E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Digestive System Diseases [C06] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10066556 |
E.1.2 | Term | Chronic diarrhea |
E.1.2 | System Organ Class | 100000004856 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Main objective of the trial is to describe the efficacy and safety of opium tincture (Dropizol®, Pharmanovia A/S, Denmark) against chronic diarrhea.
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
Title: Opium tincture against chronic diarrhea - Healthy: An investigator initiated, randomized placebo-controlled, double-blinded, clinical trial version: 4.0
Related objectives: Same study aim, same marketed medicament, but with different hypothesis, different endpoints, and different enrolled subjects |
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E.3 | Principal inclusion criteria |
General inclusion criteria • Signed informed consent before any study specific procedures • Able to read and understand Danish • Male or female with an age of 20 years or more • The researcher believes that the participant understands what the study entails, are capable of following instructions, can attend when needed, and are expected to complete the study. • The investigator will ensure that fertile female participants have a negative pregnancy test before each treatment visit and use contraception during the entity of the study. • Specific underlying pathophysiology has been identified, but targeted treatment (e.g. antibiotics or bile acid sequestrants) and treatment with loperamide has failed. OR • No specific underlying pathophysiology has been identified and treatment with loperamide has failed. • At least 6 months post-surgery in the gastrointestinal tract • No sign of cancer at standard clinical follow-up • Chronic diarrhea defined as at least 3 daily bowel movements for the last week
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E.4 | Principal exclusion criteria |
Exclusion criteria: • Known allergy towards pharmaceutical compounds similar to Dropizol. • Participation in other studies within 14 days of first visit (1 year if opioids involved). • Expected need of medical/surgical treatment during the study • History of psychiatric illness (e.g. mental retardation, schizophrenia, major depression) • History of substance abuse (e.g. alcohol, THC, benzodiazepine, central stimulants and/or opioids) • Family history of substance abuse • Known major stenosis of the intestines • Metal implants or pacemaker • Severe decreased renal function (defined as eGFR below 30) • Severe decreased hepatic function (defined as Child-Pugh class B or higher) • Treatment with MAO- inhibitors during the entity of the study • Severe COPD or acute severe asthma (defined as FEV1 below 50 % or acute ongoing exacerbation) • Cor pulmonale • Female participants that are lactating • Medicine known to affect gastrointestinal motility must not be initiated during the entity of the study • Treatment with opium tincture during the last month
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E.5 End points |
E.5.1 | Primary end point(s) |
To evaluate change in average number of bowel movements per day from baseline to the time of maximum dose of 10 drops opium tincture three times daily
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Average of baseline period and average of day 4-6 of active treatment |
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E.5.2 | Secondary end point(s) |
Secondary endpoints: 1. To assess regional gastrointestinal transit times and contractions with opium tincture. 2. To assess mental function with opium tincture. 3. Measure change in continuous reaction time 4. To evaluate subjective symptoms of diarrhea
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1. at baseline and during treatment 2. at baseline and at the end of treatment 3. at baseline and at the end of treatment 4. at baseline, during treatment and at the end of treatment
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |