Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04985669 |
| Other study ID # |
3420 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
Phase 4
|
| First received |
|
| Last updated |
|
| Start date |
August 15, 2021 |
| Est. completion date |
March 2022 |
Study information
| Verified date |
August 2021 |
| Source |
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh |
| Contact |
Md. Reazuddin Danish, MBBS |
| Phone |
01952076155 |
| Email |
reazuddindanish89[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This will be a semi-experimental study on constipation predominant IBS patient. One group of
patient will receive prucalopride 2mg daily and another group of patient will receive
lubiprostone 8 microgram twice daily. IBS-SSS and IBS-QOL score will be recorded at baseline
and at follow up at 3 week and 6 week. Effectiveness of both drug will be evaluated by
comparing the baseline data with data at 3 week and 6 week(IBS-SSS and IBS-QOL).
Description:
Consecutive patients of both sexes age between 18-50 years attended the outpatient department
of Gastroenterology, BSMMU, meeting the inclusion Criteria entered a 2 week screening period.
During this period, patients were required to discontinue all laxative medications. All
participants will be advised to maintain a stable diet with no significant changes in their
consumption of liquids or fiber or in their level of physical activity.
During the screening period, patients accessed and diary system on a daily basis to report
the occurrence and time of all spontaneous bowel movements (SBMs), defined as those that
occurred without the use of rescue medications. If the patient did not experience a SBM for 3
or more consecutive days and needed relief, the study investigator could authorize the
patient to administer a rescue medication. Initial rescue treatment consisted of a 10 mg
bisacodyl. If this was not successful a Fleet enema could then be used. If both of these
treatment options were unsuccessful, an alternative medication could be prescribed after
consultation with the investigator. At the end of the screening period, patients were
assessed by medical history, physical examination, and laboratory tests (CBC, ESR, CRP, RBS,
S. creatinine, S.TSH and ECG) will be done. ECG will be done from cardiology OPD, BSMMU, and
rest of the investigations from Department of Laboratory Medicine, BSMMU. Report will be
noted in the standard data sheet. Any alternative diagnosis if proven by clinical examination
or laboratory investigation will be excluded from the study
The subject will be recruited according to sample size. Selection into two groups will be
performed non probability sampling method. An independent treatment codes and allocation will
be maintained. Patients enrolled in trial were selected to receive either or prucalopride 2
mg once daily at morning before breakfast or lubiprostone 8 mcg twice daily after meal.
Before starting treatment each individual will undergo a baseline assessment during which
demographic data, IBS symptoms and QOL data will be recorded. Each drug was administered
after with at least 8 ounces of water for a period of 6 weeks. A reduction to once-daily
dosing was allowed, at the discretion of the investigator, if the patient experienced nausea
or diarrhea for more than 2 days or if patients experienced other adverse events. During
treatment, patients were prohibited from taking prescription or OTC medications for
constipation.
Non constipation-related prescriptions and other OTC medications were allowed and their usage
was documented as was as any medication change. As in the screening period, the use of rescue
medications was allowed in those who failed to have a spontaneous bowel movement for 3 or
more consecutive days and thus needed relief. During the 6-week study phase, clinic visits
were conducted at weeks 3 and 6 week and phone interviews were performed at 1 week after
starting and 2 week after the end at study period. At each clinic visit, the daily diary
information was reviewed and discussed with the patient, adverse events were recorded,
remaining capsules were collected to assess compliance and assessments of vital signs and
laboratory parameters were performed. Patients also completed the IBS-QOL and IBS-SSS at week
3 and 6 visits. Patients will be asked to return with the strips of the ingested drugs at the
end of the treatment to count & ensure compliance. Any adverse effect due to drugs will also
be noted at the same time.
IBS-SSS is a 5 item tools. It is primarily a measure of IBS symptoms including abdominal pain
and distension as well as bowel satisfaction. This scale evaluates IBS symptoms: abdominal
pain, abdominal distension, stool frequency and consistency and interference with life in
general. The IBS-SSS calculates the sum of these 5 items scored on a visual analogue scale
from 0-100. Determination of severity of each symptoms is determined by patient. The nature
of the items on IBS-SSS is appropriate to be used in clinical trials. The items are summed
and thus the total score can range from 0 to 500 points. IBS severity has the following
defined ranges: mild 75-174, moderate 175-300, and severe > 300
The IBS-QOL questionnaire is a 34-item instruments which assess QOL impairment due to IBS
symptoms. Each item is scored on a five-point scale (1 = not at all, 5 = a great deal) that
represents one of eight dimensions (dysphoria, interference with activity, body image,
health-related worries, food avoidance, social reactions, sexual dysfunction, and
relationships). Items are scored to derive an overall total score of IBS related QOL. To
facilitate score interpretation, the summed total score is transformed to a 0-100 scale
ranging from zero (poor QOL) to 100 (maximum QOL). The QOL instrument will be given to each
patient before treatment is started; the patient will complete the form according to schedule
and all data will be recorded and entered onto a data sheet.
