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| A phase I, single centre, open study to assess the pharmacokinetic profile and safety of a 100 mg Clindamycin Hydrochloride Vaginal Insert (CHVI) in healthy females |
| Source of record | UK Trials |
| ISRCTN | ISRCTN15152571 |
| Date ISRCTN assigned | 04/10/2007 |
| Local reference number(s) | Clin-Gyn-101 |
| Public title | A phase I, single centre, open study to assess the pharmacokinetic profile and safety of a 100 mg Clindamycin Hydrochloride Vaginal Insert (CHVI) in healthy females |
| Scientific title | |
| Acronym | CHVI |
| Disease/condition/study domain | Bacterial Vaginosis |
| Study hypothesis | This study is to confirm the safety, tolerability and the pharmacokinetic profile of the hydrochloride forumation in healthy female volunteers. This treatment is expected to be effective in the treatment of patients diagnosed with Bacterial Vaginosis. Hypothesis: The concentrations of clindamycin (fee base) in plasma at pre-determined time-points. Please note that as of 18/10/2007 the anticipated end date of this trial was extended from 09/10/2007. |
| Design/methodology | A phase I, single centre, non-randomised, non-controlled open study |
| Research ethics review | Ethics approval received from Tayside Committee on Medical Research Ethics B on the 21st August 2007 (ref: 07/S1402/63). |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 1. Healthy female volunteers aged between 18 - 50 years 2. Urine negative for a urinary tract infection 3. Up to date with regular pap smear tests in accordance with local health authority guidelines 4. Agree to refrain from placing anything on the following list in their vagina other than the study drug from the day of admission to the clinical trial unit until completion of the follow-up visit: 4.1. Use of feminine deodorant sprays/products, spermicides*, douches, condoms*, tampons, diaphragms* or any other pharmaceutical or over the counter vaginal product Barrier methods of contraception as indicated above (*) may be resumed following discharge from the clinic (Day 3) 4.2. Vaginal intercourse is permitted except for the 24 hour period prior to admission and during the residential period of the study 5. Written informed consent |
| Participants - exclusion criteria | 1. Volunteers expected to menstruate from Day 0 to Day 6 or during the 48 hours prior to dosing 2. Volunteers who have a vaginal pH of 4.7 or higher and have any other signs or symptoms of infections at screening and prior to Dosing Day 1 3. Volunteers who have any significant history of drug allergies especially to clindamycin or lincomycin 4. Urinary tract infection in the previous 6 months or have a significant history of recurring urinary tract infections 5. Antimicrobial and/or antifungal therapy (systemic or intravaginal) within 14 days of dosing 6. Signs and/or symptoms of vaginal infection or infections within the last month or positive vaginal swab culture (to definite specific pathogens) at screening 7. Known current Sexually Transmitted Infection (STI) to be established by discussion 8. Contraindications for clindamycin per current labelling of markteed intravaginal formulations 9. Diagnosis or treatment in the previous 6 months for Cervical Intra-epithelial Neoplasia (CIN) or cervical carcinoma |
| Patient information material | |
| Anticipated start date | 03/09/2007 |
| Anticipated end date | 09/11/2007 |
| Status of trial | Completed |
| Target number of participants | 10 |
| Interventions | Pre-trial visit: Prior to interventions, written informed consent will be gained. A screening assessment and a compliance check will be performed the day before dosing. Day one: Pre-dose checks, vitals, menstrual history check, a pre-dose Pharmacokinetic (PK) sample and vaginal pH testing will be performed, and a check to see if the volunteer has any signs or symptoms of infection will also be performed. After this, the study drug (100 mg Clindamycin Hydrochloride Vaginal Insert) will be administered (dosing period = 24 hours). Post insertion checks will include comfort questionnaires, PK blood samples, vitals and vaginal pH. The study drug will be removed at 24 hours and a urine sample for urinalysis will be taken. Day two: PK blood samples will be taken. Days 3, 4, 5 and 6: PK blood sample, vitals and urine sample for urinalysis information will be taken. Adverse Events (AEs) and concomitant medication checks will be performed throughout the trial. Post-trial visit: Vitals, Electrocardiogram (ECG), safety bloods and urine samples, urine for pregnancy testing and a physical examination will be performed. |
| Primary outcome measure(s) | The concentrations of clindamycin (free base) in plasma at pre-determined time-points. |
| Secondary outcome measure(s) | 1. Assessments of all adverse events reported 2. Assessment of tolerability by review of completed comfort questionnaires 3. Assessment of vaginal pH at specified time-points 4. Measurements of residual amounts of clindamycin in used CHVI to calculate the remaining dose of clindamycin in order to determine the amount of drug released from the insert |
| Sources of funding | Controlled Therapeutics (Scotland) Ltd (UK) |
| Sponsor name | Controlled Therapeutics (Scotland) Ltd (UK) |
| Sponsor details | 1 Redwood Place Peel Park Campus East Kilbride United Kingdom G74 5PB |
| Sponsor website | http://www.ctscotland.com |
| Contact name | Dr Brian Sanderson |
| Contact details | Drug Development Solutions Limited Ninewells Hospital and Medical School Dundee United Kingdom DD1 9SY |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN15152571 |
| Date last extracted from ISRCTN register | 17/04/2008 |
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