Efficacy of Macrogol 4000 with daily oral magnesium oxide in chronic constipation refractory to MgO or with hypermagnesemia.

JRCT ID: jRCT1051190047

Registered date:10/09/2019

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: chronic constipation
• Date of first enrollment: 10/09/2019
• Target sample size: 50
• Study type: Interventional
• Intervention(s): To take Macrogol 4000

Outcome(s)

• Primary Outcome: patient satisfaction

Secondary Outcome

defecation frequency
serum magnesium level
The Bristol Stool Form Scale
modified Constipation Scoring System (mCCS)
Patient Assessment of Constipation Quality of Life Questionnaire (PAC-QOL)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

In order to be eligible for participation in this study, the patient must:
1.be given adequate explanation about the study, fully understand it, and voluntarily agree to participate by giving written informed consent.
2.be able and willing to follow instructions, make protocol-defined visits, undertake protocol-defined assessments, and report his/her symptoms.
3.be 20 years and over of age at the point of informed consent.
4.be diagnosed as chronic constipation

Exclude criteria

The patient must be excluded from participating in the study if the patient:
1.is complicated by a severe cardiopulmonary disorder.
2.has any condition in which one or both of the study drugs (Macrogol 4000) is contraindicated according to the contraindications listed in the drugs' package inserts, or has past history of hypersensitivity to any components of the drugs.
3.participated in other clinical trial and received other investigational drugs within one month prior to the start (first dose) of study treatment of this study.
4.took Macrogol 4000 within 3 months of participation in this study
5.is lactating or potentially pregnant.
6.is considered to be inappropriate to participate in the study for any other reason by the PI/subinvestigator.

Related Information

• Primary Sponsor: Okuyama Masatsugu