Clinical Trial Assessing the Efficacy and Safety of Hépar® in Chronic Constipation

NCT03348007 | Completed

• 1 other identifier: 2014-A00948-39
• Study Type: interventional
• Target: 262
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Constipation - Functional

Outcome Measures

Primary Outcomes (1)

• Gastro-intestinal transit

  The primary study endpoint will be the gastro-intestinal transit change measured by the percentage of responder subjects defined as a composite score of the two following Rome III criteria: number of stools ≥ 4 or an increase of 2 stools/week and stools consistency with less than 25% of lumpy to hard stools reviewed by an independent expert on objectified criteria (photography)

  day 14

Secondary Outcomes (3)

• Defecation frequency

  day 14

• Stool consistency

  day 14

• Intensity/severity of the patient's constipation

  day 14

Study Arms (2)

HEPAR

EXPERIMENTAL

1L of Hépar + 0.5L of low-mineral water (Hépar group).

Other: Taking two kinds of mineral water

VITTEL Bonne Source

ACTIVE COMPARATOR

1.5L of low-mineral water (Vittel Bonne Source, control group)

Other: Taking two kinds of mineral water

Interventions

Taking two kinds of mineral water OTHER

1.5L of low-mineral water (Vittel Bonne Source, control group) or 1L of Hépar + 0.5L of low-mineral water (Hépar group).

HEPAR; VITTEL Bonne Source

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women, aged 18 to 60.
• Outpatients.
• Diagnosis of constipation according to the Rome III criteria Symptoms ≥3 months Onset ≥6 months prior to diagnosis
• a. Presence of ≥2 of the following symptoms for at least 25% of defecations: straining, lumpy or hard stools, sensation of incomplete evacuation, sensation of ano-rectal obstruction/blockage, manual maneuvers to facilitate defecation (e.g., digital evacuation, support of the pelvic floor), \<3 defecations/week and b. Loose stool rarely present without use of laxative and c. Insufficient criteria for Inflammatory Bowel Syndrome with constipation (IBS-C)
• Easy access to toilet at work or elsewhere.
• Regularly consumption of vegetables and fruits.
• Physical activity 2 or 3 times a week.
• Consumption of 1.0 L to 1.5 L of water per day.
• Signed informed consent.
• Ability to follow the study instructions.
• Health insurance coverage.

You may not qualify if:

• Current pregnancy.
• Severe or acute disease likely to interfere with the results of the study or to be life-threatening.
• History of digestive disease, digestive malformation.
• Metabolic disease.
• Dysfunction of phospho-calcium metabolism.
• History of renal disease (renal insufficiency etc.) or cardio-vascular disease (cardiac insufficiency...), respiratory disease, neural disease.
• Subject on local or general treatment (prescribed drugs, food supplements etc.) likely to interfere with evaluation of the study parameters, including hydration status and transit.
• Subject who refuses to sign the declaration of informed consent.
• Subject not available for the entire duration of the study.
• Subject having a bad acceptance to Hépar® water.
• Subject being currently treated with drugs that can interact on digestive motility: paraffin, mucilages, pro or prebiotics, lactulose, lactitol, PEG.
• Subject has participated in a clinical trial within 3 months prior to baseline visit.

Sponsors & Collaborators

• Quanta Medical: lead

Study Sites (1)

Quanta Medical

Rueil-Malmaison, 92500, France

Location

Study Officials

• Baudouin TCHAKONTE, MD

  44340 Bouguenais France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: November 13, 2017
• First Posted: November 20, 2017
• Study Start: January 30, 2015
• Primary Completion: July 22, 2016
• Study Completion: July 22, 2016
• Last Updated: November 27, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)