaginal antibiotics within the past 2 weeks
- Immunosuppressive drug within 4 months
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- Presence of vaginal / vulval ulcer
- Presence of any other vulval, vaginal or medical condition, including cervical neoplasia/ treatment that might confound treatment response
- Inability to keep return appointments
- History of hypersensitivity to clotrimazole, clindamycin or lincomycin
- History of regional enteritis, ulcerative colitis or antibiotic associated colitis
- Significant disease or acute illness that in the Investigators assessment could complicate the evaluation
- Intrauterine Device
Trial locations and contacts
1 site in 1 country.
India1 site
BJ Govt. Medical College & Sassoon General Hospitals, Pune
Pune, Maharashtra, 411001
About this study
Official title: A Comparative Open Labeled Clinical Study to Evaluate the Efficacy and Tolerability of Two Different Intravaginal Formulations Containing a Combination of Clindamycin and Clotrimazole in Vaginal Infections
Randomized, Parallel Group, Active Controlled Trial to compare effectiveness and tolerability of 2 different vaginal formulations containing 200mg clotrimazole and clindamycin phosphate equivalent to 100mg clindamycin for 3 days in women clinically diagnosed to have infective vaginitis.
Read the detailed description
- This is a Randomized, Comparative, Prospective, Open label, Single center study to compare the 3 day treatment course of intravaginal soft gelatin capsule containing clindamycin and clotrimazole versus intravaginal ER tablets of clindamycin and clotrimazole in patients with vaginal discharge and clinical diagnosis of bacterial, trichomonal, candidal or mixed vaginitis with respect to efficacy and tolerability; and to study the in vitro drug release pattern of intravaginal soft gelatin capsule and intravaginal ER tablets containing clindamycin and clotrimazole.
- The study will be conducted in B.J. Medical College \& Sassoon General Hospitals, Pune. The study will be completed in 60 patients [30 patients in each group].
- The primary outcome measure is absence of any clinical sign suggestive of infective vaginitis and a vaginal swab that is negative for bacterial, trichomonal or candidal vaginitis at 8th day after start of treatment [Effectiveness in inducing a remission].
- The secondary outcome measures will be
- absence of any clinical sign suggestive of infective vaginitis and
- a vaginal swab that is negative for bacterial, trichomonal or candidal vaginitis at 29th day after start of treatment [Effectiveness in maintaining a remission] and ability to complete the 3day course without any break or experiencing intolerable side effects [Tolerability].
- Conditions
- Vaginal Infections
- Being tested
- ClinSupV3 -soft gelatin capsule, ClinSupV3ER- Extended release tablet
- Keywords
- Clindamycin, Clotrimazole, Vaginal formulation, Bacterial vaginosis, Candidiasis, Trichomoniasis, Mixed vaginitis, Infective vaginitis
- Medical subject headings
- Vaginitis, Vaginosis, Bacterial, Candidiasis, Trichomonas Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClinSupV3 -soft gelatin capsuleDrug
Also called Clindamycin plus Clotrimazole
3 day treatment with intravaginal formulation containing 100mg Clindamycin and 200mg clotrimazole
ClinSupV3ER- Extended release tabletDrug
Also called Clindamycin plus Clotrimazole
3 day treatment with intravaginal formulation containing 100mg Clindamycin and 200mg Clotrimazole
| Study group | Role | What they receive |
|---|---|---|
| ClinSupV3 -soft gelatin capsule | Active comparator | Soft gelatin capsule containing 100mg Clindamycin and 200mg clotrimazole administered per vaginally for 3 consecutive days Receives: Drug: ClinSupV3 -soft gelatin capsule |
| ClinSupV3ER- Extended release tablet | Active comparator | ER tablets containing 100mg clindamycin and 200mg clotrimazole administered per vaginally for 3 consecutive days. Receives: Drug: ClinSupV3ER- Extended release tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome measure for Global effectiveness
Number of patients showing resolution of clinical signs suggestive of infective vaginitis and a vaginal swab that is negative for bacterial, trichomonal or candidal vaginitis
Measured: On 8th day after start of treatment
Secondary outcomes (2)
Secondary outcome measures for Global effectiveness
Number of patients showing absence of clinical signs suggestive of infective vaginitis and a vaginal swab that is negative for bacterial,trichomonal or candidal vaginitis
Measured: 29th day after initiation of treatment
Secondary outcome measures for tolerability
Number of patients that are able to successfully complete the 3 day treatment course without a break or experiencing intolerable side-effects
Measured: 8th day after start of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2012 (estimated)
- Study startApr 2011
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaginal InfectionsStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr Bharti Daswani
- Collaborators
- Resilient Cosmeceuticals Pvt. Ltd, Pune
- Responsible party
- Sponsor-investigator, Dr Bharti Daswani, Daswani, Bhart, M.D.
- Investigators
- Bharti R Daswani, MD, PhD, Principal investigator, BJ Govt Medical College & Sassoon General Hospitals, Pune
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01697826
- Sponsor's protocol ID
- ND1210132-34
- Other IDs
- CTRI/2011/04/001698
- Status last verified
- Sep 2012
- First submitted
- 29 Sep 2012
- Last updated
- 2 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Open Labeled Clinical Study to Evaluate the Efficacy and Tolerability of Two Different Intravaginal Formulations Containing a Combination of Clindamycin and Clotrimazole in Vaginal Infections
- ClinicalTrials.gov ID
- NCT01697826
- Acronym / sponsor ID
- ND1210132-34
- Conditions
- Vaginal Infections
- Keywords
- Clindamycin, Clotrimazole, Vaginal formulation, Bacterial vaginosis, Candidiasis, Trichomoniasis, Mixed vaginitis, Infective vaginitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Dr Bharti Daswani
- Collaborators
- Resilient Cosmeceuticals Pvt. Ltd, Pune
- Study start
- Apr 2011
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 2 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Randomized, Parallel Group, Active Controlled Trial to compare effectiveness and tolerability of 2 different vaginal formulations containing 200mg clotrimazole and clindamycin phosphate equivalent to 100mg clindamycin for 3 days in women clinically diagnosed to have infective vaginitis.
Detailed description
- This is a Randomized, Comparative, Prospective, Open label, Single center study to compare the 3 day treatment course of intravaginal soft gelatin capsule containing clindamycin and clotrimazole versus intravaginal ER tablets of clindamycin and clotrimazole in patients with vaginal discharge and clinical diagnosis of bacterial, trichomonal, candidal or mixed vaginitis with respect to efficacy and tolerability; and to study the in vitro drug release pattern of intravaginal soft gelatin capsule and intravaginal ER tablets containing clindamycin and clotrimazole.
- The study will be conducted in B.J. Medical College \& Sassoon General Hospitals, Pune. The study will be completed in 60 patients [30 patients in each group].
- The primary outcome measure is absence of any clinical sign suggestive of infective vaginitis and a vaginal swab that is negative for bacterial, trichomonal or candidal vaginitis at 8th day after start of treatment [Effectiveness in inducing a remission].
- The secondary outcome measures will be
- absence of any clinical sign suggestive of infective vaginitis and
- a vaginal swab that is negative for bacterial, trichomonal or candidal vaginitis at 29th day after start of treatment [Effectiveness in maintaining a remission] and ability to complete the 3day course without any break or experiencing intolerable side effects [Tolerability].
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ClinSupV3 -soft gelatin capsule | Active comparator | Drug: ClinSupV3 -soft gelatin capsuleSoft gelatin capsule containing 100mg Clindamycin and 200mg clotrimazole administered per vaginally for 3 consecutive days |
| ClinSupV3ER- Extended release tablet | Active comparator | Drug: ClinSupV3ER- Extended release tabletER tablets containing 100mg clindamycin and 200mg clotrimazole administered per vaginally for 3 consecutive days. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Women with symptoms of vaginal discharge and/or odor and a clinical diagnosis of vaginitis of infective origin [based on symptoms and signs on per speculum examination]
- Age at least 18 years
- Capable of giving written informed consent
- Agree to no intercourse for 8 days from the day of start of treatment
- Agree not to douche or use any intravaginal products during the study period (including tampons, medications and devices)
Key exclusion criteria (13 listed)
- Post-menopausal women
- Menstruating at diagnosis
- Pregnancy
- Any antifungal or antibiotic use 14 days prior to enrolment
- Use of oral or intravaginal antibiotics within the past 2 weeks
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 |
|---|---|---|
| ClinSupV3 -soft gelatin capsuleAlso: Clindamycin plus Clotrimazole3 day treatment with intravaginal formulation containing 100mg Clindamycin and 200mg clotrimazole | Drug | ClinSupV3 -soft gelatin capsule |
| ClinSupV3ER- Extended release tabletAlso: Clindamycin plus Clotrimazole3 day treatment with intravaginal formulation containing 100mg Clindamycin and 200mg Clotrimazole | Drug | ClinSupV3ER- Extended release tablet |
Primary outcome
Primary outcome measure for Global effectiveness
Time frame: On 8th day after start of treatment
Number of patients showing resolution of clinical signs suggestive of infective vaginitis and a vaginal swab that is negative for bacterial, trichomonal or candidal vaginitis
2 secondary outcomes
Secondary outcome measures for Global effectiveness
Time frame: 29th day after initiation of treatment
Secondary outcome measures for tolerability
Time frame: 8th day after start of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2012.
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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.
Bharti R Daswani, MD, PhD principal investigator
BJ Govt Medical College & Sassoon General Hospitals, Pune
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ClinSupV3 -soft gelatin capsule and ClinSupV3ER- Extended release tablet in people with Vaginal Infections, run by Dr Bharti Daswani at 1 site in India.
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 5 inclusion and 13 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 2 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Primary outcome measure for Global effectiveness (time frame: On 8th day after start of treatment). 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 2 Oct 2012.