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] - Female diseases of the urinary and reproductive systems and pregancy complications [C13] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10048581 |
E.1.2 | Term | Pelvic pain female |
E.1.2 | System Organ Class | 100000004872 |
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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 |
The primary objective is to determine whether it is possible to achieve acceptable recruitment and retention rates in
two centres (NHS Lothian and NHS Grampian) within defined inclusion/exclusion criteria |
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E.2.2 | Secondary objectives of the trial |
1. To determine the effectiveness and acceptability to patients of the proposed methods of recruitment, randomisation,
drug treatments, use of brain fMRI and followup
2. To determine whether fMRI of the brain is a sensitive approach to determine the mechanism of action of gabapentin
in the management of CPP
3. To determine whether gabapentin is likely to be cost effective given the current level of evidence and uncertainty, and
to ascertain what further evidence is needed for the evaluation of gabapentin |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
l Women aged between 1850
2 Pelvic pain of > 6 months
3 Pain located within the true pelvis or between and below anterior iliac crests, associated functional disability
4 No obvious pelvic pathology at laparoscopy (<6 months and >2 weeks ago)
5 Using effective contraception |
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E.4 | Principal exclusion criteria |
l Known pelvic pathology eg endometriosis, cyst
2 Taking gabapentin or pregabalin or any restricted medications
3 Due to undergo surgery in the next 6 months
4 History of renal impairment
5 Allergic to gabapentin
6 Breast feeding
7 Pregnant or planning pregnancy in the next 6 months |
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E.5 End points |
E.5.1 | Primary end point(s) |
1. The proportion of eligible patients randomised into the study.
2. The proportion of randomised patients who take all their medications and fully complete questionnaires at final
followup. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
To determine the effectiveness and acceptability to patients of the proposed methods of recruitment, randomisation,
drug treatments, use of brain fMRI and followup
2. To determine whether fMRI of the brain is a sensitive approach to determine the mechanism of action of gabapentin
in the management of CPP
3. To determine whether gabapentin is likely to be cost effective given the current level of evidence and uncertainty, and
to ascertain what further evidence is needed for the evaluation of gabapentin |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | Yes |
E.6.4 | Safety | No |
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 | Yes |
E.6.13.1 | Other scope of the trial description |
To determine if we can recruit and retain patients within the given criteria for possible RCT in the future. |
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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 | No |
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 | No |
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
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 3 |
E.8.9.2 | In all countries concerned by the trial days | 0 |