Clinical acceptability study in patients suffering from acute hemorrhoidal disease comparing micronized purified flavonoid fraction (MPFF) 1000 mg tablet, to MPFF 500 mg tablet
| ISRCTN | ISRCTN28639953 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN28639953 |
| Protocol serial number | CL3-05682-108 |
| Sponsor | Institut de Recherches Internationales Servier (France) |
| Funder | Institut de Recherches Internationales Servier (France) |
- Submission date
- 05/05/2014
- Registration date
- 06/06/2014
- Last edited
- 18/04/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Not provided at time of registration and not expected to be available in the future
Contact information
Scientific
Federal State Institution 'State Scientific Center of Coloproctology' of Ministry of Health of Russian Federation
2, Salyama Adilya Street
Moscow
117997
Russian Federation
| clinicaltrials@servier.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | International multicenter double-blind randomized parallel-group study |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Clinical acceptability study of micronized purified flavonoid fraction 1000 mg tablets and micronized purified flavonoid fraction 500 mg tablets after 7 days of treatment followed by a follow-up period of 7 days in patients suffering from acute hemorroidal disease (HD) |
| Study objectives | To demonstrate the clinical acceptability of MPFF 1000 mg and MPFF 500 mg tablets in patients suffering from hemorrhoidal disease during a 7-day treatment period, followed by follow-up period of 7 days. |
| Ethics approval(s) | Ethics approval was obtained before recruitment of the first participants |
| Health condition(s) or problem(s) studied | Hemorrhoidal disease |
| Intervention | All participants will receive 3 g/day of MPFF during 4 days and 2 g/day of MPFF during the 3 following days. Participants will be randomly allocated to receive this dose in the form of either 500 mg tablets or 1000 mg tablets. After the 7 days of treatment there will be a follow-up period of 7 days |
| Intervention type | Other |
| Primary outcome measure(s) |
Safety (clinical acceptability) assessed at each visit (day 0, day 7, day 14). Safety assessment takes into account adverse events, weight, sitting blood pressure and heart rate, bleeding cessation evaluation by a 4-point scale, pain evaluation by Visual Analog Scale and laboratory examination |
| Key secondary outcome measure(s) |
N/A |
| Completion date | 13/06/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Sex | All |
| Target sample size at registration | 150 |
| Key inclusion criteria | 1. Male or female patient aged 18 to 75 years old (inclusive) 2. Out-patient 3. Suffering from acute and non-complicated hemorrhoidal episode (acute pain with oedema assessed by a Visual Analog Scale and/or bleeding assessed by a 4-point scale) |
| Key exclusion criteria | 1. Pregnancy, breastfeeding or possibility of becoming pregnant 2. Complicated hemorrhoidal disease (requiring surgery, stage IV prolapsed hemorrhoids, anal fissure, associated infection), patients presenting other anal bleeding pathologies 3. Laser therapy, anal surgery, canal radiation before inclusion |
| Date of first enrolment | 16/12/2013 |
| Date of final enrolment | 13/06/2014 |
Locations
Countries of recruitment
- Russian Federation
- Serbia
Study participating centre
117997
Russian Federation
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from https://clinicaltrials.servier.com/ if a Marketing Authorisation has been granted after 2014. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/11/2016 | Yes | No | |
| Basic results | No | No | |||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
18/04/2018: Internal review
28/03/2018: The publication and dissemination plan has been changed.
19/12/2017: publication reference added.
04/12/2017: results summary added.
09/05/2017: contact email address added.
03/07/2014: the anticipated end date was changed from 15/07/2014 to 13/06/2014.
