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Constipation clinical trials

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NCT ID: NCT00584571 Completed - Clinical trials for Rectal Hypersensitivity

SAT vs Escitalopram for Rectal Hypersensitivity

Start date: December 2007
Phase: Phase 2
Study type: Interventional

Constipation is a common digestive disorder. After excluding dietary factors, drugs and other secondary causes, at least three broad pathophysiologic subtypes are recognized- dyssynergic defecation, constipation-predominant irritable bowel syndrome (IBS-C) and slow transit constipation (STC), all predominantly affect women and elderly. Many patients also demonstrate abnormal rectal perception with both rectal hyposensitivity and hypersensitivity being common. Recent surveys show that most constipated patients are dissatisfied with current therapy. Also, constipated patients showed significant psychological dysfunction and impaired quality of life. OBJECTIVE: To investigate a novel biofeedback technique of improving rectal hypersensitivity. METHODS: A large compliant balloon attached to a barostat was placed in the rectum in 8 patients with rectal hypersensitivity (urgency/pain threshold <30 mm Hg). Sensory deconditioning was performed by incremental balloon distensions (1-2 mmHg) until normal thresholds were reached.

NCT ID: NCT00583609 Completed - Constipation Clinical Trials

A Pilot Study of a New PEG3350 Dose Formulation For Use in Constipated Children

Start date: September 2007
Phase: Phase 4
Study type: Interventional

To evaluate the patient acceptance of a new PEG3350 dose formulation in children currently treated with PEG3350 powder for treatment of constipation.

NCT ID: NCT00583154 Completed - Constipation Clinical Trials

A Pilot Efficacy Evaluation of BLI-801 as a Laxative in Constipated Adults

Start date: October 2007
Phase: Phase 2
Study type: Interventional

To compare the safety and efficacy of BLI-801 administered at 4 dose levels in constipated adults.

NCT ID: NCT00577499 Terminated - Cystic Fibrosis Clinical Trials

Effect of Lubiprostone on Nutritional Status and Pulmonary Function in Adults With Cystic Fibrosis

Start date: October 2007
Phase: N/A
Study type: Observational

Cystic fibrosis (CF) results in thickened secretions in multiple organ systems including the lungs and gastrointestinal (GI) tract. Patients commonly suffer from nutritional deficiency, and achieving and maintaining adequate nutrition is an important goal of therapy because it is positively correlated with lung function. Lubiprostone activates chloride channels in the GI tract. Because its mechanism of action closely parallels the disease pathology, lubiprostone has the potential to provide GI benefits beyond the relief of constipation. This project is an observational study to examine the effects of lubiprostone on nutritional status and lung function in adults with CF. Our hypothesis is that lubiprostone will have beneficial effects on nutritional status.

NCT ID: NCT00577018 Completed - Constipation Clinical Trials

Efficacy and Safety Study of the Effect of Dose-Titration of Prucalopride for The Treatment of Chronic Constipation

Start date: August 1998
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine the safety profile of 4 mg prucalopride in the treatment of chronic constipation.

NCT ID: NCT00576810 Completed - Constipation Clinical Trials

Sodium Picosulphate vs. Placebo in Functional Constipation

Start date: October 2007
Phase: Phase 3
Study type: Interventional

The objective ot the study is to compare the efficacy and safety of 4 weeks treatment with sodium picosulphate drops 10mg to placebo in patients with functional constipation. In addition the effect of treatment on quality of life and general health status will be evaluated

NCT ID: NCT00576511 Completed - Clinical trials for Chronic Constipation

Effect of Prucalopride in Patients With Severe Chronic Idiopathic Constipation

Start date: December 1994
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether prucalopride is safe and effective in patients with severe chronic constipation.

NCT ID: NCT00575614 Completed - Constipation Clinical Trials

Prucalopride in Patients With Chronic Idiopathic Constipation

Start date: April 1997
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether prucalopride is safe and effective in the treatment of chronic idiopathic constipation. Hypothesis: Prucalopride given at a dose of 1 mg o.d. for 4 weeks to female patients with chronic constipation shows a favourable effect on most of the efficacy parameters assessed in this trial. This dosage can be considered safe and generally well-tolerated.

NCT ID: NCT00571896 Completed - Constipation Clinical Trials

The Use of SennaS for Prevention of Post-operative Constipation After Urogynecologic Surgery

Start date: January 2008
Phase: Phase 2/Phase 3
Study type: Interventional

We are doing this study to see if using an over the counter mild laxative, SennaS, there is a difference in time required to have a bowel movement in women who are having surgery for prolapse (when your uterus and/or vagina drop after childbirth or with age) and/or incontinence (when you leak urine or stool without your control) as compared to a sugar pill or placebo.

NCT ID: NCT00564707 Recruiting - Clinical trials for Levator Ani Syndrome With Pain and/or Constipation Symptoms.

Comparison of Biofeedback vs. Botox Injection to Treat Levator Ani Syndrome

Start date: August 2007
Phase: N/A
Study type: Interventional

Purpose: To assess whether EMG directed biofeedback therapy or Botulinum toxin type A injection of the levator ani muscles has any effect on pain from the levator ani syndrome, and, in addition, to what extent either treatment is superior to the other in terms of anorectal physiologic measurements, and quality of life. Study Design: Randomized, prospective, unblinded double-armed study with crossover. Methodology: Female subjects, aged 18 and over, with painful levator ani muscle spasm for at least one month duration will be randomized to receive either biofeedback therapy or Botulinum toxin type A injection. After randomization they will all undergo visual analog pain scoring, anorectal manometry, colonoscopy (if clinically indicated), and self-reported SF-36 quality of life measurement. Each patient will also complete numerical pain scale scoring, an SF-36, and a satisfaction questionnaire at each treatment visit and follow-up visit. Patients will submit these by mail. Identification numbers will be assigned to each subject for use on the SF-36 and Satisfaction Questionnaires throughout the study. Subjects will again undergo anorectal manometry at the end of their treatment arms. In the biofeedback arm patients will be treated biweekly for up to eight treatments and be provided exercises to practice at home based on their muscle function noted during the biofeedback training session. Subjects will keep a treatment diary of the exercises they do at home to help ensure compliance with the protocol. In the Botulinum toxin injection arm patients will be treated with scheduled injections of the levator ani muscles every six weeks for up to three total injections of 100U each. These injections will be directed to the painful areas of the levator muscles as guided by physical exam and EMG measurements. Should any patient fail their initial randomized treatment assignment (failure defined as "very dissatisfied" or "dissatisfied" on the satisfaction questionnaire), they will then be allowed to cross over to the other study arm. In addition to numerical pain scale scoring, an SF-36 questionnaire and anorectal manometry will also be repeated at the time of crossover. We intend to include all randomized patients in the final data analysis (according to their originally assigned treatment arm), regardless of outcome or reason for dropout, thus making this an "intent-to-treat" analysis. Pivotal Study Definitions: The definition of adequate pain reduction, for the purposes of data analysis, will be a reduction in a subject's mean pain score of two on a numerical pain scale (0-10). Failure of either therapy will be defined as a response of "very dissatisfied" or "dissatisfied" on the satisfaction questionnaire at the end of either biofeedback (eight treatment visits) or Botulinum toxin (three injections) both before and after crossover. Outcomes: We will determine the following for biofeedback therapy and Botulinum toxin type A injection: mean pain reduction, any differences in anorectal physiologic measurements (such as mean resting anal sphincter pressure), any changes in self-reported quality of life, and overall patient satisfaction.