Clinical Trial Assessing the Efficacy and Safety of Hépar® in Chronic Constipation
Condition: Constipation - Functional
MeSH terms: Constipation
Study type: Interventional

Summary: 
      The study objectives are to evaluate the efficacy and safety of a 2-week daily intake of 1L
      Hépar® natural mineral water rich in magnesium sulphate compared to a control natural mineral
      water in the treatment of the constipation symptoms in women outpatients.
    

Detailed description: 
      Healthy patients meeting all of the following criteria were included in the study: i) female
      outpatient aged 18 to 60, ii) with a diagnosis of functional constipation according to the
      Rome III criteria for 3 months or more, iii) without any laxative drug for 3 days prior to
      inclusion, iv) having easy access to toilet, v) regularly eating vegetables and fruits, vi)
      having physical activity, reasonable walking periods or exercise 2 or 3 times a week and vii)
      drinking 1.5±0.5L of water /day. Patients who presented any of the following criteria were
      excluded from the study: i) known unsatisfaction to Hépar, ii) concomitant treatment or
      disease (current or past) likely to interfere with evaluation of the study parameters and
      iii) documented pregnancy. The study was conducted by 28 city-based general practitioners
      located throughout France.

      After a screening visit, patients followed a washout during 7 to 9 days before inclusion.
      Patients had to stop any drug treatment liable to interfere with transit and drink 1.5 litres
      per day of a low-mineral spring water (Nestlé Purelife, Nestlé Waters, France). At the
      inclusion visit, patients were randomized to the control or Hépar group according to the
      chronological order of inclusion and to a predetermined randomization list in balanced blocks
      of 4 treatment units (SAS® software). The randomization list was prepared in advance by the
      statistician from the society in charge of the logistic of bottles, and secured in an
      electronic file with restricted access. Two sets of sealed envelopes kept by the investigator
      and the study manager in a secure and locked place were generated to contain the patient's
      randomization number and allocated group. The investigator could break the blinding in case
      of absolute emergency and in accordance with the sponsor. The follow-up visit was performed
      15 to 17 days following inclusion.

      Patients had to drink 1.5L per day from day 1 to day 14. Depending of the randomization, they
      drank either 1.5L of low-mineral water (Vittel Bonne Source, control group) or 1L of Hépar +
      0.5L of low-mineral water (Hépar group).

      During the screening visit (V0), the physician collected sociodemographics, previous medical
      history and history of the constipation episode (Rome III criteria), onset of symptoms,
      abdominal pain on a 100 mm VAS, dietary habits, physical activities and previous and current
      treatments. The patient was provided with a self-evaluation e-diary to collect: i) the number
      and type of stools (Bristol Scale); ii) abdominal pain, iii) physical activity and iv) drug,
      water, beverage and food consumption during washout.

      At inclusion (V1), the physician collected: i) the weekly number and type of stools, ii) Rome
      III criteria, iii) AEs, iv) ability to complete the e-diary, v) compliance to the washout
      treatment (count of unused bottles), and vi) use of rescue medication over the past week.

      During the final visit (V2), the physician collected: i) the weekly number and type of
      stools, ii) Rome III criteria, iii) AEs, iv) compliance to the treatment (count of unused
      bottles) and v) use of rescue medication over the past two weeks.

      For the washout and the treatment periods, the type of stools was assessed directly by the
      patient on the e-diary and secondarily by an independent expert, based on the photographs the
      patient had to make of each of their stools.
    

Intervention name(s): Taking two kinds of mineral water
Intervention type(s): Other
Intervention description(s): 1.5L of low-mineral water (Vittel Bonne Source, control group) or 1L of Hépar + 0.5L of low-mineral water (Hépar group).
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a multicenter, randomized (2-arm), double-blind, comparative study versus weakly mineralized water (placebo) in women with functional constipation (Rome Criteria III).
During the selection visit functional constipation will be evaluated by retrospective examination over the previous 3 months according to the diagnostic criteria for functional constipation in Rome III. During the 7 to 9 days prior to randomization, the patients selected by the investigators will observe a period of Wash out and will have to drink 1.5l of Nestlé PureLife® (low mineral water) water per day and inform them daily about their symptomatology ( stool frequency, abdominal pain aspect), their water intake and rescue laxative treatment.
Wash-out period concerned previous taking of laxatif drugs
Masking: Double (Participant, Investigator)
Primary purpose: Treatment